Comparison of Lateralized RTSA With and Without Subscapularis Repair

NCT04728282 | Recruiting

• 1 other identifier: RSASUB-16-01-2021
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.

Conditions

Arthritis Shoulder

Keywords

reverse total shoulder arthroplasty; subscapularis; repair

Outcome Measures

Primary Outcomes (1)

• ASES Score

  The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.

  24 months post-operative

Secondary Outcomes (29)

• Constant Score

  baseline pre-operative

• Constant Score

  3 months post-operative

• Constant Score

  6 months post-operative

• Constant Score

  12 months post-operative

• Constant Score

  24 months post-operative

Study Arms (2)

RTSA with subscapularis repair

EXPERIMENTAL

Procedure: RTSA with subscapularis repair

RTSA without subscapularis repair

ACTIVE COMPARATOR

Procedure: RTSA without subscapularis repair

Interventions

RTSA with subscapularis repair PROCEDURE

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

RTSA with subscapularis repair

RTSA without subscapularis repair PROCEDURE

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

RTSA without subscapularis repair

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
• First RTSA implantation
• Absence of neoplastic diseases at the treated site
• Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier \< Grade 3) based on pre-operative CT performed as standard of care in the patient group

You may not qualify if:

• Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
• Avascular necrosis
• Post-infectious arthritis
• Proximal humerus fracture
• Inflammatory arthritis
• Inability to communicate in English
• Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)
• Subscapularis with fatty infiltration (Goutallier ≥ 3)
• Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
• Any anatomical or patient characteristic that warrants a non-lateralized implant

Sponsors & Collaborators

• Panam Clinic: lead
• University of Manitoba: collaborator

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

RECRUITING

Study Officials

• Jarret Woodmass, MD

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila McRae, PhD

CONTACT

204-925-7469; smcrae@panamclinic.com

Derek McLennan, BSc

CONTACT

204-927-2828; dmclennan@panamclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double-blinded randomized clinical trial comparing two groups, RTSA with and RTSA without subscapularis repair. Eighty-four participants will be randomized at a 1:1 ratio in blocks of 12. All participants will be recruited from the patient populations of six fellowship trained upper extremity orthopaedic surgeons at initial consult. Patients will be randomized intraoperatively using a telephone/web-based system.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 28, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CA (1)