Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique

Koray Sahin

Status: Completed

Conditions: Rotator Cuff Injuries; Rotator Cuff Tears

Treatments: Procedure: Arthroscopic rotator cuff repair with knot-tying suture-bridge technique; Procedure: Arthroscopic rotator cuff repair with knotless suture-bridge technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03982108

IU-260133

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique

Exclusion criteria

• Partial thickness rotator cuff tear
• Presence of a full thickness subscapularis tear that requires a repair
• History of a neurological disease
• Presence of severe glenohumeral or acromioclavicular arthritis
• Presence of a metal implant which prevents magnetic resonance imaging scan
• Tears repaired with other techniques
• Revision surgeries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Knotless suture-bridge technique

Experimental group

Description:

All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique.

Treatment:

Procedure: Arthroscopic rotator cuff repair with knotless suture-bridge technique

Knot-tying suture-bridge technique

Active Comparator group

Description:

All participants in this arm will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique.

Treatment:

Procedure: Arthroscopic rotator cuff repair with knot-tying suture-bridge technique