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

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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