Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Columbia University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Radiologic Evidence of Anatomic Healing
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility 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).
Outcomes
Primary Outcomes
Number of Subjects With Radiologic Evidence of Anatomic Healing
Time Frame: Post operative at 1 year
Tendon healing/tuberosity union based on radiographs
Secondary Outcomes
- Mean Visual Analogue Pain Scale (VAS)(1 year post-operatively)
- Total Intra-Operative Time(From incision time to time of complete skin closure)
- Total Subscapularis Repair Time (in Minutes)(From glenoid implantation to completion of tendon or osteotomy repair)
- Forward Elevation (FE) Strength(1 year post-operatively)
- External Rotation (ER) Strength(1 year post-operatively)