Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
Primary Purpose
Rotator Cuff Tears, Rotator Cuff Injuries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair with knotless suture-bridge technique
Arthroscopic rotator cuff repair with knot-tying suture-bridge technique
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring shoulder, rotator cuff tear, arthroscopic repair, suture-bridge technique, retear, knotless, knot-tying
Eligibility Criteria
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
Sites / Locations
- Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Knotless suture-bridge technique
Knot-tying suture-bridge technique
Arm Description
All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique.
All participants in this arm will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Shoulder range of motion
Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer
Visual analog scale for pain
A visual scale which classifies the intensity of pain between 0-10.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03982108
Brief Title
Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Koray Sahin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Rotator Cuff Injuries
Keywords
shoulder, rotator cuff tear, arthroscopic repair, suture-bridge technique, retear, knotless, knot-tying
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Knotless suture-bridge technique
Arm Type
Experimental
Arm Description
All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique.
Arm Title
Knot-tying suture-bridge technique
Arm Type
Active Comparator
Arm Description
All participants in this arm will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair with knotless suture-bridge technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic rotator cuff repair with knot-tying suture-bridge technique
Intervention Description
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 Outcome Measure Information:
Title
Sugaya classification of rotator cuff integrity
Description
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
Time Frame
6 months postoperatively
Title
Constant shoulder score
Description
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.
Time Frame
Change from baseline Constant shoulder score at 12 months
Secondary Outcome Measure Information:
Title
Shoulder range of motion
Description
Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer
Time Frame
Change from baseline range of motion at 12 months
Title
Visual analog scale for pain
Description
A visual scale which classifies the intensity of pain between 0-10.
Time Frame
Change from baseline visual analog scale for pain at 12 months
Title
Retear patterns of rotator cuff tendons
Description
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.
Time Frame
6 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ersen, M.D.
Organizational Affiliation
Istanbul University Istanbul Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22588743
Citation
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.
Results Reference
background
PubMed Identifier
16325080
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. doi: 10.1016/j.arthro.2005.08.011.
Results Reference
background
PubMed Identifier
23002202
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 In: Am J Sports Med. 2013 Aug;41(8):NP41.
Results Reference
result
PubMed Identifier
24585674
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.
Results Reference
result
PubMed Identifier
28748291
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 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.
Results Reference
result
PubMed Identifier
33954223
Citation
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.
Results Reference
derived
Links:
URL
https://www.random.org/sequences/
Description
Web site used for randomization of participants
Learn more about this trial
Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
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