[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proximal-humerus-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proximal-humerus-fracture":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,84,111,139],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645227","post-market-clinical-follow-up-pmcf-study-evaluating-the-safety-and-efficacy-of-tpmed-shoulder-prosthesis-system-100645227",false,"NCT07678034","Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System","Inclusion Criteria:\n\n* Individuals aged 18 years and older,\n* Male or female participants,\n* Participants who have undergone Reverse Shoulder Arthroplasty or Shoulder Hemiarthroplasty for any valid indication,\n* Participants in whose surgical procedure the Tipmed™ Shoulder Prosthesis System product configurations were utilized.\n* Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).\n* Participants who have voluntarily signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Concurrent participation in any other interventional clinical trial.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","OBSERVATIONAL","This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.",[24,25,26,27,28],"Glenohumeral Osteoarthritis","Proximal Humerus Fracture","Rotator Cuff Arthropathy","Rheumatoid Arthritis","Avascular Necrosis",[30,31,32,33,34],"Reverse Shoulder Arthroplasty","Shoulder Prosthesis","Shoulder Hemiarthroplasty","Post-Market Clinical Follow-Up (PMCF)","Modified Constant-Murley Score","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2025-06-16",{"date":43,"type":20},"2030-06-15",{"name":45,"class":46},"TIPMED Medical Device Manufacturing Ltd. Co.","INDUSTRY",4,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100597605","study-on-outcomes-of-proximal-humerus-fractures-100597605","NCT07060664","Study on Outcomes of Proximal Humerus Fractures","Review of Proximal Humerus Fracture Outcomes","Inclusion Criteria:\n\n* individuals 65 years of age or older with proximal humerus fractures\n\nExclusion Criteria:\n\n\\-","65 Years",{"count":57,"type":20},100,"INTERVENTIONAL",[60],"NA","Patients undergoing either operative or non-operative treatment of proximal humerus fractures will be studied with the goal of understanding which treatment modality provides optimal post-injury outcomes.",[25],[64,65,66,67,68,69,70,71],"proximal humerus fracture","humerus","fracture","shoulder","ORIF","IMN","nail","open reduction internal fixation","NOT_YET_RECRUITING","2025-10-15",{"date":75,"type":39},"2025-10-20",{"date":77,"type":20},"2026-09-01",{"date":79,"type":20},"2028-07-01",{"name":81,"class":82},"University of Massachusetts, Worcester","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":58,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100406408","impact-of-mobile-health-technology-application-on-proximal-humerus-fracture-care-practice-100406408","NCT04572022","Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice","Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice and Patient Self-Care Outcomes - A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Trauma associated proximal humerus fractures, presented at orthopaedic inpatient and outpatient units at Aga Khan University Hospital.\n* Patient and\u002For their care providers are voluntarily willing to follow the rehabilitation instructions via mobile application at home until completion of study follow up visits.\n* Patient agree to participate in very small survey questionnaire in the end of study.\n\nExclusion Criteria:\n\n* Patients who in special circumstances requiring special care and handling by expert health care providers.\n* Patient not willing to participate\u002Fexercise at home without physiotherapist support or to participate in survey questionnaire.\n* Patients who does not have facility of classic blue tooth connectivity for video download.","58 Years",{"count":93,"type":20},60,[60],"Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers.\n\nOur aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement.\n\nHypothesis:\n\nMobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales.\n\nObjectives:\n\nPrimary objective:\n\n1. To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app.\n2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care.\n\nSecondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application.\n\nMethods:\n\nStudy design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial.\n\nTotal 60 subjects required with 30 in each arm in 24-month duration.\n\nStudy procedures:\n\n1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents\u002Fsurgeon.\n2. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded.\n3. Written informed consent will be administered the study subjects as per GCP guideline.\n4. Each eligible patient will be randomized into intervention or control group.\n\n   1. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively.\n   2. Control group: Routine care will be provided to control group and as per routine.\n5. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score.\n6. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone.\n7. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes.\n8. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes.\n9. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious\u002FAdverse event (SAE\u002FAE), any patient who experience SAE\u002FAE, will receive good clinical care at earliest and all relevant reporting bodies will be notified.\n10. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years.\n\nStatistical Consideration:\n\nQuantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs\u002FSAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%.\n\nPatient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.",[25,97],"Trauma",[25,99,100,101],"mobile Health application","rehabilitation exercises","patient teaching video modules","2025-09-30",{"date":104,"type":39},"2025-10-01",{"date":106,"type":20},"2026-12",{"date":108,"type":20},"2027-12",{"name":110,"class":82},"Aga Khan University Hospital, Pakistan",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":83},"100466237","pmcf-study-on-the-safety-performance-and-clinical-benefits-data-of-the-anatomical-shoulder-20-fracture-system-100466237","NCT05351112","PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System","Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study","Inclusion Criteria:\n\n* Patients 18 years or older and skeletally mature\n* Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study\n* Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:\n\n  1. Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment\n  2. Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment\n  3. Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment\n  4. Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus\n  5. Posttraumatic necrosis of the humeral head\n  6. Posttraumatic arthrosis after humeral head fracture\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and\u002For to comply with the follow-up program.\n* The patient is known to be pregnant or breastfeeding\n* Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.\n* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).\n* Patients with plans to relocate during the study follow-up period\n* Signs of infection\n* Extensive stiffening of the shoulder joint without pain",{"count":119,"type":20},78,"The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.\n\nThe secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.",[25,122,123],"Posttraumatic Arthrosis After Humeral Head Fracture","Posttraumatic Necrosis of the Humeral Head",[125,126,127,128,129],"Post-Market Clinical Follow-Up Study","Medical Device","Performance","Safety","Clinical Benefits","2025-08-12",{"date":132,"type":39},"2025-08-17",{"date":134,"type":39},"2022-07-07",{"date":136,"type":20},"2034-01-21",{"name":138,"class":46},"Zimmer Biomet",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":16,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":58,"phases":151,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":83},"100370693","two--part-proximal-humerus---conservative-vs-operative-100370693","NCT04106674","Two- Part Proximal Humerus - Conservative vs Operative","Conservative Versus Operative Treatment of Two - Part Proximal Humerus Fractures","-The study-design is a single center single blinded randomized controlled trial (RCT) with 3 arms. Patients admitted to Akershus University Hospital with a displaced 2-part proximal humeral fracture of OTA\u002F AO group 11A2 or 11A3 in need of surgical treatment will be randomly allocated to two groups; conservative\u002F non-operative treatment or open reduction and internal fixation (ORIF). The patients allocated to ORIF will be randomly allocated to either the Philos plate (Synthes) or the Multiloc nail (Synthes).\n\nInclusion criteria\n\n1. Patients \\> 60 years and \\\u003C85 years\n2. More than 50% displacement between head or shaft or 50⁰ angulation of the head against the shaft in Y-projection or more than 45 ˚ valgus or more than 30˚ varus of the Head Shaft Angle (HSA).\n3. Patient with tuberculum majus or minor fractures which displaced \\\u003C5mm can be included as long as points 1 and 2 above are fulfilled.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Fracture more than 3 weeks old\n* No contact btw head and shaft\n* Ipsilateral damage that will influence the recovery and scoring systems\n* Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. This is up to the treating surgeon to decide\n* Pathological fracture or previous fracture of the same proximal humerus\n* Multitrauma or \"multifractured patient\"\n* Neurovascular injury\n* Open fracture\n* Noncompliance, dementia and\u002F or institutionalized\n* Congenital anomaly\n* Ongoing infectious process around the incision site for osteosynthesis\n* Systemic disease that may influence healing processes or scoring systems (in example Rheumatoid arthritis\u002FMultiple sclerosis\u002F poorly controlled DM)\n* Fracture dislocation\n* Substance abuse\n* Inability to read and understand Norwegian\n* Patients not residing in our catchment area\n* Patients with a diameter of the humerus to small for nailing, will be allocated to the Philos-group.\n* Any medical condition that excludes surgical treatment, including patients with ASA 3 or 4 that are considered too ill to go through surgery.",true,"60 Years","85 Years",{"count":150,"type":20},50,[60],"The proximal humerus fracture (PHFs) is the third most common fracture type in the elderly, and represents 5% of the overall fractures. The incidence is increasing. The purpose of the project is to compare surgical and conservative management of two- part PHFs in light of radiological, economical and clinical outcome. Do the participants between 60 and 85 years of age with displaced two-part PHFs fare better or worse after surgery compared to non-operative treatment?",[25,154],"2 Part Fracture",[156,157,158,159],"Proximal humerus fracture","Non-operative versus operative treatment","Conservative versus surgical treatment","Surgical versus non-surgical treatment","2022-10-24",{"date":162,"type":39},"2022-10-25",{"date":164,"type":39},"2020-10-01",{"date":166,"type":20},"2034-10-31",{"name":168,"class":82},"University Hospital, Akershus"]