N/A
N=113
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
Glenohumeral Joint Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02768597 ↗Enrolled (actual)
113
Serious AEs
4.4%
Results posted
Feb 2024
Primary outcome: Primary: Active Forward Elevation of the Shoulder — 146; 141; 143; 137 degrees of movement — p=.552
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReUnion System with a Large-Diameter Glenosphere +2 mm offset (Device); ReUnion System with a Small-Diameter Glenosphere +2 mm offset (Device); ReUnion System with a Large-Diameter Glenosphere +6 mm offset (Device); ReUnion System with a Small-Diameter Glenosphere +6 mm offset (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Active Forward Elevation of the Shoulder |
146; 141; 143; 137 | .552 |
| PRIMARY Active External Rotation of the Shoulder |
55; 60; 52; 54 | .558 |
| PRIMARY Shoulder Abduction Strength |
4.8; 4.5; 4.7; 4.8 | .274 |
| PRIMARY Shoulder External Rotation Strength |
4.8; 4.6; 4.7; 4.7 | .539 |
| PRIMARY Shoulder Internal Rotation Strength |
4.9; 4.8; 4.7; 4.9 | .478 |
| SECONDARY Oxford Shoulder Score (OSS) Questionnaire |
6.8; 4.2; 11.0; 0.7 | .527 |
| SECONDARY American Shoulder and Elbow Surgeons (ASES) Questionnaire |
50.7; 46.7; 56.8; 56.4 | .823 |
| SECONDARY Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire |
9.7; 9.1; 9.3; 8.3 | .231 |
| SECONDARY Shoulder Pain |
0.3; 0.5; 0.3; 0.3 | .595 |
| SECONDARY Patient Satisfaction |
9.6; 9.4; 9.2; 9.4 | .789 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02768597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.