Comparing shoulder surgery techniques for arthritis treatment
Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
This study is testing whether shoulder surgery for arthritis works better with or without a specific muscle repair to see how it affects patients' recovery and shoulder function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Panam Clinic Academic / other |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT04728282 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of reverse total shoulder arthroplasty (RTSA) with and without subscapularis repair in patients suffering from shoulder arthritis. It is a double-blind randomized controlled trial that will assess patient-reported outcomes, clinical measures, and functional performance over a 24-month postoperative period. The study will evaluate differences in PROM scores, shoulder function, dislocation rates, surgical complications, and operative times between the two surgical approaches.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with glenohumeral arthritis or related conditions who are undergoing their first RTSA.
Not a fit: Patients with previous shoulder surgeries, severe fatty infiltration of the subscapularis, or other specific shoulder conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and outcomes for patients undergoing shoulder surgery.
How similar studies have performed: Previous studies have shown varying outcomes with different surgical approaches in shoulder arthroplasty, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Winnipeg, Manitoba
- Pan Am Clinic — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Principal investigator: Jarret Woodmass, MD — Pan Am Clinic
- Study coordinator: Sheila McRae, PhD
- Email: smcrae@panamclinic.com
- Phone: 204-925-7469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.