Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 50 - 90 |
| Updated: | 5/14/2016 |
| Start Date: | April 2016 |
| End Date: | February 2022 |
| Contact: | Teron Cox |
| Email: | cox.teron@mayo.edu |
| Phone: | (507) 538-3560 |
A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
The study will compare the outcome of primary reverse shoulder arthroplasty using the
Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm)
glenosphere with either a +2 mm or a +6 mm offset.
Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm)
glenosphere with either a +2 mm or a +6 mm offset.
A total of 220 shoulders will be included in the study (55 shoulders in each of the four
groups). Each shoulder will be assessed preoperatively, at 3 weeks, 3 months, one year, two
years and five years. The primary end-point will be range of motion at one year. Additional
end-points will include dislocation, stress fractures of the acromion, metal ion levels in
peripheral blood, neurovascular complications, radiographic notching, implant mechanical
failure and revision surgery.
groups). Each shoulder will be assessed preoperatively, at 3 weeks, 3 months, one year, two
years and five years. The primary end-point will be range of motion at one year. Additional
end-points will include dislocation, stress fractures of the acromion, metal ion levels in
peripheral blood, neurovascular complications, radiographic notching, implant mechanical
failure and revision surgery.
Inclusion Criteria:
- Subjects willing to sign the informed consent
- Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
- Subjects requiring a primary reverse total shoulder arthroplasty
- Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable
rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or
bone loss
Exclusion Criteria:
- Inability to comply with follow-up requirements
- Subjects with inflammatory arthritis
- Subjects with proximal humerus fractures
- Subjects with sequels of trauma
- Subjects that are immunologically compromised
- Subjects with an active or suspected latent infection in or about the shoulder
- Need to add a tendon transfer
- Need for structural humeral bone graft
- Pregnant subjects
We found this trial at
1
site
Click here to add this to my saved trials
