Anatomical Shoulder™ IR Study
This trial is active, not recruiting.
|Treatment||inverse/reverse shoulder arthroplasty|
|Start date||September 2005|
|End date||September 2023|
|Trial size||160 participants|
|Trial identifier||NCT02466321, 06-U02|
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
Outcome data will be collected using the following standard scoring systems of which summary statistics will be provided:
- Constant and Murley Score to evaluate clinical parameters such as range of motion, power, level of pain and functional ability.
- SF-12 Physical and Mental Health Summary Measures (SF12 Questionnaire) comprising of twelve questions to assess the subject's physical and mental health status which must be answered by the patient.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Antwerpen, Belgium||AZ Monica Antwerpen||no longer recruiting|
|Hamburg, Germany||HELIOS ENDO-Klinik Hamburg||no longer recruiting|
|Kassel, Germany||Vitos Orthopädische Klinik Kassel||no longer recruiting|
|Zürich, Switzerland||Uniklinik Balgrist||no longer recruiting|
|Manchester, United Kingdom||The Pennine Acute Hospital NHS Trust||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Patient treated with a inverse / reverse shoulder device.
time frame: 10 years
time frame: 10 years
Male or female participants at least 18 years old.
Inclusion Criteria: - Age - 18 years minimum. - Sex - male and female. - General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history. - Informed Consent - patient or patient's legal representative has signed a Patient Informed Consent form. - Indications - Diagnosis of disease or trauma in the affected joint, including cuff-tear arthropathy, failure of prior rotator cuff surgery and irreparable rotator cuff tears associated with loss of glenohumeral stability with the indication for total shoulder arthroplasty. - The deltoid muscle has to be intact in all 3 parts (clavicular, acromial as well as spinal). Exclusion Criteria: - Patient is skeletally immature. - Patient is pregnant. - Patient is unwilling or unable to cooperate in a follow-up program. - Patient shows one of the following medical conditions - Chronic fracture, Acute fracture, Axillary nerve lesion, Severe loss of humeral or glenoid bone, Paralysis of the deltoid muscle, Active Infection - Patient requires one of the following medical interventions - Implant Revision, Glenoid bone grafting, Autografts
|Official title||Anatomical Shoulder™ Inverse/Reverse Post-Market Surveillance Study|
|Description||This is a multi-centre, non-comparative, prospective post-market surveillance study involving orthopaedic surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder™ Inverse/Reverse implant. All system components are CE-marked and commercially available. Patients will be selected according to the subject selection criteria. All patients will undergo pre-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at either 6 weeks or 6 months (according to the hospital's standard care plan) and thereafter at 1, 2, 5 and 10 years post hospital discharge. There are 5 study centres taking part in this project enrolling in total a maximum of 160 patients.|
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