Subscap Reverse Shoulder Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 95 years old

Undergoing reverse shoulder arthroplasty for any indication including revision surgery

Disqualifiers

Irreparable Subscapularis Tendon

Any history of proximal humerus fracture

Any revision with proximal humerus bone loss

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subscap Tenotomy

    Procedure/Surgery

    Group will not have their subscapularis tendon repaired following a reverse shoulder replacement.

  • Subscap Repair

    Procedure/Surgery

    Group will have their subscapularis tendon repaired following a reverse shoulder replacement.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Subscap TenotomyExperimental treatment 1 intervention
Group B: Subscap RepairExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Internal Rotation

Internal rotation behind the back

Time frame
Pre-op and post-op Months 3,6,12,24
2

Change in BOSS Scores

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.

Time frame
Pre-op and post-op Months 3,6,12,24

Secondary outcomes

1

Change in ASES score

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.

Time frame
Pre-op and post-op Months 3,6,12,24

Other outcomes

1

Ultrasound Evaluation

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

Time frame
Month 6

Sponsors and contacts

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