A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Shoulder Abduction Strength
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Intervention: ReUnion System with a Large-Diameter Glenosphere +2 mm offset (Device)
Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Intervention: ReUnion System with a Small-Diameter Glenosphere +2 mm offset (Device)
Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Intervention: ReUnion System with a Large-Diameter Glenosphere +6 mm offset (Device)
Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Intervention: ReUnion System with a Small-Diameter Glenosphere +6 mm offset (Device)
Outcomes
Primary Outcomes
Shoulder Abduction Strength
Time Frame: one year
Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Active Forward Elevation of the Shoulder
Time Frame: One year
Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.
Active External Rotation of the Shoulder
Time Frame: One year
Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.
Shoulder External Rotation Strength
Time Frame: One year
Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Shoulder Internal Rotation Strength
Time Frame: One year
Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Secondary Outcomes
- Patient Satisfaction(One year)
- Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire(One year)
- Shoulder Pain(One year)
- American Shoulder and Elbow Surgeons (ASES) Questionnaire(One year)
- Oxford Shoulder Score (OSS) Questionnaire(1 year)
Investigators
Mark E. Morrey, M.D.
Principal Investigator
Mayo Clinic