Rotator Cuff Tear Clinical Trial
Official title:
Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
Verified date | June 2011 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
Status | Completed |
Enrollment | 37 |
Est. completion date | October 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Any patient that is a candidate for reverse shoulder arthroplasty this includes: - rotator cuff tear arthroplasty, - irreparable rotator cuff tear, - significant proximal humerus fracture and malunions, - chronic proximal humerus dislocation. Exclusion Criteria: 1. Any patient with previous arthroplasty on affected shoulder. 2. Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer. 3. Patients who do not want to participate or participate in follow-ups. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Health Care Dept. of Orthopaedic Surgery | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty | We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind. | 36 Months | No |
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