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New treatment option for Arthritis Shoulder
Official title Comparison of Lateralized RTSA With and Without Subscapularis Repair
ClinicalTrials.gov ID: NCT04728282
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to...
- 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...
You likely can't join if
- Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
- Inability to communicate in English
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Winnipeg, Manitoba, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.