Recruiting NCT05926622
Clinical and Radiological Outcomes of Medacta Shoulder System FR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Radiological Outcomes of Medacta Shoulder System
Overview
This is a post-marketing surveillance on Medacta Shoulder System
Primary outcome measures
- Survival Rate [Time frame: 10 years]
Secondary outcome measures (5)
- Clinical outcome evaluating Constant & Murley Score [Time frame: 1, 2, 5 and 10 years]
- Functional outcome evaluating Oxford Shoulder Score [Time frame: 1, 2, 5 and 10 years]
- Radiographic performance of the implants evaluating presence of radiolucencies [Time frame: 3 months, 1, 2, 5 and 10 years]
- Patient evaluation quality of life [Time frame: 1, 2, 5 and 10 years]
- Adverse events [Time frame: up to 10 years]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Clinique Générale Annecy — Annecy
Identifiers
NCT: NCT05926622 · P06.001.03