Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DePuy International | INDUSTRY |
| Johnson & Johnson | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | C.A.P |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humeral surface replacement hemiarthroplasty (CAP) | Device | C.A.P hemiarthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder And Elbow Surgeons Shoulder Index (ASES) | 24 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Score | 24 months post-operative | |
| Western Ontario Osteoarthritis of the Shoulder Index (WOOS) | 24 months post-operative | |
| Simple Shoulder Test (SST) |
Not provided
Pre-Operative Inclusion Criteria:
Pre-Operative Exclusion Criteria:
Intra-Operative Inclusion Criteria:
Advanced humeral head cartilage loss AND ONE of:
Intra-Operative Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Richard Boorman | University of Calgary | Principal Investigator |
| Dr. Dianne Bryant | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary Sport Medicine Centre | Calgary | Alberta | T2N 1N4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months post-operative |
| Radiographic Evaluation | 3 months + yearly post-operative |