Rotator Cuff Tears Clinical Trial
Official title:
Comparison of Repair Integrity and Functional Outcomes Between Knot-tying and Knotless Suture-bridge Arthroscopic Rotator Cuff Repair: a Prospective Randomized Clinical Trial
Suture-bridge technique has been widely used for rotator cuff tears with many studies showing superior clinical results and lower failure rates compared to other techniques. This study aims to compare clinical outcomes and radiological integrity of arthroscopic rotator cuff repair between knot-tying and knotless suture-bridge techniques. The possibility of tendon strangulation and necrosis at the medial row when performing a suture-bridge technique may lead to retear and structural failure. In order to avoid this complication, the knots used at the medial row and their tension might be a factor to consider. Our hypothesis is that a knotless suture-bridge technique might avoid tendon strangulation thus might have lower retear rates.
This study has been planned as a prospective randomized clinical trial. We used a completely
computer-generated list in order to randomize all participants to receive one of two
treatments (https://www.random.org/sequences/).
Rotator cuff tear diagnosis will be made by physical examination and magnetic resonance
imaging. Participants who agree to be enrolled to study will be examined one day prior to
surgery. Half of the participants will undergo an arthroscopic rotator cuff repair with
knot-tying suture-bridge technique, while the other half will receive a knotless
suture-bridge technique. All the surgeries will be performed by the same senior surgeon
experienced in shoulder surgery under general anesthesia with participant in beach-chair
position.
All participants will receive a standard postoperative rehabilitation program starting
immediately after surgery with active elbow and passive shoulder exercises. The operated
upper extremity will be placed in a sling for 6 weeks. Active-assisted exercises will be
started at 6 weeks postoperatively.
Postoperative evaluations will be performed regularly at 2 weeks, 6 weeks, 3 months, 6
months, 12 months postoperatively and each following year. The results of last follow-up will
be analyzed. To assess repair integrity and tendon healing, a postoperative magnetic
resonance imaging scan will be performed to all participants at 6 months postoperatively. The
results of prospective clinical follow-up data and radiological evaluation will be analyzed
in order to compare clinical outcomes, failure rates and patterns of knot-tying and knotless
suture-bridge arthroscopic rotator cuff repair techniques.
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