Lesser Tuberosity Osteotomy for Subscapularis Repair
July 16, 2024 updated by: Columbia University
Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement.
The investigators hypothesize that participants who receive a newer repair technique called a lesser tuberosity osteotomy will have lower rates of postoperative subscapularis muscle dysfunction and rupture as compared to those who receive the traditional tenotomy repair.
Study Overview
Status
Completed
Conditions
Detailed Description
The subscapularis tendon is mobilized during total shoulder arthroplasty in order to gain anterior access to the glenohumeral joint.
Postoperative subscapularis dysfunction is being recognized more frequently and has been reported in >65% of patients following shoulder arthroplasty with a soft-tissue repair.
Subscapularis dysfunction has been associated with poor functional outcomes including tendon rupture and anterior instability, a major indication for revision surgery.
Recent studies suggest that a standard subscapularis tenotomy with primary tendon repair may lead to failure of the repair and decreased functional outcomes as compared to a more novel lesser tuberosity osteotomy technique.
The investigators study aims to validate the results of the current literature in a prospective randomized controlled trial, which to their knowledge has not been reported on this topic.Investigators will compare clinical outcomes following these two techniques during total shoulder arthroplasty.
Participants undergoing total shoulder replacement will be randomized to receive either a lesser tuberosity osteotomy or tenotomy with primary subscapularis tendon repair.
All other procedures conducted in this study are considered standard of care except for ultrasounds, which are conducted for research purposes in the subscapularis tenotomy group.
Postoperative outcomes will be monitored objectively and subjectively at routine postoperative office visits using physical exam, imaging (X-rays and ultrasounds), and questionnaires.
If the hypothesis is proven to be true, the investigators will establish gold-standard evidence for the use of the newer osteotomy technique to improve patient satisfaction and mobility following shoulder arthroplasty.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients already scheduled for total shoulder arthroplasty
Exclusion Criteria:
- Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tenotomy
Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.
|
Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA).
The subscapularis tendon is incised close to its attachment on the humerus.
The Tendon is repaired with sutures.
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
|
|
Active Comparator: Osteotomy
Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.
|
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA.
A small fleck of bone is removed from humerus, the subscapularis tendon is still attached.
The fleck of bone is reattached with sutures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Subjects With Radiologic Evidence of Anatomic Healing
Time Frame: Post operative at 1 year
|
Tendon healing/tuberosity union based on radiographs
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Post operative at 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Visual Analogue Pain Scale (VAS)
Time Frame: 1 year post-operatively
|
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain.
Mean score is reported without a range or standard deviation.
|
1 year post-operatively
|
|
Forward Elevation (FE) Strength
Time Frame: 1 year post-operatively
|
Strength testing with Dynamometer in forward elevation was conducted to determine the mean in FE strength.
|
1 year post-operatively
|
|
Total Intra-Operative Time
Time Frame: From incision time to time of complete skin closure
|
To be recorded in minutes, and documented by the surgical team
|
From incision time to time of complete skin closure
|
|
Total Subscapularis Repair Time (in Minutes)
Time Frame: From glenoid implantation to completion of tendon or osteotomy repair
|
To be recorded in minutes, and documented by the surgical team
|
From glenoid implantation to completion of tendon or osteotomy repair
|
|
External Rotation (ER) Strength
Time Frame: 1 year post-operatively
|
Strength testing with Dynamometer in external rotation.
|
1 year post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William N. Levine, MD, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (Estimated)
May 5, 2016
Study Record Updates
Last Update Posted (Actual)
August 6, 2024
Last Update Submitted That Met QC Criteria
July 16, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAE1446
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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