[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rotator-cuff-tear\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rotator-cuff-tear":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,39,71,97,126,150,183,206,230,257,284,307,331,355,379,403,425,446],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100644074","preoperative-central-sensitization-and-postoperative-outcomes-after-arthroscopic-rotator-cuff-repair-100644074",false,"NCT07667257","Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair","Effect of Central Sensitization on Postoperative Clinical Outcomes in Patients Undergoing Arthroscopic Rotator Cuff Repair","ARCS","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Age between 18 and 65 years\n* Diagnosis of rotator cuff tear confirmed by clinical examination and magnetic resonance imaging (MRI)\n* Scheduled to undergo arthroscopic rotator cuff repair\n* Ability to understand and complete study questionnaires\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Previous surgery on the affected shoulder.\n* Concomitant shoulder disorders requiring additional surgical procedures (e.g., fracture, instability, advanced glenohumeral osteoarthritis).\n* History of inflammatory rheumatic disease, active infection, or malignancy affecting the shoulder.\n* Neurological disorders that may influence pain perception or upper extremity function.\n* Severe psychiatric illness or cognitive impairment preventing completion of the questionnaires.\n* Pregnancy.\n* Inability or unwillingness to provide written informed consent.\n* Inability to attend the postoperative 3-month follow-up evaluation.","ALL","18 Years","65 Years",{"count":21,"type":22},50,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated.\n\nAdult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.",[26],"Rotator Cuff Tear","NOT_YET_RECRUITING","2026-06-20",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":22},"2026-06-30",{"date":35,"type":22},"2026-12-30",{"name":37,"class":38},"Medipol University","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":48,"conditions":49,"keywords":53,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100508867","post-market-clinical-follow-up-pmcf-study-of-the-pitch-patch-for-the-augmentation-or-reinforcement-of-the-rotator-cuff-100508867","NCT05906004","Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff","Inclusion Criteria:\n\n* Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years prior to enrolment.\n* Patient has a baseline Constant Murley Score (CMS), assessed within 30 days prior to implantation of the device.\n* Patient must be 16 years old or above.\n* Patient is willing to participate in the study, and having been informed of the nature of the study, has provided written informed consent as approved by the Ethics Committee (EC).\n\nExclusion Criteria:\n\n\\- The Pitch-Patch has been used outside its intended use.","16 Years",{"count":47,"type":22},37,"This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions.\n\nThe medical device in this study is already on the market and is manufactured by Xiros Ltd.\n\nThe Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair.\n\nThe study will collect data on patients who meet the entry criteria and have received the device.\n\nThis is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the study is expected to be 3 years.\n\nA minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline, procedure, and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.",[26,50,51,52],"Rotator Cuff Tears","Rotator Cuff Tears of the Shoulder","Rotator Cuff Injuries",[54,55,56,57,58],"Rotator Cuff Reinforcement","Rotator Cuff Repair","Pitch-Patch","Xiros","Rotator Cuff Augmentation","RECRUITING","2026-05-12",{"date":62,"type":31},"2026-05-15",{"date":64,"type":22},"2026-05",{"date":66,"type":22},"2029-12",{"name":68,"class":69},"Xiros Ltd","INDUSTRY",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100635892","retro-prospective-postmarket-clinical-study-for-fx-shoulder-solutions-shoulder-systems-100635892","NCT07558590","RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS","Inclusion Criteria:\n\n* Indication for hemi or total shoulder replacement with one of the FX SHOULDER SOLUTIONS Shoulder Systems, according to its IFU and surgical technique.\n* Patient aged 18 years and above\n* Patient insured with a social security system\n* Has been informed and did consent to participate to the study.\n\nExclusion Criteria:\n\n* Neurological pathologies compromising the shoulder stability\n* Morbid obesity\n* Muscular deficiencies impairing the shoulder joint",{"count":78,"type":22},1004,"This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS.\n\nThe included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term.\n\nSecondary objectives are\n\n* Revision rate at each post op visit\n* Range of motion at each post op visit\n* Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit\n* Radiological assessment of implant positioning through geometrical parameters at each post op visit\n* Incidence of complications at each post op visit\n* Qualitative feedback from surgeons on the instrumentation",[81,82,83,26,84,85,86],"Humeral Fracture, Proximal","Glenohumeral Osteoarthritis","Avascular Necrosis of the Head of Humerus","Rotator Cuff Arthropathy","Inflammatory Arthritis","Revision of a Shoulder Prosthesis","2026-04-24",{"date":89,"type":31},"2026-04-30",{"date":91,"type":31},"2020-06-01",{"date":93,"type":22},"2037-06",{"name":95,"class":69},"FX Solutions",22,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":70},"100635670","remote-app-based-rehabilitation-after-rotator-cuff-repair-100635670","NCT07555704","Remote App-based Rehabilitation After Rotator Cuff Repair","Effectiveness of a Combined Intervention Incorporating a Remote Rehabilitation Application for Patients After Arthroscopic Repair of Rotator Cuff Tears: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Demographics: Individuals aged 18 years or older.\n* Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:\n\n  * Clinical Presentation: Persistent shoulder pain and functional deficits (e.g., positive impingement signs or weakness in abduction\u002Fexternal rotation) consistent with rotator cuff pathology.\n  * Radiological Confirmation: Imaging evidence (MRI or high-resolution ultrasound) of a full-thickness supraspinatus and\u002For infraspinatus tendon tear.\n  * Tear Characteristics: Small-to-medium-sized tears (maximum diameter \\\u003C 5 cm) categorized as reparable by the attending surgeon.\n* Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique.\n* Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study.\n* Cognitive and Functional Capacity:\n\n  * Absence of cognitive impairment, with the ability to comprehend and execute complex exercise instructions.\n  * Proficiency in digital literacy, including the regular use of an internet-enabled electronic device (smartphone, tablet, or computer) capable of video-based communication and data transmission.\n* Documentation and Consent:\n\n  * Availability of comprehensive medical records, including pre- and postoperative clinical and radiological data.\n  * Provision of written informed consent by the patient or a legal representative prior to enrollment\n\nExclusion Criteria:\n\n* Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury.\n* Complex or irreparable rotator cuff tears, defined as large or massive tears (\\> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery.\n* Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage.\n* Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases.\n* Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.",{"count":105,"type":22},102,"INTERVENTIONAL",[108],"NA","The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.",[26,111,52],"Telemedecine",[50,52,113,114,115,116],"Telerehabilitation","Mobile Application","Digital Health","Arthroscopic Rotator Cuff Repair","2026-04-21",{"date":119,"type":31},"2026-04-29",{"date":121,"type":22},"2026-04-14",{"date":123,"type":22},"2027-12-31",{"name":125,"class":38},"Hanoi Medical University",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":106,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":70},"100595075","decellularized-human-placental-extracellular-matrix-tissue-for-rotator-cuff-repair-augmentation-100595075","NCT07027735","Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation","ECMRCR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of full thickness rotator cuff tear\n\nExclusion Criteria:\n\n* Partial thickness tears\n* Full thickness subscapularis tears\n* Goutallier grades 3 and 4\n* Prior rotator cuff surgery",true,{"count":135,"type":22},120,[108],"The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high rate of postoperative failure to heal. In such situations, there is a lack of connective tissue establishment between the rotator cuff tendon and the bone. One strategy to attempt to improve healing of the rotator cuff tendon back to the bone is via the use of extracellular matrix allograft. This treatment is composed of tissue from other humans, which is stripped of its cells so that just the scaffolding around the cells remains. This decellularized scaffolding can be placed at the rotator cuff healing site in an attempt to augment healing. Both animal studies and human studies have shown promise with this approach. Of those patients enrolling in the study, 50% will be assigned at random to receive a standard rotator cuff repair AND allograft treatment, while 50% will be assigned at random to receive standard rotator cuff repair WITHOUT allograft treatment. All patients enrolled in the study will also obtain an MRI at one year following surgery in order to assess tendon healing. Of note, one-year postoperative MRIs are not standard following rotator cuff repair - only those enrolled in the study will receive this MRI. There will be no financial consequence of receiving this MRI.",[26],[140],"rotator cuff tear","2026-04-15",{"date":143,"type":31},"2026-04-16",{"date":145,"type":22},"2026-08",{"date":147,"type":22},"2027-07-01",{"name":149,"class":38},"Columbia University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":160,"conditions":161,"keywords":167,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100633787","reliability-and-accuracy-of-a-new-clinical-test-for-biceps-lesions-100633787","NCT07531225","Reliability and Accuracy of a New Clinical Test for Biceps Lesions","Sensitivity and Specificity and Inter-Observer Reliability of a New Test for Lesion of the Long Head of the Biceps","Inclusion Criteria:\n\n* Patients aged 18-70 years presenting with shoulder pain suggestive of biceps pathology.\n* Healthy individuals matched to age, sex, and level of activities to serve as a control group (or the normal contralateral shoulder of the same patient).\n\nExclusion Criteria:\n\n* Patients who prefer conservative treatment.\n* Patients who have biceps belly (biceps fibers) tears.\n* Patients with an unstable shoulder because of the risk of dislocation during performing the new test.\n* Patients with a history of shoulder surgery within the past 6 months.\n* Patients with systemic inflammatory conditions affecting the joints (e.g., rheumatoid arthritis).\n* Patients unable to cooperate with physical examination.\n* Patients with contraindications to the gold standard diagnostic method (e.g., MRI contraindications).","70 Years",{"count":159,"type":22},144,"The purpose of this study is to evaluate the accuracy and reliability of a new physical examination test (referred to as Said's test) for diagnosing injuries to the biceps tendon in the shoulder, specifically lesions of the long head of the biceps and SLAP tears.\n\nDiagnosing biceps injuries during a physical exam can be challenging, and existing standard tests can vary in their accuracy. This study aims to determine if this newly developed physical test is a more sensitive, specific, and reliable tool for doctors to use in a clinical setting.\n\nThe study will enroll 144 adult participants (ages 18 to 70). These participants will be categorized into three groups: patients with isolated SLAP lesions, patients with complex shoulder injuries (such as a rotator cuff tear combined with a biceps lesion), and a control group of healthy individuals or asymptomatic shoulders.\n\nDuring the study, each participant will be examined by two independent doctors who are blinded to the patient's actual diagnosis. The doctors will perform the new physical test alongside traditional shoulder tests (the Speed's and O'Brien tests). To determine the true accuracy of these physical exams, the doctors' findings will be compared against definitive diagnostic methods, which will include an MRI, an MRA, or direct visualization during shoulder arthroscopy.\n\nBy comparing the physical exam results to the gold standard imaging or surgical findings, researchers will calculate the new test's sensitivity, specificity, and inter-observer reliability.",[162,163,164,26,165,166],"Lesion of Long Head of Biceps","SLAP Lesion","Biceps Tendinopathy","Shoulder Injuries","Biceps Instability",[168,169,170,171,172,173,174,175],"Said's Test","Speed's Test","O'Brien Test","Long Head of the Biceps","Bicipital Groove","Diagnostic Accuracy","Sensitivity and Specificity","Inter-observer Reliability","2026-04-09",{"date":141,"type":31},{"date":64,"type":22},{"date":180,"type":22},"2027-06",{"name":182,"class":38},"Assiut University",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":106,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":204,"locationsCount":70},"100624634","research-and-clinical-validation-of-a-wearable-device-based-remote-rehabilitation-system-for-postoperative-rotator-cuff-injury-100624634","NCT07412184","Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury","Inclusion Criteria:\n\n* Age ≥18 years;\n* First-time rotator cuff injury surgery and received surgical treatment at Peking University Third Hospital;\n* MRI shows a tear with a maximum diameter \\\u003C3 cm, confirmed by at least three musculoskeletal rehabilitation radiologists;\n* Possess a mobile device with internet access (e.g., smartphone or tablet) capable of using mobile applications;\n* Able to complete the planned study and follow-ups within 6 months after discharge;\n* No visual, hearing, cognitive, or communication impairments;\n* Able to provide informed and valid consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of serious cardiovascular or cerebrovascular diseases, or cervical spondylosis with nerve damage;\n* Presence of cognitive impairment or vision problems;\n* Stroke, rheumatic disease, neurological disorders, or diseases limiting overall physical function or cardiopulmonary function within the past 2 years;\n* No prior history of shoulder joint injury, and having undergone other surgeries within the past 6 months;\n* Patients who cannot complete the entire cycle or drop out midway;\n* Presence of serious postoperative complications, such as wound infection, venous thromboembolism, etc.",{"count":190,"type":22},72,[108],"This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.",[26],[195,196,197],"Rotator cuff tear","Wearable device","Remote rehabilitation","2026-03-08",{"date":200,"type":31},"2026-03-10",{"date":202,"type":31},"2026-01-23",{"date":123,"type":22},{"name":205,"class":38},"Peking University Third Hospital",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":106,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":70},"100617865","a-randomized-controlled-trial-on-the-effectiveness-of-early-versus-conservative-rehabilitation-following-rotator-cuff-repair-100617865","NCT07324174","A Randomized Controlled Trial on the Effectiveness of Early Versus Conservative Rehabilitation Following Rotator Cuff Repair","Inclusion Criteria:\n\n1. Adults aged 18 years and older\n2. Patients diagnosed with a symptomatic tear of the rotator cuff and listed for surgical repair\n3. Rotator cuff tear confirmed by MRI\n4. Patients screened by the surgeon as suitable to participate\n5. Able to attend out-patient follow-up physiotherapy appointment\n6. Demonstrate the ability and willingness to consent and continue participation in the study\n7. Able to understand Arabic or English Language\n\nExclusion Criteria:\n\nA patient will not be eligible for participation in the study if any of the following criteria apply:\n\n1. Individuals younger than 18 years\n2. Those unable or unwilling to consent or continue with the study.\n3. Moderate to severe arthritis seen on x rays or MRI\n4. Fatty infiltration grade \\>= 3","17 Years","100 Years",{"count":215,"type":22},86,[108],"Background Rotator cuff tears (RCTs) are a common, costly, and often persistent musculoskeletal complaint, with an increasing number of shoulder pain patients undergoing surgical repair each year. Whereas many asymptomatic RCTs can be successfully managed non-surgically, when conservative treatment fails, surgery is recommended. However, there is a lack of consensus on the best approach to postoperative rehabilitation, an important factor in the recovery process of rotator cuff repairs. This study aims to investigate the effectiveness of early versus delayed rehabilitation following rotator cuff repairs.\n\nObjective This study aims to determine the effectiveness of early versus delayed rehabilitation following rotator cuff repairs.\n\nMethod A two-armed, randomized controlled trial will be conducted in an outpatient physical rehabilitation department at a tertiary hospital. The sample will include 88 adults aged 18 years or older with RCTs. From the day after surgery, the intervention will engage in supervised passive range of motion (ROM) exercises, focusing on forward flexion and external rotation. They will receive daily exercise instructions, including table slides and active movements for the elbow, wrist, and hand, while also practicing passive shoulder flexion and abduction based on their pain limits. Participants are encouraged to do gentle pendulum exercises and passive movements three times daily to improve shoulder mobility. Active shoulder exercises will be restricted until six weeks post-surgery to ensure healing. Sling use will decrease by the sixth week, allowing for active ROM exercises to start. Participants in the control group will follow a delayed rehabilitation protocol, learning strict sling immobilization techniques for the first six weeks postoperatively. During this period, sling removal will be allowed only for basic exercises and daily activities, with no other shoulder movements encouraged initially. Sling use will end by the sixth week, followed by the start of active ROM exercises.\n\nOutcome measures will include shoulder ROM, muscle power, a numeric pain scale (NPS), shoulder pain disability index (SPADI), and EQ-5D-5L questionnaires assessed at 3, 6, and 12 months follow-up between the two groups. Rotator cuff integrity will be evaluated using MRI at baseline and at 12 months post-surgery.\n\nConclusion We anticipate that this study will add to the body of knowledge required to make effective treatment choices on the management of patients following rotator cuff repairs. Ultimately, this trial aims not only to influence national rehabilitation guidelines but also to enrich the global evidence base concerning optimal rehabilitation strategies following rotator cuff repair, especially for populations in the Middle East and Gulf regions.",[26],[220],"Rotator cuff tear, post rotator cuff repair, physical rehabilitation, early rehabilitation, delayed rehabilitation","2026-01-07",{"date":223,"type":31},"2026-01-09",{"date":225,"type":22},"2026-01-01",{"date":227,"type":22},"2029-12-30",{"name":229,"class":38},"King Faisal Specialist Hospital & Research Center",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":236,"maxAge":157,"enrollmentInfo":237,"targetDuration":4,"studyType":106,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100586643","fiberlocker-system-augmentation-of-rotator-cuff-repairs-100586643","NCT06918041","FiberLocker® System Augmentation of Rotator Cuff Repairs","Inclusion Criteria:\n\n1. The Subject is between the ages of 30 and 70 years.\n2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)\n3. Tear size ≥ 2 cm\n4. Primary rotator cuff repair\n5. Subject preoperative MRI obtained within 1 year prior to surgery\n\nExclusion Criteria:\n\n1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.\n2. The Subject objects to the use of the FiberLocker® System\n3. History or known allergy or intolerance to polyester\n4. Complete full-thickness subscapularis tears of \\> than the superior 1\u002F3 of the tendon (Lafosse grade 3 and above)\n5. Hamada grade III and above\n6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph\n7. Recurrent shoulder instability\n8. Corticosteroid injection in the operative shoulder within three months before surgery\n9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)\n10. Subjects with current acute infection in the area surrounding the surgical site\n11. Revision rotator cuff repair\n12. Pregnant or planning to become pregnant during the study period\n13. Subject is breastfeeding during the study period\n14. Subject has conditions or circumstances that would interfere with study requirements\n\nIntraoperative Exclusion Criteria:\n\n1. Partial rotator cuff repairs\n2. Lafosse grade 3 or higher subscapularis tears\n3. Limited space for implant delivery\n4. FiberLocker® System cannot be used as indicated","30 Years",{"count":238,"type":22},60,[108],"The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument SN).\n\nThe primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.\n\nThe secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.",[26,50,51],[50,55,243,244,245,246],"Augmentation","Reinforcement","Mechanical Augmentation","Rotator Cuff Degeneration","2025-11-27",{"date":249,"type":31},"2025-12-01",{"date":251,"type":31},"2025-08-05",{"date":253,"type":22},"2028-04-01",{"name":255,"class":69},"ZuriMED Technologies Inc.",4,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":19,"enrollmentInfo":266,"targetDuration":4,"studyType":106,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":70},"100593332","rotator-cuff-tendon-repair-with-fiberlocker-system-patch-augmentation-100593332","NCT07005063","Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation","Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study","FIBERLOCK","Inclusion Criteria:\n\n1. Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure\n2. Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus\n3. The rotator cuff tear is of traumatic origin.\n4. Subject is ≥ 40 years of age \\& ≤ 65 years of age.\n5. Primary rotator cuff repair\n6. Informed Consent signed by the subject\n7. Pre-operative MRI performed\n\nExclusion Criteria:\n\n1. Vulnerable subjects (as defined in ISO 14155)\n2. Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate\n3. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,\n4. Previous enrolment into the current investigation,\n5. Enrolment of the PI, his\u002Fher family members, employees and other dependent persons,\n6. Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject\n7. Active smoker\n8. History of claustrophobia that would prevent an MRI of the index shoulder\n9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder\n10. Pregnant or planning to become pregnant during the study period\n11. Breast feeding women\n12. Subject has conditions or circumstances that would interfere with study requirements.\n13. Contraindications and limitations of the MD as described in the IFUs.\n14. Partial rotator cuff tears\n15. History or known allergy or intolerance to polyester\n16. Complete full-thickness subscapularis tears greater than the superior 1\u002F3 of the tendon, with Lafosse grade 3 or greater\n17. Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear\n18. Limited space or exposure for implant delivery\n19. Structural or pathological condition of the bone or soft tissue that could impair healing.\n20. Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria\n21. Fatty infiltration of the index shoulder rotator cuff muscle \\> Goutallier Score 2\n22. Corticosteroid injection in the operative shoulder within 6 weeks of operation\n23. Subject shows frozen shoulder\u002Fadhesive capsulitis at day of surgery\n24. Cases of moderate to severe osteoarthritis\n25. Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)\n26. Subjects with diabetes type I or II\n27. The subject currently has an acute infection in the area surrounding the surgical site\n28. Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint.\n29. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.","40 Years",{"count":21,"type":22},[108],"The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.",[26,270,271],"Rotator Cuff Injury","Rotator Cuff Rupture",[195,273,243,244,274],"Rotator cuff repair","Mechanical augmentation","2025-07-16",{"date":277,"type":31},"2025-07-17",{"date":279,"type":31},"2025-07-03",{"date":281,"type":22},"2029-06-30",{"name":283,"class":69},"ZuriMED Technologies AG",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":291,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":106,"phases":294,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":306},"100583597","isb-with-ssnb--anb-100583597","NCT06878391","ISB With SSNB & ANB","A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial","Inclusion Criteria:\n\n* a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI)\n* acceptance of arthroscopic surgery including rotator cuff repair\n* age same as or more than 20 years\n* acceptance of preemptive regional block and PCA, and blood testing\n\nExclusion Criteria:\n\n* did not undergo arthroscopic rotator cuff repair\n* stopped PCA before 48 hours postoperatively because of associated side effects\n* a history of previous ipsilateral shoulder operation or fracture\n* a concomitant neurologic disorder around the shoulder\n* a failure of blood sampling including hemolysis, etc.","20 Years",{"count":293,"type":22},100,[108],"This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).\n\nThe study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.",[26],"2025-05-23",{"date":299,"type":31},"2025-05-29",{"date":301,"type":31},"2025-03-24",{"date":303,"type":22},"2027-01-31",{"name":305,"class":38},"Chuncheon Sacred Heart Hospital",2,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":157,"enrollmentInfo":314,"targetDuration":4,"studyType":106,"phases":316,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":70},"100591718","effect-of-vitamin-d-supplementation-on-the-rehabilitation-of-patients-after-rotator-cuff-tear-repair-100591718","NCT06984068","Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair","Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n1. Male and female patients aged between 40 and 70 years.\n2. Clinically and radiologically (magnetic resonance imaging) diagnosed full-thickness supraspinatus tendon tears that were confirmed by arthroscopic surgery and could be surgically repaired.\n3. Degree of supraspinatus tendon tear according to the DeOrio and Cofield grading system as moderate tear (1-3 cm) and mild tear (\\\u003C1 cm).\n4. Serum vitamin D level \\\u003C30 ng\u002FmL \\>20 ng\u002FmL before rotator cuff tears surgery\n5. Signed informed consent and underwent 12-month follow-up.\n\nExclusion Criteria:\n\n1. Presence of other shoulder pathologies such as subscapularis tear, adhesive capsulitis, long head of biceps tendonitis, calcific tendonitis, or shoulder tumor.\n2. Large or unrepairable rotator cuff tear (\\>3 cm).\n3. Previous history of shoulder surgery or recurrent rotator cuff tears.\n4. Combined injury to the shoulder labrum, articular cartilage or biceps tendon.\n5. Contraindications to vitamin D supplementation (e.g., allergies).\n6. Serious comorbidities such as cardiovascular disease.\n7. Severe osteoporosis or rheumatoid arthritis.",{"count":315,"type":22},44,[108],"Rotator cuff tears are a significant health concern that severely affect shoulder joint mobility in patients. Common clinical manifestations of RCTs include shoulder pain, limited range of motion, joint instability, muscle weakness, and functional disability. In patients with rotator cuff tears, the prevalence of vitamin D deficiency ranges from 8.3% to 71%. Given its critical role in muscle strength and function, vitamin D is emerging as an important factor in the management of musculoskeletal disorders, including rotator cuff injuries. Despite the promising evidence regarding vitamin D's role in muscle strength and tendon healing, the specific impact of vitamin D supplementation on postoperative rehabilitation remains unclear. Given that vitamin D deficiency is easily diagnosed and treated, it is considered a modifiable risk factor that could be utilized in orthopedic care to improve patient outcomes. Vitamin D supplementation is a cost-effective and potentially efficient intervention that may enhance muscle strength, reduce postoperative pain, and improve joint function in patients recovering from rotator cuff repair. The objective of this study is to investigate the effects of vitamin D supplementation on postoperative outcomes in patients undergoing arthroscopic rotator cuff repair. The study will be conducted as a randomized controlled trial, with participants receiving either a daily dose of 4000 IU of vitamin D or a placebo. The primary outcomes to be evaluated include muscle strength, postoperative pain, and joint function. Blood samples will be collected at baseline, and after 3 months, 6 months, and 12 months of supplementation to monitor the effects of vitamin D on serum levels and its correlation with clinical outcomes.",[26],[140,320,321],"rotator cuff tear repair","vitamin D","2025-05-14",{"date":324,"type":31},"2025-05-22",{"date":326,"type":22},"2025-06",{"date":328,"type":22},"2028-11",{"name":330,"class":38},"Chinese University of Hong Kong",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":19,"enrollmentInfo":338,"targetDuration":4,"studyType":106,"phases":339,"briefSummary":340,"conditions":341,"keywords":342,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":70},"100587109","blood-flow-restriction-exercise-induced-hypoalgesia-100587109","NCT06924112","Blood Flow Restriction Exercise-induced Hypoalgesia","Exercise-induced Hypoalgesia Following Blood Flow Restriction in Rotator Cuff Repair Rehabilitation: a Randomized Crossover Clinical Trial","Inclusion Criteria:\n\n* Age between 40-65 years.\n* Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging.\n* Undergoing arthroscopic rotator cuff repair\n* Be able to read and understand Spanish.\n\nExclusion Criteria:\n\n* Massive irreparable RC tears, concomitant fracture, labral or nerve injury.\n* Suspicion of developing\u002Fdiagnosis a frozen shoulder.\n* Revision surgery after RC repair.\n* Previous corticosteroid injection (\\\u003C 1 year).\n* Recent surgery (\\\u003C 1 year) in the contralateral shoulder.\n* A history of deep venous thrombosis\u002Fpulmonary embolism.\n* Peripheral vascular disease, thrombophilia or clotting disorders.\n* Severe or uncontrolled hypertension, or any comorbid condition that prevents participants from complete the intervention.",{"count":96,"type":22},[108],"The goal of this crossover randomized clinical trial is to compare the acute effect on exercise-induced hypoalgesia (EIH) between isometric exercise with blood flow restriction (BFR) and isometric exercise alone in adults undergoing arthroscopic rotator cuff repair. It is presumed that the addition of BFR to isometric exercises induces a greater effect in EIH.\n\nPatients who agree to participate in this research will be randomly assigned to two intervention sequences (AB or BA), where intervention A (experimental) corresponds to isometric exercises with BFR, and intervention B (control) corresponds to isometric exercises alone. For one week, each participant attended two sessions, separated by a 72-hours wash-out period. The primary variables will be the pressure pain threshold (PPT) and conditioned pain modulation (CPM). Secondary variables will be the pain intensity and distribution, kinesiophobia, upper extremity disability, and quality of life. Results will be measured before intervention (T1, pre-intervention), immediate after intervention (T2, post-intervention 1) and 10 minutes after intervention (T3, post-intervention 2).",[270,26,55],[343,344,345],"blood flow restriction therapy","blood flow restriction training","exercise-induced hypoalgesia","2025-04-04",{"date":348,"type":31},"2025-04-11",{"date":350,"type":22},"2025-05-01",{"date":352,"type":22},"2025-09-30",{"name":354,"class":38},"University of Valencia",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":106,"phases":365,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":70},"100575003","phase-2-exploring-the-feasibility-of-silk-fibroin-surgical-mesh-in-rotator-cuff-tears-repair-enhancement-100575003","NCT06766630","Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement","Inclusion Criteria:\n\n* Preoperative:\n\n  1. Age range of 50-75 years old (inclusive), gender not limited;\n  2. Patients who require surgery due to rotator cuff tears detected by clinical and MRI examination;\n  3. Evaluated as type IV and above according to Sugaya classification criteria;\n  4. Patients with persistent or recurrent pain in the shoulder for more than 3 months;\n  5. Full layer tendon tear of 1-5cm or full layer or complete tear of supraspinatus and\u002For infraspinatus tendon;\n  6. History of non-surgical treatment failure;\n  7. Understand the purpose of the trial, cooperate with surgical treatment and follow-up, voluntarily participate in the trial and sign an informed consent form;\n\n     Intraoperative:\n  8. Confirmed as a full-thickness tear of 1-5cm on the rotator cuff;\n  9. Tendons can cover more than 50% of the humeral greater tuberosity of the shoulder joint.\n\nExclusion Criteria:\n\n* 1\\. Pregnant and lactating women; 2.Individuals with contraindications for surgery or anesthesia, as well as those who are allergic to known ingredients of implanted products; 3. Unable to undergo MRI examination due to claustrophobia and other reasons; 4. Individuals with a history of rotator cuff repair on the affected side, or combined with other bone, joint, or muscle soft tissue injuries in the same limb; 5.Patients with subscapular muscle injury; 6.Those with any combination of diseases or symptoms that may affect the evaluation of efficacy, such as Hamada classification of grade 3 shoulder joint disease; 7.Those with residual rotator cuff tendon fatty infiltration ≥ grade 3 by Goutallier classification; 8.Individuals who have taken oral steroids or received steroid injections within 6 weeks prior to surgery; 9.Those who have participated in other interventional clinical trials within the past 3 months prior to the conduct of this trial; 10. Researchers believe that clinical trial participants who are not suitable for participation include but are not limited to those with uncontrolled blood sugar levels, heavy drinkers, smokers, and others who affect repair and healing.","50 Years","75 Years",{"count":364,"type":22},20,[366,367],"PHASE2","PHASE3","Rotator cuff tears result in shoulder joint pain and movement disorders, affecting patients' daily lives. The incidence rate rises with age and can be as high as 54% among people over 60 years old. Most rotator cuff tears are unable to heal spontaneously, and the tear area may gradually expand over time. Currently, the main surgical treatment for rotator cuff tears is to use suture anchors to stitch the rotator cuff tendon tissue back to the original anatomical insertion point. Large rotator cuff tears are often accompanied by fat infiltration and tendon retraction. When forcefully sutured, the tension is relatively high, which may lead to non-healing and re-tearing of the rotator cuff. Research indicates that the re-tear rate after rotator cuff tear repair is 20% - 30%, and this probability can reach 40% - 50% for large rotator cuff tears. For these irreparable and large tears, rotator cuff repair typically requires patch augmentation techniques. Surgeries are based on restoring the force couple effect of the rotator cuff as much as possible and covering it with repair materials to achieve reinforcement. Silk fibroin surgical mesh is made of silk fibroin which has good biocompatibility and can be generally placed in the area of rotator cuff tears that cannot be repaired through conventional surgeries. By providing support to the injured rotator cuff tissue, it improves the repair effect. It can reestablish the integrity of the rotator cuff, reducing mechanical tension at the repair site and maintaining the stability of the glenohumeral joint. Besides, it can also promote tissue healing, and cell infiltration and growth, thereby facilitating the biological repair of the injured rotator cuff and reducing the occurrence of postoperative re-tears.",[26],"2025-01-08",{"date":372,"type":31},"2025-01-09",{"date":374,"type":31},"2024-12-19",{"date":376,"type":22},"2026-12-19",{"name":378,"class":38},"Weiliang Shen, Ph.D., M.D.",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":106,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":306},"100333150","superior-capsular-reconstruction-vs-partial-repair-for-massive-rotator-cuff-tears-100333150","NCT03617562","Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears","Arthroscopic Partial Repair vs. Superior Capsular Reconstruction for Massive Irreparable Rotator Cuff Tears: A Pilot Randomized and Controlled Trial","SCR","Inclusion Criteria:\n\n* Symptomatic shoulder pain and\u002F or weakness (regardless of baseline range of motion\u002F psuedoparalysis)\n* Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus.\n* Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications\n* Irreparable tear determined intra-operatively using standard arthroscopic techniques\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Absence of subscapularis muscle insertion, or irreparable subscapularis tear\n* Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+)\n* Acute tears (within 6 months)\n* Neurologic injury causing paralysis of affected shoulder \u002F arm\n* Any previous surgery to the affected shoulder\n* Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher)\n* Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.)\n* Are there any non-orthopedic comorbidities that put the patient at significant risk?",{"count":388,"type":22},70,[108],"Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established.\n\nThe long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.",[26],[393,165],"Massive Rotator Cuff Tear","2024-09-11",{"date":396,"type":31},"2024-09-19",{"date":398,"type":31},"2018-07-18",{"date":400,"type":22},"2028-07",{"name":402,"class":38},"Sunnybrook Health Sciences Centre",{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":106,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":70},"100561480","perioperative-polmacoxib-reduce-opioid-consumption-for-post-operative-pain-after-rotator-cuff-tear-100561480","NCT06590714","Perioperative Polmacoxib Reduce Opioid Consumption for Post Operative Pain After Rotator Cuff Tear.","Inclusion Criteria:\n\n* patients over 18 years of age\n* Patients who need rotator cuff rupture or rotator cuff surgery with MRI identified osteoarthritis (especially small and medium SST dominant rupture)\n* NSAIDs unadministered patients for more than 1 month\n* Ultracet unadministered patients for more than 1 month\n\nExclusion Criteria:\n\n* primary fiftieth shoulder\n* including short-lived frozen shoulders\n* infectious arthritis\n* previous corticosteroid injections\u002Fsurgery\n* moderate-severe arthroplasty\n* a traumatized patient\n* a central or peripheral nervous system disease\n* a mental illness that may not conform to medical or physical therapy\n* a woman of childbearing age\n* Pregnancy\n* a severe gastrointestinal ulcer",{"count":410,"type":22},150,[108],"1. \\*\\*One day (±1 day) before surgery:\\*\\* The investigator or designated study staff will thoroughly explain the clinical trial process to the participant and their guardian (representative) based on the informed consent form and provide the form so that all participants and their guardians have sufficient time to read, discuss, and decide. Participants who agree to participate in the clinical trial will voluntarily sign the written consent form and receive a copy of the signed consent form before any study-related procedures are conducted. The clinical trial site will assign a screening number to patients who voluntarily provide consent and undergo screening. The screening number can be assigned in the order in which the participants sign the consent within the study site. After confirming eligibility based on inclusion\u002Fexclusion criteria, randomization will be performed to assign participants to either the treatment group or the control group (with a 1:1 ratio). If assigned to the treatment group, participants will receive \\'Polacoxib (preventive Acelex cap 2mg) once daily, NSAIDs-excluded non-opioid\u002Fopioid analgesics - PRN use.\\' If assigned to the control group, participants will receive NSAIDs-excluded non-opioid or opioid analgesics. Data will be collected by comparing the two groups in a double-arm setup. Pain scores, UCLA\u002FASES scores, and joint range of motion will be collected, and this data will be valid up to 3 months before the surgery. (For patients taking NSAIDs or Ultracet, the dose will be maintained until v5.)\n2. \\*\\*Two hours before surgery:\\*\\* Administration of medication begins.\n3. \\*\\*Three days after surgery:\\*\\* Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses (post-surgery). Non-opioid or opioid analgesics (e.g., Fentanyl injection or Ultracet) will be used to manage post-surgical pain, and the number of doses will be collected to assess the participant's pain.\n4. \\*\\*Two weeks after surgery:\\*\\* An outpatient visit will be conducted one week after discharge. Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses at the two-week mark.\n5. \\*\\*Six weeks after surgery:\\*\\* Collect pain scores and the cumulative number of NSAIDs-excluded non-opioid or opioid analgesic doses.\n6. \\*\\*Three months after surgery:\\*\\* MRI will be performed to check for re-tears (optional for participants). This visit will be the study's completion visit, during which pain scores, UCLA\u002FASES scores, joint range of motion, and cumulative doses of NSAIDs-excluded non-opioid or opioid analgesics will be collected. If adverse events occurring during the treatment period have resolved before this completion visit, no additional safety follow-up will be performed, and this visit will be considered the end of the clinical trial. If adverse events have not resolved by the completion visit, follow-up will continue until the adverse events have either returned to pre-study or baseline levels, or the principal investigator or designee determines that the adverse events have stabilized, or no further follow-up is deemed necessary. This follow-up will mark the completion of the clinical trial.",[26],[140,415,416],"reduction of Opioids","Effects of Polmacoxib Administration","2024-09-06",{"date":396,"type":31},{"date":420,"type":31},"2024-08-23",{"date":422,"type":22},"2025-08-31",{"name":424,"class":38},"Eulji University Hospital",{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":212,"maxAge":362,"enrollmentInfo":432,"targetDuration":4,"studyType":106,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":70},"100561196","application-of-shock-wave-technique-in-conservative-treatment-of-rotator-cuff-tear-100561196","NCT06587009","Application of Shock Wave Technique in Conservative Treatment of Rotator Cuff Tear","Director of Rehabilitation Medicine","Inclusion Criteria:\n\n* Identify patients with rotator cuff tears and choose conservative treatment\n* Able to complete cardiopulmonary exercise tests\n* Able to cooperate with rehabilitation training and complete questionnaire survey\n\nExclusion Criteria:\n\n* Previous shoulder surgery history\n* Irreparable rotator cuff damage\n* Retear after ARCR",{"count":96,"type":22},[108],"This study is a prospective cohort study and is a single-center clinical trial. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.",[26],[437,438],"Shock wave technique","Conservative treatment","2024-09-04",{"date":396,"type":31},{"date":442,"type":31},"2024-05-05",{"date":444,"type":22},"2025-12-30",{"name":205,"class":38},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":430,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":106,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":463,"locationsCount":70},"100559408","study-on-the-application-of-shock-wave-technique-after-rotator-cuff-operation-100559408","NCT06563739","Study on the Application of Shock Wave Technique After Rotator Cuff Operation","Inclusion Criteria:\n\n1. A rotator cuff tear was diagnosed and surgery was required\n2. Able to complete cardiopulmonary exercise tests\n3. Able to cooperate with rehabilitation training and complete questionnaire survey\n\nExclusion Criteria：\n\n1. Age \\\u003C17 years or age \\>75 years\n2. Previous shoulder surgery history\n3. Irreparable rotator cuff damage",{"count":388,"type":22},[108],"This study is a prospective cohort study and is a single-center clinical trial. The subjects of this study were patients who underwent rotator cuff repair in the Department of Sports Medicine and the Department of Rehabilitation in the Third Hospital of Beijing Medical University. The sample size of this study is about 2600 cases. We will collect the results of shoulder joint function score, quality of life score, pain score and MRI examination of all participants at baseline. Meanwhile, epidemiological data and related clinical characteristics of patients will be collected at the time of enrollment. All the collected data information was entered into the computer for statistical analysis, and the prognosis of patients under different programs was evaluated.",[26],[437],"2024-08-19",{"date":459,"type":31},"2024-08-21",{"date":442,"type":31},{"date":462,"type":22},"2024-12-30",{"name":205,"class":38}]