Lesser Tuberosity Osteotomy for Subscapularis Repair
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tenotomy Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique. |
Procedure: 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.
Device: Shoulder prosthesis
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. |
Procedure: TSA with lesser tuberosity osteotomy technique
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.
Device: Shoulder prosthesis
Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with radiologic evidence of anatomic healing [Post operative at 3 months]
Tendon healing/tuberosity union based on radiographs
Secondary Outcome Measures
- Change in visual analogue pain scale [Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year]
Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain
- Change in dynamometer maximum exertion reading [Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year]
Strength testing with Dynamometer in forward Flexion, abduction, external rotation and internal rotation using force measurement at max level.
- Total Intra-Operative time [From incision time to time of complete skin closure]
To be recorded in minutes, and documented by the surgical team
- Total Subscapularis Repair time (in minutes) [From glenoid implantation to completion of tendon or osteotomy repair]
To be recorded in minutes, and documented by the surgical team
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: William N. Levine, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAE1446