Recruiting

Reverse Shoulder Arthroplasty

Sponsor:

Arthrex, Inc.

Code:

NCT05438914

Conditions

Rotator Cuff Tear Arthropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Repair of the subscapularis

Study Details

Brief summary:

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

Conditions

Rotator Cuff Tear Arthropathy

Study ID

NCT05438914

Start date

Nov 14, 2022

Status verified date

Jan, 2024

Completion date

Sep 14, 2025

Anticipated

Primary completion date

Sep 14, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient is scheduled to undergo a reverse shoulder arthroplasty procedure using the Arthrex ReversTM system.
2. Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
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 been submitted for Arthrex Virtual Implant Positioning TM (VIP) planning

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 other dependent persons
16. Any prior open anterior shoulder surgery that included takedown of the subscapularis tendon or violation of the subscapularis tendon (i.e. Latarjet, Bristow)

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Reverse Shoulder Arthroplasty with subscapularis repair

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

no intervention: Reverse Shoulder Arthroplasty without subscapularis repair

The subscapularis will not be repaired.

Interventions

Repair of the subscapularis

The subscapularis will be repaired using the "suture through bone and prosthesis holes" surgical technique.

Primary outcome measure

  • Constant-Murley Shoulder Outcome Score [ Time Frame: Collected at at pre-op, but the primary outcome is the score at 2 years post-procedure. ]
  • Constant-Murley Shoulder Outcome Score [ Time Frame: Collected at at 9 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure. ]
  • Constant-Murley Shoulder Outcome Score [ Time Frame: Collected at at the 26 week post-op timepoint, but the primary outcome is the score at 2 years post-procedure. ]
  • Constant-Murley Shoulder Outcome Score [ Time Frame: Collected at at 1 year post-op timepoint, but the primary outcome is the score at 2 years post-procedure. ]
  • Constant-Murley Shoulder Outcome Score [ Time Frame: Collected at the 2 year post-op timepoint, and is the primary outcome measure ]

Central Contacts and Locations

Locations

The University of Arizona/Banner Health

Recruiting

Phoenix, Arizona, United States, 85006

Southern Oregon Orthopedics

Recruiting

Medford, Oregon, United States, 97504

The Hawkins Foundation

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Sam Pergiovanni

888-666-2904

Principal Investigator:

Michael Kissenberth, MD

The Campbell Clinic

Recruiting

Collierville, Tennessee, United States, 38017

Jordan Young Institute

Recruiting

Norfolk, Virginia, United States, 23462

More Information

Sponsor

Arthrex, Inc.

Last update posted

Jan 30, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arthrex, Inc. on 2024-01-30.