Rotator Cuff TearsNCT03982108
Comparison of Two Arthroscopic Rotator Cuff Repair Techniques: Knot-tying Versus Knotless Suture-bridge Technique
A study testing Arthroscopic rotator cuff repair with knotless suture-bridge technique and Arthroscopic rotator cuff repair with knot-tying suture-bridge technique in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Koray Sahin at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Arthroscopic rotator cuff repair with knotless suture-bridge technique and Arthroscopic rotator cuff repair with knot-tying suture-bridge technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2017to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty Department of Orthopedics and Traumatology
Istanbul, Fatih, 34093
About this study
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
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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- Arthroscopic rotator cuff repair with knotless suture-bridge technique, Arthroscopic rotator cuff repair with knot-tying suture-bridge technique
- Keywords
- shoulder, rotator cuff tear, arthroscopic repair, suture-bridge technique, retear, knotless, knot-tying
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repair with knotless suture-bridge techniqueProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Knotless suture-bridge technique | Experimental | All participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique. Receives: 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. Receives: Procedure: Arthroscopic rotator cuff repair with knot-tying suture-bridge technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Change from baseline Constant shoulder score at 12 months
Secondary outcomes (3)
Shoulder range of motion
Shoulder abduction, forward flexion, external rotation, internal rotation and extension degrees measured by a goniometer
Measured: Change from baseline range of motion at 12 months
Visual analog scale for pain
A visual scale which classifies the intensity of pain between 0-10.
Measured: Change from baseline visual analog scale for pain at 12 months
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.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start3 May 2017
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koray Sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Koray Sahin, Istanbul University
- Investigators
- Ali Ersen, M.D., Principal investigator, Istanbul University Istanbul Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982108
- Sponsor's protocol ID
- IU-260133
- Status last verified
- Jul 2020
- First submitted
- 6 Jun 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22588743Sugaya 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.
PubMed 16325080Rhee 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.
PubMed 23002202Kim 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.
PubMed 24585674Millett 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.
PubMed 28748291Sahin 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.
PubMed 33954223
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03982108
- Acronym / sponsor ID
- IU-260133
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- shoulder, rotator cuff tear, arthroscopic repair, suture-bridge technique, retear, knotless, knot-tying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Koray SahinUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knotless suture-bridge technique | Experimental | Procedure: Arthroscopic rotator cuff repair with knotless suture-bridge techniqueAll participants in this arm will undergo an arthroscopic rotator cuff repair with knotless suture-bridge technique. |
| Knot-tying suture-bridge technique | Active comparator | Procedure: Arthroscopic rotator cuff repair with knot-tying suture-bridge techniqueAll participants in this arm will undergo an arthroscopic rotator cuff repair with knot-tying suture-bridge technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Full thickness rotator cuff tear repaired by arthroscopic suture-bridge technique
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repair with knotless suture-bridge techniqueA 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. | Procedure or surgery | Knotless suture-bridge technique |
| Arthroscopic rotator cuff repair with knot-tying suture-bridge techniqueAfter 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. | Procedure or surgery | Knot-tying suture-bridge technique |
Primary outcome
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
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.
3 secondary outcomes
Shoulder range of motion
Time frame: Change from baseline range of motion at 12 months
Visual analog scale for pain
Time frame: Change from baseline visual analog scale for pain at 12 months
Retear patterns of rotator cuff tendons
Time frame: 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 22588743Angst 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.
- Background: PubMed 16325080Sugaya 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 publication: PubMed 23002202Rhee 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.
- Results publication: PubMed 24585674Kim 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 publication: PubMed 28748291Millett 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.
- Derived from this study: PubMed 33954223Sahin 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.
- Web site used for randomization of participantsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ersen, M.D. principal investigator
Istanbul University Istanbul Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair with knotless suture-bridge technique and Arthroscopic rotator cuff repair with knot-tying suture-bridge technique in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Koray Sahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sugaya classification of rotator cuff integrity (time frame: 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982108, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.