An interventional study of Arthroscopic rotator cuff repair with knotless suture-bridge technique and Arthroscopic rotator cuff repair with knot-tying suture-bridge technique in Rotator Cuff Tears and Rotator Cuff Injuries, sponsored by Koray Sahin. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by Koray Sahin · Not applicable, Interventional, and Treatment
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 104 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
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Exclusion Criteria:
All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique.
Procedure: Arthroscopic rotator cuff repair with knotless suture-bridge technique
All participants in this arm will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique.
Procedure: Arthroscopic rotator cuff repair with knot-tying suture-bridge technique
A posterior portal will be established to obtain adequate visualization and an anterior portal will be established through rotator interval as a working portal for diagnostic arthroscopy and debridement. Then additional portals will be established and preperation of tendon will be performed and a burr will be used for footprint preperation. After determination of proper anchor locations, required number of suture anchors will be inserted just lateral to articular margin depending on the tear size. Then limbs of sutures will be passed from the rotator cuff and will be used to create a suture bridge over the tendon. Then these limbs will be loaded to anchors which will form the lateral row without tying the suture limbs at the medial row. These lateral anchors will be inserted to adequate location, just lateral and distal to greater tuberosity with adequate suture-bridge tension over the rotator cuff.
After the same preparation procedure as in knotless suture-bridge technique, required number of suture anchors will be inserted just lateral to articular margin depending on the tear size. Then limbs of sutures will be passed from the tendon and tied in a horizontal mattress suture pattern. After the establishment of medial row, suture limbs will be used to form a suture bridge over the tendon and will be loaded to lateral row anchors which then will be inserted lateral to greater tuberosity in a similar way to knotless repair technique.
Sugaya classification of rotator cuff integrity
This is a classification system described by Sugaya et al. which uses magnetic resonance imaging in order to evaluate tendon integrity after rotator cuff repair. Postoperative cuff integrity is classified into 5 categories: type I, sufficient thickness with homogenously low intensity; type II, sufficient thickness with partial high intensity; type III, insufficient thickness without discontinuity; type IV, presence of minor discontinuity; type V, presence of major discontinuity
Time frame: 6 months postoperatively
Constant shoulder score
This is a clinical functional assessment test used for shoulder disorders. The score consists of 4 sections: pain, activities of daily living, mobility and strength.
Time frame: Change from baseline Constant shoulder score at 12 months
Shoulder range of motion
Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer
Time frame: Change from baseline range of motion at 12 months
Visual analog scale for pain
A visual scale which classifies the intensity of pain between 0-10.
Time frame: Change from baseline visual analog scale for pain at 12 months
Retear patterns of rotator cuff tendons
Retear patterns of rotator cuff tendons will be evaluated by using postoperative magnetic resonance images. Detected retears will be classified as type 1 (lateral) or type 2 (medial/musculotendinous) rotator cuff retears/failures.
Time frame: 6 months postoperatively
Plan to share: No
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