Avascular Necrosis Clinical Trial
Official title:
Clinical and Radiological Outcomes of Medacta Shoulder System
NCT number | NCT05926622 |
Other study ID # | P06.001.03 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2022 |
Est. completion date | March 2037 |
This is a post-marketing surveillance on Medacta Shoulder System
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 2037 |
Est. primary completion date | March 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients older than 18 years - Patient with one of the following diagnosis: Primary osteoarthritis Secondary osteoarthritis Cuff tear arthropathy; insufficient rotator cuff Acute fracture (<21d) Rheumatoid or inflammatory arthritis Avascular necrosis Other posttraumatic condition Revision of shoulder arthroplasty Exclusion Criteria: - Patients with malignant diseases (at the time of surgery) - Patients with proven or suspect infections (at the time of surgery) - Patients with functional deficits other than dysfunction of the shoulder (at the time of surgery) - Patients with known incompatibility or allergy to products materials (at the time of surgery) |
Country | Name | City | State |
---|---|---|---|
France | Clinique Générale Annecy | Annecy |
Lead Sponsor | Collaborator |
---|---|
Medacta International SA |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival Rate | Kaplan Meier method | 10 years | |
Secondary | Clinical outcome evaluating Constant & Murley Score | Constant & Murley Score (CMS): The CMS is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively | 1, 2, 5 and 10 years | |
Secondary | Functional outcome evaluating Oxford Shoulder Score | Oxford Shoulder Score (OSS): The Oxford Shoulder Score is a unidimensional score comprising 12 questions. Starting with 1 (best/fewest symptoms) to 5 (worst/most severe) which is awarded to correspond to the patient's symptoms. The total gives a minimum score of 12 and a maximum of 60. A higher score implies a greater degree of disability. | 1, 2, 5 and 10 years | |
Secondary | Radiographic performance of the implants evaluating presence of radiolucencies | presence of radiolucencies | 3 months, 1, 2, 5 and 10 years | |
Secondary | Patient evaluation quality of life | EQ-5D-5L: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Typically it is calculated by assigning a numerical value to each response level (i.e., 1 for "no problems", 5 for "extreme problems"/"unable to") and summing these values across the five items, resulting in a score from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions) | 1, 2, 5 and 10 years | |
Secondary | Adverse events | record of adverse event | up to 10 years |
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