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NCT Number: NCT03982108

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

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.

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic rotator cuff repair with knotless suture-bridge technique

Procedure

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.

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

Procedure

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.

Primary outcomes

  1. Sugaya classification of rotator cuff integrity

    Time frame: 6 months postoperatively

    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

  2. Constant shoulder score

    Time frame: Change from baseline Constant shoulder score at 12 months

    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.

Secondary outcomes

  1. Shoulder range of motion

    Time frame: Change from baseline range of motion at 12 months

    Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer

  2. Visual analog scale for pain

    Time frame: Change from baseline visual analog scale for pain at 12 months

    A visual scale which classifies the intensity of pain between 0-10.

  3. Retear patterns of rotator cuff tendons

    Time frame: 6 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Koray Sahin

Other

Registry information

Official study title

Comparison of Repair Integrity and Functional Outcomes Between Knot-tying and Knotless Suture-bridge Arthroscopic Rotator Cuff Repair: a Prospective Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2019
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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