Clinical trial NCT02762903: Lesser Tuberosity Osteotomy for Subscapularis Repair
Official title: Lesser Tuberosity Osteotomy Versus Tenotomy for Subscapularis Repair During Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Shoulder arthroplasty
Lesser Tuberosity Osteotomy
Subscapularis tenotomy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Number of Subjects With Radiologic Evidence of Anatomic Healing
timeFrame: Post operative at 1 year
Secondary outcomes:
measure: Mean Visual Analogue Pain Scale (VAS)
timeFrame: 1 year post-operatively
measure: Forward Elevation (FE) Strength
timeFrame: 1 year post-operatively
measure: Total Intra-Operative Time
timeFrame: From incision time to time of complete skin closure
measure: Total Subscapularis Repair Time (in Minutes)
timeFrame: From glenoid implantation to completion of tendon or osteotomy repair
measure: External Rotation (ER) Strength
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: William N. Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine WN, Munoz J, Hsu S, Byram IR, Bigliani LU, Ahmad CS, Kongmalai P, Shillingford JN. Subscapularis tenotomy versus lesser tuberosity osteotomy during total shoulder arthroplasty for primary osteoarthritis: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2019 Mar;28(3):407-414. doi: 10.1016/j.jse.2018.11.057.