[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arthroscopic-rotator-cuff-repair\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arthroscopic-rotator-cuff-repair":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100589894","long-term-clinical-outcome-after-arthroscopic-rotator-cuff-repair-augmentation-with-autologous-microfragmented-lipoaspirate-tissue-100589894",false,"NCT06960343","Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue","Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trialin Question Won by Our Research Group.","Inclusion Criteria:\n\n* Age \\> 18 years\n* Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification)\n* Indication for arthroscopic rotator cuff repair\n* Informed consent to participate in the study\n* Informed consent to participate for the duration of the study\n\nExclusion Criteria:\n\n* Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification)\n* Massive rotator cuff tear (C4 according to the SCOI classification)\n* Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification)\n* Associated anterior, posterior, or multidirectional shoulder instability\n* Indication for repair of a SLAP lesion of the biceps anchor\n* Grade III or IV muscle atrophy of the supraspinatus and infraspinatus tendons (according to Goutallier or Fuchs classification)\n* Intra-articular hyaluronic acid or corticosteroid infiltration within 3 mo from the planned surgical procedure\n* Medical comorbidities contraindicating arthroscopic shoulder surgery\n* Local (shoulder, abdominal region, gluteal region) or systemic infection, osteomyelitis, or sepsis\n* Diabetes mellitus, untreated thyroid disease, chronic kidney disease, rheumatoid arthritis\n* Immunodeficiency\n* Chronic disorders involving coagulation, platelet aggregation, or severe coagulopathy\n* Severe cardiovascular disease\n* Stroke or acute cardiovascular event within 6 mo from the planned surgical procedure\n* Weight loss for any cause .30 kg in 12 mo or .10 kg in 12 mo without a cause\n* Eating disorders or body dysmorphic disorder\n* Varices, phlebitis, or scars next to the planned adipose tissue harvesting site\n* Alcohol\u002Fdrug addiction or psychiatric disease compromising compliance with postoperative protocols\n* Pregnancy or breastfeeding women\n* Informed consent not accepted","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","OBSERVATIONAL","Specific Aims :\n\nThe aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic rotator cuff repair.\n\nThe primary goal of this study was to test the following hypothesis: an intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology could improve the clinical outcomes of single-row arthroscopic rotator cuff repair in terms of points in the Constant-Murley score (CMS) collected at least 5 years after surgery.\n\nBackground and Significance:\n\nRotator cuff surgery was initially proposed at the end of the 19th century and evolved then from open to arthroscopic techniques, rising quickly from a minor niche to a fully recognized subspecialty.\n\nTo improve clinical and functional results and reduce the retear rate, new fixation techniques and biological solutions to enhance tendon healing are being developed at a fast pace, as shown by the dramatic increase in the number of articles published per year.\n\nBiological solutions to enhance rotator cuff healing include growth factors and platelet-rich plasma, as well as mesenchymal stem cells (MSCs) and their derivatives.\n\nMSCs are believed to enhance tissue healing mainly through stimulation of local cells via paracrine mechanisms and anti-inflammatory and\u002For immunomodulatory activity, thus creating a suitable microenvironment for tissue repair.\n\nAutologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of adipose derived MSCs (ADSCs) to support and accelerate tissue regeneration. Lipoaspirates contain human ADSCs and produce growth factors, such as platelet-derived growth factor, fibroblast growth factor, transforming growth factor beta, and vascular endothelial growth factor, which play important regulatory roles in cellular functions, including adhesion, chemotaxis, proliferation, migration, matrix synthesis, differentiation, and angiogenesis.\n\nHerewith, autologous microfragmented lipoaspirate tissue is expected to optimize the microenvironment for tendon regeneration. Among many approaches, devices relying on nonenzymatic methods and avoiding the use of additives and other additional manipulations (eg, centrifugation) allow one to harvest, process, and obtain autologous microfragmented lipoaspirate tissue directly in the operative theatre under sterile conditions. This permits immediate use in the same surgical intervention without delays owing to the difficulty of an ex vivo cell expansion and the complexity of the current good manufacturing practice requirements for preparing cells for therapeutic use.\n\nAlthough several animal studies have been published showing promising results for the use of ADSCs in enhancing the healing of rotator cuff tears, minimal evidence describing augmentation of rotator cuff treatment with lipoaspirate.\n\nPreliminary Studies\u002FProgress Report:\n\nThis study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). The previous study demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair.\n\nNevertheless, no significant differences emerged between the groups in terms of rerupture rate, complication rate, number of adverse events, and mid-term clinical outcomes.\n\nA previous in vitro study showed that autologous microfragmented adipose tissue significantly increases the proliferation rate of human tendon stem cells without altering their stemness and differentiation capability. Moreover, treated cells increase the expression of VEGF, which is crucial for the neovascularization of the tissue during the healing process.\n\nResearch Design and Method:\n\nAt least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer.\n\nDuring the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.",[24,25,26],"Arthroscopic Rotator Cuff Repair","Augmentation","Microfragmented Adipose Tissue","RECRUITING","2026-04-27",{"date":30,"type":31},"2026-04-28","ACTUAL",{"date":33,"type":31},"2025-04-11",{"date":35,"type":20},"2026-10-11",{"name":37,"class":38},"University of Milan","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":39},"100590608","shoulder-anterior-capsular-block-for-postoperative-analgesia-in-arthroscopic-rotator-cuff-repair-surgery-100590608","NCT06969625","Shoulder Anterior Capsular Block for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery","Shoulder Anterior Capsular Block Versus Combined Suprascapular and Axillary Nerve Blocks for Postoperative Analgesia in Arthroscopic Rotator Cuff Repair Surgery","Inclusion Criteria:\n\n* Patients acceptance\n* Age: 21-60 years\n* Sex: both sexes (males or females).\n* Physical status: ASA 1\\& II.\n* Body mass index (BMI) ≤ 30 kg\u002Fm2\n* Type of operation: arthroscopic rotator cuff repair surgery.\n* Duration of surgery: within 2 hours.\n\nExclusion Criteria:\n\n* Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)\n* Patients with known history of allergy to the study drugs.\n* patients with neuropathy involving the limb undergoing surgery\n* Advanced hepatic, renal, cardiovascular, and neurologic diseases.\n* history of previous shoulder operation or fracture.\n* conversion to open surgery from arthroscopy.\n* pregnant females\n* patients with chronic opioid use","21 Years","65 Years",{"count":50,"type":20},60,"INTERVENTIONAL",[53],"NA","Shoulder pain is frequently encountered in the medical field. Rotator cuff tears are the most common cause. Shoulder pain affects quality of life and delay rehabilitation programs.\n\nEffective control of post operative pain is a cornerstone in the success of these surgeries. Regional anaesthesia is often favoured for shoulder surgery as it could effectively provide anaesthesia and postoperative analgesia. Additionally, the upper limb has multiple nerve targets that can be blocked. Ultrasound combined SSNB-ANB were described as an alternative to interscalene nerve block for shoulder surgeries equipotent pain relief and patient satisfaction as well as fewer complications due to the location of injection.\n\nUltrasound guided SHAC block is a motor sparing block which targets all nerves supplying shoulder consistently at two sites. It was validated in chronic shoulder pain patients. However, there is no sufficient evidence for this block in postoperative pain after shoulder surgery.",[24],[57,58,59,60],"shoulder anterior capsular block","combined suprascapular and axillary nerve blocks","postoperative analgesia","arthroscopic rotator cuff repair surgery","2025-05-13",{"date":63,"type":31},"2025-05-14",{"date":65,"type":20},"2025-06-01",{"date":67,"type":20},"2026-01-30",{"name":69,"class":70},"Zagazig University","OTHER_GOV",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":51,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":39},"100538585","rotator-cuff-repair-with-magnesium-pin-100538585","NCT06292754","Rotator Cuff Repair With Magnesium Pin","Augmentation of Rotator Cuff Repair With Biodegradable Magnesium Pin: From Bench Side to Bedside","Inclusion Criteria:\n\n* Subject requires Arthroscopic rotator cuff repair (ARCR) and amenable to repair.\n* Subject is \\> 40 years of age (no upper limit);\n* Subject provides written informed consent for study participation using an Independent Ethical Committee (IEC) \u002F Institutional Review Board (IRB) approved consent form;\n* Subject is willing and able to participate in required follow-up visits and is able to complete study activities.\n\nExclusion Criteria:\n\n* Subjects who are unable to tolerate magnetic resonance imaging (MRI), due to psychiatric or medical contraindications;\n* Subjects with Samilson-Prieto osteoarthritis \\> 2;\n* Subjects with current or prior infection of the ipsilateral shoulder;\n* Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, or chronic joint disease;\n* Subjects with prior shoulder surgery (not including rotator cuff repair (revision repair subject group only), biceps tenodesis\u002Ftenotomy, distal clavicle excision (DCE), ubacromial decompression);\n* Subjects with an irreparable or partially reparable rotator cuff tear;\n* Subjects with a subscapularis tear requiring repair;\n* Subjects requiring a concomitant labral fixation procedure;\n* Subjects requiring a concomitant os acromiale fixation procedure\n* Subjects with glenohumeral joint instability (multiple dislocations\u002Fsubluxations);\n* Subjects with a subacromial or intra-articular injection within 3 months prior to surgery;\n* Subjects with condition(s) that contraindicate or complicate outcomes of ARCR e.g., \\> Hamada 3 rotator cuff arthropathy on X-ray, Goutallier atrophy \\> Grade 3, proximal humeral fracture or scapular fracture, avascular necrosis of the humeral head or glenoid, history of immunodeficiency disorders, history of chronic inflammatory disorders, oral or injected steroid use in last 4 weeks;\n* Pregnancy or possibility of pregnancy\n* Patient's inability to understand written and spoken Chinese, Mandarin or English.","40 Years",{"count":80,"type":20},40,[53],"Rotator cuff tears are one of the most common conditions encountered in orthopaedic practice leading to significant shoulder pain and functional deficit. The incidence of rotator cuff tears increases with age and previous trauma. Arthroscopic rotator cuff repair (ARCR) is a surgical procedure to reattach the torn edge of the tendon to the underlying bone, which can improve the clinical symptoms of patients. However, the retear rate after arthroscopic repair is as high as 94% (1). The high re-tear rate following cuff repair is due to the lack of a strong tendon to bone integration. The natural healing responses after surgical reattachment are too weak to regenerate strong tendon insertion, primarily owing to insufficient osteogenesis. To enhance the bone-tendon interface (BTI) healing, the investigators have developed a magnesium pin that can be applied to the cuff repair site to improve the BTI healing.This study is a single-center, randomized controlled trial to investigate the effect of using magnesium pin as a suture to augment rotator cuff repair. The intervention groups receives treated using magnesium pin additional to the suture anchor used routinely in clinical practice, whereas the control group receives routine suture anchor for the treatment-as-usual (TAU). The investigators hypothesize the magnesium pin applied in arthroscopic rotator cuff tears can promote BTI healing and reduce the cumulative retear rate with better functional outcomes.",[24],[85,86],"ARCR","Magnesium pin","NOT_YET_RECRUITING","2024-02-27",{"date":90,"type":31},"2024-03-05",{"date":92,"type":20},"2024-05",{"date":94,"type":20},"2026-12",{"name":96,"class":38},"Chinese University of Hong Kong"]