Clinical and Radiological Outcomes of Medacta Shoulder System FR
Study Details
Study Description
Brief Summary
This is a post-marketing surveillance on Medacta Shoulder System
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Survival Rate [10 years]
Kaplan Meier method
Secondary Outcome Measures
- Clinical outcome evaluating Constant & Murley Score [1, 2, 5 and 10 years]
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
- Functional outcome evaluating Oxford Shoulder Score [1, 2, 5 and 10 years]
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.
- Radiographic performance of the implants evaluating presence of radiolucencies [3 months, 1, 2, 5 and 10 years]
presence of radiolucencies
- Patient evaluation quality of life [1, 2, 5 and 10 years]
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)
- Adverse events [up to 10 years]
record of adverse event
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique Générale Annecy | Annecy | France | 74000 |
Sponsors and Collaborators
- Medacta International SA
Investigators
- Principal Investigator: Bruno Toussaint, Clinique Générale Annecy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P06.001.03