Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
Comparison of Repair Integrity and Functional Outcomes Between Knot-tying and Knotless Suture-bridge Arthroscopic Rotator Cuff Repair: a Prospective Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fatih
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Istanbul, Fatih, Turkey, 34093
- Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Knotless suture-bridge technique
All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique.
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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. |
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Active Comparator: Knot-tying suture-bridge technique
All participants in this arm will undergo an 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sugaya classification of rotator cuff integrity
Time Frame: 6 months postoperatively
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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
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6 months postoperatively
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Constant shoulder score
Time Frame: Change from baseline Constant shoulder score at 12 months
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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.
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Change from baseline Constant shoulder score at 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Change from baseline range of motion at 12 months
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Visual analog scale for pain
Time Frame: Change from baseline visual analog scale for pain at 12 months
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A visual scale which classifies the intensity of pain between 0-10.
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Change from baseline visual analog scale for pain at 12 months
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Retear patterns of rotator cuff tendons
Time Frame: 6 months postoperatively
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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.
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6 months postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Ersen, M.D., Istanbul University Istanbul Medical Faculty
Publications and helpful links
General Publications
- 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.
- 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.
- 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 In: Am J Sports Med. 2013 Aug;41(8):NP41.
- 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.
- 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. Erratum In: Arch Orthop Trauma Surg. 2017 Dec;137(12 ):1761.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IU-260133
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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