Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | October 2014 |
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.
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.
The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical
challenge. The reverse prosthesis offers a treatment option for subset of patients as
previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have
provided sub-optimal clinical results. Numerous reports in the literature have validated the
effectiveness of the reverse design.
Patients meeting criteria must be between the ages of 50 and 95 years of age and are a
candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff
tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures
and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be
enrolled and randomized to either one of two groups; 20 patients will be randomized to the
Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset
design. Both implants are FDA approved. The patients will be followed for 24 months and will
follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires
will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24
months.
challenge. The reverse prosthesis offers a treatment option for subset of patients as
previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have
provided sub-optimal clinical results. Numerous reports in the literature have validated the
effectiveness of the reverse design.
Patients meeting criteria must be between the ages of 50 and 95 years of age and are a
candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff
tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures
and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be
enrolled and randomized to either one of two groups; 20 patients will be randomized to the
Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset
design. Both implants are FDA approved. The patients will be followed for 24 months and will
follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires
will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24
months.
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.
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