Lesser Tuberosity Osteotomy for Subscapularis Repair

NCT02762903 | Completed Results

• 1 other identifier: AAAE1446
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Shoulder arthroplasty; Lesser Tuberosity Osteotomy; Subscapularis tenotomy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Radiologic Evidence of Anatomic Healing

  Tendon healing/tuberosity union based on radiographs

  Post operative at 1 year

Secondary Outcomes (5)

• Mean Visual Analogue Pain Scale (VAS)

  1 year post-operatively

• Forward Elevation (FE) Strength

  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

• External Rotation (ER) Strength

  1 year post-operatively

Study Arms (2)

Tenotomy

ACTIVE COMPARATOR

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with tenotomy technique.

Procedure: TSA with tenotomy technique; Device: Shoulder prosthesis

Osteotomy

ACTIVE COMPARATOR

Subjects will receive shoulder prosthesis for subscapularis repair during TSA with lesser tuberosity osteotomy technique.

Procedure: TSA with lesser tuberosity osteotomy technique; Device: Shoulder prosthesis

Interventions

TSA with tenotomy technique PROCEDURE

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.

Tenotomy

TSA with lesser tuberosity osteotomy technique PROCEDURE

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.

Osteotomy

Shoulder prosthesis DEVICE

Standard procedure: Total shoulder arthroplasty replaces both components of the "ball and socket" joint with a metal device.

Osteotomy; Tenotomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients already scheduled for total shoulder arthroplasty

You may not qualify if:

• Unable to provide information throughout postoperative recovery and attend subsequent office visits thereafter (a minimum of one year).

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 30771825 RESULT

MeSH Terms

Conditions

Osteoarthritis

Interventions

theasinensin A; Shoulder Prosthesis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Joint Prosthesis; Prostheses and Implants; Equipment and Supplies

Limitations and Caveats

The standard deviation for Outcome Measure #2,4,5 was not calculated. Raw data existed during the study period of 2009 to 2013. This record was completed and published in 2016 without results. The data was subsequently destroyed because the data retention period had ended. This study closed with the IRB in 2017 and further analysis cannot be conducted. As of the current year, 2024, all the raw data for this study no longer exists. The standard deviation cannot be calculated without the raw data.

Results Point of Contact

• Title: William N. Levine, MD
• Organization: Columbia University

wnl1@cumc.columbia.edu

212-305-0998

Study Officials

• William N. Levine, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 5, 2016
• Study Start: August 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)