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โ† Trials
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Comparison of Lateralized RTSA With and Without Subscapularis Repair

RecruitingNAAges 18 Years - anyAllPanam Clinic
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • RTSA with subscapularis repair
  • RTSA without subscapularis repair
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Where

1 site
Pan Am Clinic
Winnipeg, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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