Subscapularis Repair in Reverse Shoulder Arthroplasty

Last updated: January 29, 2024
Sponsor: Arthrex, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Repair of the subscapularis

Clinical Study ID

NCT05438914
AIRR-00608-20
  • Ages 18-100
  • All Genders

Study Summary

This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using theArthrex ReversTM system.
  2. Patient voluntarily consents to participate in the study and has the mental andphysical ability to participate in the study, fill out subjective questionnaires,return for follow-up visits, and comply with prescribed post-operative physicaltherapy.
  3. Patient meets FDA cleared indications for reverse shoulder arthroplasty
  4. Patient is between 18-100 years old
  5. Patient agrees to also be enrolled in the Arthrex Total Shoulder Registry Study
  6. Patient has a standard of care pre-operative CT taken within 6 months that has beensubmitted for Arthrex Virtual Implant Positioning TM (VIP) planning

Exclusion

Exclusion Criteria:

  1. Patient has a history of ipsilateral shoulder arthroplasty
  2. A history of shoulder septic arthritis
  3. A full thickness subscapularis tear
  4. An acute or malunited proximal humeral fracture
  5. Chronic locked dislocation
  6. Rheumatoid arthritis
  7. Tumors
  8. Axillary nerve damage
  9. Non-functioning deltoid muscle
  10. Glenoid vault deficiency precluding baseplate fixation
  11. Infection and neuropathic joints
  12. Known or suspected non-compliance, drug or alcohol abuse
  13. Patients incapable of judgement or under tutelage
  14. Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, dementia, contraindication for imaging etc.
  15. The subject is related to investigator as family members, employees, or otherdependent persons
  16. Any prior open anterior shoulder surgery that included takedown of the subscapularistendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

Study Design

Total Participants: 134
Treatment Group(s): 1
Primary Treatment: Repair of the subscapularis
Phase:
Study Start date:
November 14, 2022
Estimated Completion Date:
September 14, 2025

Study Description

The primary objective of this study is to evaluate pain and function in patients undergoing RSA with or without subscapularis repair. This primary outcome will be measured by analysis of Constant scores at two years post-operative.

Secondary objectives are to evaluate pain, function and imaging, between the two groups at each applicable time point.

Connect with a study center

  • The University of Arizona/Banner Health

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Western Orthopaedics, P.C.

    Denver, Colorado 80218
    United States

    Site Not Available

  • Southern Oregon Orthopedics

    Medford, Oregon 97504
    United States

    Active - Recruiting

  • The Hawkins Foundation

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • The Campbell Clinic

    Collierville, Tennessee 38017
    United States

    Active - Recruiting

  • Jordan Young Institute

    Norfolk, Virginia 23462
    United States

    Active - Recruiting

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