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

NCT03982108 | Completed

• 1 other identifier: IU-260133
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries

Keywords

shoulder; rotator cuff tear; arthroscopic repair; suture-bridge technique; retear; knotless; knot-tying

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Change from baseline Constant shoulder score at 12 months

Secondary Outcomes (3)

• Shoulder range of motion

  Change from baseline range of motion at 12 months

• Visual analog scale for pain

  Change from baseline visual analog scale for pain at 12 months

• Retear patterns of rotator cuff tendons

  6 months postoperatively

Study Arms (2)

Knotless suture-bridge technique

EXPERIMENTAL

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

Knot-tying suture-bridge technique

ACTIVE COMPARATOR

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

Interventions

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.

Knotless suture-bridge technique

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.

Knot-tying suture-bridge technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koray Sahin: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (6)

• Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.

  PMID: 22588743 BACKGROUND

• Sugaya H, Maeda K, Matsuki K, Moriishi J. Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation. Arthroscopy. 2005 Nov;21(11):1307-16. doi: 10.1016/j.arthro.2005.08.011.

  PMID: 16325080 BACKGROUND

• Rhee YG, Cho NS, Parke CS. Arthroscopic rotator cuff repair using modified Mason-Allen medial row stitch: knotless versus knot-tying suture bridge technique. Am J Sports Med. 2012 Nov;40(11):2440-7. doi: 10.1177/0363546512459170. Epub 2012 Sep 21.

  PMID: 23002202 RESULT

• Kim KC, Shin HD, Cha SM, Park JY. Comparisons of retear patterns for 3 arthroscopic rotator cuff repair methods. Am J Sports Med. 2014 Mar;42(3):558-65. doi: 10.1177/0363546514521577.

  PMID: 24585674 RESULT

• Millett PJ, Espinoza C, Horan MP, Ho CP, Warth RJ, Dornan GJ, Katthagen JC. Predictors of outcomes after arthroscopic transosseous equivalent rotator cuff repair in 155 cases: a propensity score weighted analysis of knotted and knotless self-reinforcing repair techniques at a minimum of 2 years. Arch Orthop Trauma Surg. 2017 Oct;137(10):1399-1408. doi: 10.1007/s00402-017-2750-7. Epub 2017 Jul 26.

  PMID: 28748291 RESULT

• Sahin K, Senturk F, Ersin M, Arzu U, Chodza M, Ersen A. Repair Integrity and Functional Outcomes Between Knot-Tying and Knotless Suture-Bridge Arthroscopic Rotator Cuff Repair: A Prospective Randomized Clinical Trial. Orthop J Sports Med. 2021 Apr 19;9(4):23259671211002482. doi: 10.1177/23259671211002482. eCollection 2021 Apr.

  PMID: 33954223 DERIVED

Related Links

• Web site used for randomization of participants

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Ali Ersen, M.D.

  Istanbul University Istanbul Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident in orthopedics and traumatology department

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: May 3, 2017
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)