Status:
RECRUITING
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Lead Sponsor:
Panam Clinic
Collaborating Sponsors:
University of Manitoba
Conditions:
Arthritis Shoulder
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 p...
Detailed Description
The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
- Intra-operative Exclusions:
- 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
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04728282
Start Date
November 1 2021
End Date
May 1 2027
Last Update
April 2 2024
Active Locations (1)
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1
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4