Joint; Destruction, Sacroiliac, Osteomalacia, Osteoporosis, Rotator Cuff Tear Arthropathy
Conditions
Brief summary
Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
Detailed description
The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes including adverse events, scapular notching, and Constant Score. All shoulders on which data will be collected are legally marketed and none of the devices are investigational or experimental. FDA has cleared this device via Premarket Notification 510(k) K080642. This data collection effort will document the clinical outcomes of the Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Interventions
DEVICECOMPREHENSIVE
Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients / cases to be included in this study shall utilize the following inclusion criteria: 1. Comprehensive Reverse Shoulder Mini Base Plate and Mini Stem in a reverse shoulder configuration. 2. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. 3. Grossly deficient rotator cuff with severe arthropathy and/or 1. Previously failed shoulder joint replacement with a grossly deficient rotator cuff. 2. Primary total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 3. Fracture total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, or 4. Revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship | 1 year | The primary objective of this prospective clinical data collection is to evaluate survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (including dislocation) | 3 year | Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes |
| Constant-Murley Shoulder Score | 3 year | Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes |
| Radiographic Evaluation (Plain X-ray and CT) | 3 year | Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes |
| Scapular Notching | 3 year | Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes |
| Radiographic Evaluation | 1 year | Secondary objectives include validation of implant sizing and hardware options as well as collection of mid-term clinical outcomes |
Countries
South Korea
Outcome results
None listed