A Study Comparing the Outcome of a Large-Diameter versus Small-Diameter Glenosphere (Shoulder/Arm Ball-Joint) in Primary Reverse Shoulder Arthroplasty

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-006839
    NCT ID: NCT02768597
    Sponsor Protocol Number: 15-006839

About this study

The purpose of this study is to compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with the implantation of either a large (40 mm) or a small (36 mm) glenosphere (shoulder to arm, ball shaped joint).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Willing to sign the informed consent
  • Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
  • Require a primary reverse total shoulder arthroplasty
  • Have 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
  • Have inflammatory arthritis
  • Have proximal humerus fractures
  • Have sequels of trauma
  • Are immunologically compromised
  • Have an active or suspected latent infection in or about the shoulder
  • Need to add a tendon transfer
  • Need a structural humeral bone graft
  • Are pregnant

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Morrey, M.D.

Open for enrollment

Contact information:

Teron Cox CCRP

(507)538-3560

Cox.Teron@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20204263

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