Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty

Mayo Clinic

Status: Completed

Conditions: Glenohumeral Joint Degeneration

Treatments: Device: 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 Small-Diameter Glenosphere +6 mm offset; Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offset

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02768597

15-006839

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 4 patient groups

Large-Diameter Glenosphere +2 mm offset

Active Comparator group

Description:

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset

Treatment:

Device: ReUnion System with a Large-Diameter Glenosphere +2 mm offset

Small-Diameter Glenosphere +2 mm offset

Active Comparator group

Description:

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset

Treatment:

Device: ReUnion System with a Small-Diameter Glenosphere +2 mm offset

Large-Diameter Glenosphere +6 mm offset

Active Comparator group

Description:

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset

Treatment:

Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offset

Small-Diameter Glenosphere +6 mm offset

Active Comparator group

Description:

Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset

Treatment:

Device: ReUnion System with a Small-Diameter Glenosphere +6 mm offset