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Subscap Reverse Shoulder Arthroplasty

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05344898
Collaborator
(none)
118
Enrollment
2
Arms
60
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Subscap Tenotomy
  • Procedure: Subscap Repair
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Subscapularis Repair in Reverse Shoulder Arthroplasty: A Multi-Center Randomized Single Blinded Superiority Study
Anticipated Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
May 15, 2027
Anticipated Study Completion Date :
May 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subscap Tenotomy

Procedure: Subscap Tenotomy
Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.
Experimental: Subscap Repair

Procedure: Subscap Repair
Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

Outcome Measures

Primary Outcome Measures

  1. Change in Internal Rotation [Pre-op and post-op Months 3,6,12,24]

    Internal rotation behind the back

  2. Change in BOSS Scores [Pre-op and post-op Months 3,6,12,24]

    Change in Baltimore Orthopaedic Subscapularis Score (BOSS) over 2 years. The score asks enrolled patients a series of questions. The answer choices are the following: No difficulty, mild difficulty, severe difficulty, unable to perform.

Secondary Outcome Measures

  1. Change in ASES score [Pre-op and post-op Months 3,6,12,24]

    Change in American Shoulder and Elbow Surgeon (ASES) score over 2 years postoperatively compared to preoperative. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain possible.

Other Outcome Measures

  1. Ultrasound Evaluation [Month 6]

    Blinded ultrasound evaluation of subscapularis integrity at 6 months. The "Sugaya classification" will be used to assess the subscapularis integrity. The score ranges from Type 1 to Type 5. Type 1: indicating sufficient thickness with homogeneously low intensity Type 2: sufficient thickness with partial high intensity Type 3: insufficient thickness without discontinuity Type 4: the presence of a minor discontinuity Type 5: the presence of a major discontinuity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. 18 to 95 years old

  2. Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Exclusion Criteria:
  1. Irreparable Subscapularis Tendon
  1. Reparability of Subscapularis will be determined based on MRI or CT scan obtained preoperatively and confirmed intraoperatively. Tendons must be intact with less than Grade I or II Fatty Infiltration as determined by the Goutallier classification.

  1. Any history of proximal humerus fracture

  2. Any revision with proximal humerus bone loss

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

  • Principal Investigator: Mohit Gilotra, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohit N. Gilotra, Associate Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT05344898
Other Study ID Numbers:
  • HP-00100825
First Posted:
Apr 25, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Wounds and Injuries
Rotator Cuff Injuries
Shoulder Injuries

Study Results

No Results Posted as of Apr 25, 2022