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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982108
• Other study ID #: IU-260133
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: July 2, 2020

Study information

• Verified date: July 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Koray Sahin

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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 r — View Citation

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. Erratum — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Shoulder range of motion	Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer	Change from baseline range of motion at 12 months
Secondary	Visual analog scale for pain	A visual scale which classifies the intensity of pain between 0-10.	Change from baseline visual analog scale for pain at 12 months
Secondary	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.	6 months postoperatively

External Links

•   Web site used for randomization of participants