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Compares treatment options for Rotator Cuff Tears
Official title Lower Trapezius Transfer vs Bridging Reconstruction
ClinicalTrials.gov ID: NCT05925881
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. The main questions it aims to answer are: comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.
- 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
- magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
- tear size \>5cm
- two-tendon, irreparable tear
- competent adult (\>18 years of age)
- \<50% muscle atrophy.
You likely can't join if
- irreparable subscapular tear
- glenohumeral osteoarthritis
- WORC score \> 70
- uncontrolled diabetes (Hgb A1C \>7%)
- pregnancy
- presence of local or systemic infection
See the full eligibility criteria
- magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
- tear size \>5cm
- two-tendon, irreparable tear
- competent adult (\>18 years of age)
- \<50% muscle atrophy.
- irreparable subscapular tear
- glenohumeral osteoarthritis
- WORC score \> 70
- uncontrolled diabetes (Hgb A1C \>7%)
- pregnancy
- presence of local or systemic infection
- inability to cooperate with and/or comprehend post-operative instructions
- cancer
- paralysis of the shoulder
- contracture of the shoulder
- inability to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, 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 Halifax, Nova Scotia, 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.