The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Patients in the reconstruction group will undergo maximal repair with interposition bridging using BioBrace. This technique will follow a previously described technique by the principal investigator with differences allocated to the graft, it's preparation and insertion. The bursa will be debrided, and rotator cuff edged will be shaved down to stable tissue. BioBrace is bioinductive scaffold composed of highly porous type I collagen and bio-resorbable poly (L-lactide) (PLLA) microfilaments, and will be used as the graft in this trial.
Patients in the maximal repair group will undergo a SCOI-row rotator cuff repair with adequate tension as described previously, with recreation of the rotator cable. Briefly, the SCOI-row rotator cuff repair uses one triple loaded suture anchor for each 1.2cm of torn tendon. This technique has been completed in a previous randomized controlled trial.
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
RECRUITINGRadiographic or clinical failure
The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up
Time frame: 2 years
Acromiohumeral Distance
Acromiohumeral distance (AHD) will be measured on pre- and post-operative x-rays.
Time frame: 2 year
Muscle Atrophy
Using MRI, muscle atrophy will be measured using Warner's classification between groups.
Time frame: 2 year
Fatty Infiltration
Fatty infiltration using the Goutallier classification will be used and identified
Time frame: 2 year
Healing Rate
To measure the structural integrity of the surgery, Sugaya method will be used.
Time frame: 2 year
Western Ontario Rotator Cuff Index (WORC)
WORC will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Time frame: Baseline, 6-month, 1-year, 2-years
American Shoulder and Elbow Surgeon survey
American Shoulder and Elbow Surgeon survey will be measured pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Time frame: Baseline, 6-month, 1-year, 2-years
EQ-5D-5L
EQ-5D-5L for overall health will be measured pre-operatively, and post-operatively at 6-months, 1-year, and 2-years
Time frame: Baseline, 6-month, 1-year, 2-years
Range of motion
The range of motion, measured in degrees for flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Time frame: Baseline, 6-month, 1-year, 2-years
Shoulder strength
The strength of patients flexion, extension, abduction, internal, and external rotation will be measured. These are measured and compared pre-operatively, and post-operatively and 6-months, 1-year, and 2-years
Time frame: Baseline, 6-month, 1-year, 2-years
Biomechanics and Muscle Activity
Pre- and post-operative (1-year) in-vivo biomechanics and electromyography will be compared between groups during a standardized shoulder lifting study in a laboratory based environment.
Time frame: Baseline and 2 years
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