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Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
The aim of this study is to collect immediate medium and long term data on performance and safety of the implant, retrospectively as well as prospectively, from a consecutive series of patients to assess the patients' outcomes and functional status.
Resurfacing head implants allow restoring of the normal joint mechanics and stability of the shoulder with minimal bone resection and low peripheral fracture risk, while preserving humeral bone stock. Non cemented head implants also allow for an easy re-intervention if needed. The success of resurfacing implants largely depends on the etiology, with the best results in primary shoulder arthrosis, and the worst in post-traumatic and cuff-tear arthropathy.
The Aequalis® Resurfacing Humeral Head is designed to restore the humeral head. It shares the same indications as shoulder arthroplasty in general, including the various types of arthritis and conditions resulting in loss of joint cartilage, joint incongruity, pain, and stiffness. Resurfacing humeral head implants allow minimal bone resection while preserving humeral bone stock as compared to standard anatomic humeral implants.
However, few data are available on mid-term effects of the resurfacing head implant developed by Tornier. This Post-Marketing study is implemented for the Aequalis® Resurfacing Head in shoulder arthroplasty to collect medium and long-term clinical data on performance and safety. It is designed to collect data from consecutive series in European patients for at least 12 months of follow-up and up to 10 years. If possible, the study duration and collection of information will be prolonged. Further follow-up can be implemented, by amendments.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shoulder hemi-arthroplasty | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Implant survival rate | Number or device or procedure related adverse events | up to 10-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline and previous visit in Constant Murley score | at 3-month, 1, 2, 5, 10 years follow-up | |
| Change from baseline and previous visit in Range Of Motion | Passive and active Abduction, external rotation and internal rotation will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Timely evaluation of fixation and migration of the implant. | Presence of radiolucent line(s) around the implant (Radiological imaging : X-Rays of MRI). | at 3-month, 1, 2, 5, 10 years follow-up |
| Timely evaluation of glenoid status. |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be selected from 6 centers in Europe where shoulder arthroplasty with Aequalis® Resurfacing Head is performed.
The first 100 patients treated in the centers will be included then followed-up, until the 10 years follow-up visit.
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| Name | Affiliation | Role |
|---|---|---|
| Lionel NEYTON, MD | Centre Orthopédique Santy, Lyon, FR | Principal Investigator |
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| at 3-month, 1, 2, 5, 10 years follow-up |
| Change from baseline and previous visit in SSV. | The Subjective Shoulder Value (SSV) is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. | at 3-month, 1, 2, 5, 10 years follow-up |
Radiological imaging (X-Rays or MRI).
| at 3-month, 1, 2, 5, 10 years follow-up |