Lesser Tuberosity Osteotomy for Subscapularis Repair

Osteoarthritis Clinical Trial

Official title:

Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762903
• Other study ID #: AAAE1446
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: May 3, 2016
• Start date: August 2009
• Est. completion date: June 2013

Study information

• Verified date: May 2016
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with radiologic evidence of anatomic healing	Tendon healing/tuberosity union based on radiographs	Post operative at 3 months	No
Secondary	Change in visual analogue pain scale	Pain indication measurement where 0 indicates no pain and 10 indicates worst possible pain	Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year	No
Secondary	Change in dynamometer maximum exertion reading	Strength testing with Dynamometer in forward Flexion, abduction, external rotation and internal rotation using force measurement at max level.	Post operative clinic visits at 3 weeks, 3 months, 6 months, and 1 year	No
Secondary	Total Intra-Operative time	To be recorded in minutes, and documented by the surgical team	From incision time to time of complete skin closure	No
Secondary	Total Subscapularis Repair time (in minutes)	To be recorded in minutes, and documented by the surgical team	From glenoid implantation to completion of tendon or osteotomy repair	No