Rotator Cuff TearsNCT04825249
A New Modified Suture Bridge Technique
A study testing traditional suture bridge technique and modified suture bridge technique in people with Rotator Cuff Tears, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- traditional suture bridge technique and modified suture bridge technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2018to 5 Jan 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.
Who cannot join
- (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon，biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study
We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
Read the detailed description
Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.
- Conditions
- Rotator Cuff Tears
- Being tested
- traditional suture bridge technique, modified suture bridge technique
- Keywords
- rotator cuff tear， modified suture bridge technique
- 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.
traditional suture bridge techniqueProcedure or surgery
(A) Limbs of the sutures from the medial anchor were passed through torn tendon (B) the suture limbs were tied in a horizontal mattress suture pattern (C) the lateral row pressed the free tails of the knotted line on the greater tubercle of the humerus (D) the effect after completion of the TSB technique
modified suture bridge techniqueProcedure or surgery
(A) Limbs of the sutures from the medial anchor and 2 tendon sutures were passed through the same position of torn tendon (B) the lateral row pressed free tails of the two tendon lines on the greater tubercle of the humerus (C) after examination of sufficient tension and stable fixation, sutures of medial row was knotted (D) the effect after completion of the MSB technique
| Study group | Role | What they receive |
|---|---|---|
| The traditional suture bridge technique group | Experimental | For the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed Receives: Procedure: traditional suture bridge technique |
| The modified suture bridge technique group | Experimental | For the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed Receives: Procedure: modified suture bridge technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff integrity grade of MRI assessment
Grade I: sufficient thickness of tendon; Grade II: sufficient thickness of tendon and partial high intensity within tendon; Grade III: insufficient thickness of tendon without discontinuity; Grade IV: slight discontinuity in 1 or 2 images of oblique coronal plane and sagittal plane; Grade V:obvious discontinuity of tendons in more than 2 images of both oblique coronal plane and sagittal plane.
Measured: at 12 months postoperatively
Muscle atrophy grade of MRI assessment
Grade I: a ratio between 1.00 and 0.60 can be considered as normal or slightly atrophied; Grade II: values between 0.60 and 0.40 suggest moderate atrophy. Grade III: values below 0.40 indicate serious or severe atrophy.
Measured: at 12 months postoperatively
Fatty degeneration grade of MRI assessment
Grade 0: completely normal muscle; Grade 1: muscle contains some fatty streaks; Grade 2: there is more muscle than fat; Grade 3: equal distribution of fat and muscle; grade 4: more fat was present than muscle. Among them, grade 0 is normal, grade 1 and 2 are considered moderate, grade 3 and 4 are classified as severe.
Measured: at 12 months postoperatively
Range of shoulder motion
Different range of motion of shoulder joint
Measured: at 12 months postoperatively
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: preoperatively
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Measured: at 12 months postoperatively
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: preoperatively
University of California-Los Angeles score
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
Measured: at 12 months postoperatively
Secondary outcomes (4)
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100#a higher score means a better result.
Measured: preoperatively
Constant-Murray Shoulder score
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100#a higher score means a better result.
Measured: at 12 months postoperatively
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: preoperatively
American Shoulder and Elbow Surgeon score
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
Measured: at 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start30 Dec 2018
- Primary completion2 Dec 2020
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tengbo Yu, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825249
- Sponsor's protocol ID
- zhangyi
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Publications
Takeuchi Y, Sugaya H, Takahashi N, Matsuki K, Tokai M, Morioka T, Ueda Y, Hoshika S. Repair Integrity and Retear Pattern After Arthroscopic Medial Knot-Tying After Suture-Bridge Lateral Row Rotator Cuff Repair. Am J Sports Med. 2020 Aug;48(10):2510-2517. doi: 10.1177/0363546520934786. Epub 2020 Jul 14.
PubMed 32663065Kim KC, Shin HD, Lee WY, Yeon KW, Han SC. Clinical outcomes and repair integrity of arthroscopic rotator cuff repair using suture-bridge technique with or without medial tying: prospective comparative study. J Orthop Surg Res. 2018 Aug 28;13(1):212. doi: 10.1186/s13018-018-0921-z.
PubMed 30153852Dukan R, Ledinot P, Donadio J, Boyer P. Arthroscopic Rotator Cuff Repair With a Knotless Suture Bridge Technique: Functional and Radiological Outcomes After a Minimum Follow-Up of 5 Years. Arthroscopy. 2019 Jul;35(7):2003-2011. doi: 10.1016/j.arthro.2019.02.028. Epub 2019 May 27.
PubMed 31147110
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study
- ClinicalTrials.gov ID
- NCT04825249
- Acronym / sponsor ID
- zhangyi
- Conditions
- Rotator Cuff Tears
- Keywords
- rotator cuff tear， modified suture bridge technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 1 Apr 2021 (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.
We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
Detailed description
Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.
Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The traditional suture bridge technique group | Experimental | Procedure: traditional suture bridge techniqueFor the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed |
| The modified suture bridge technique group | Experimental | Procedure: modified suture bridge techniqueFor the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.
Key exclusion criteria (1 listed)
- (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon，biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.
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 |
|---|---|---|
| traditional suture bridge technique(A) Limbs of the sutures from the medial anchor were passed through torn tendon (B) the suture limbs were tied in a horizontal mattress suture pattern (C) the lateral row pressed the free tails of the knotted line on the greater tubercle of the humerus (D) the effect after completion of the TSB technique | Procedure or surgery | The traditional suture bridge technique group |
| modified suture bridge technique(A) Limbs of the sutures from the medial anchor and 2 tendon sutures were passed through the same position of torn tendon (B) the lateral row pressed free tails of the two tendon lines on the greater tubercle of the humerus (C) after examination of sufficient tension and stable fixation, sutures of medial row was knotted (D) the effect after completion of the MSB technique | Procedure or surgery | The modified suture bridge technique group |
Primary outcome
Cuff integrity grade of MRI assessment
Time frame: at 12 months postoperatively
Grade I: sufficient thickness of tendon; Grade II: sufficient thickness of tendon and partial high intensity within tendon; Grade III: insufficient thickness of tendon without discontinuity; Grade IV: slight discontinuity in 1 or 2 images of oblique coronal plane and sagittal plane; Grade V:obvious discontinuity of tendons in more than 2 images of both oblique coronal plane and sagittal plane.
Muscle atrophy grade of MRI assessment
Time frame: at 12 months postoperatively
Grade I: a ratio between 1.00 and 0.60 can be considered as normal or slightly atrophied; Grade II: values between 0.60 and 0.40 suggest moderate atrophy. Grade III: values below 0.40 indicate serious or severe atrophy.
Fatty degeneration grade of MRI assessment
Time frame: at 12 months postoperatively
Grade 0: completely normal muscle; Grade 1: muscle contains some fatty streaks; Grade 2: there is more muscle than fat; Grade 3: equal distribution of fat and muscle; grade 4: more fat was present than muscle. Among them, grade 0 is normal, grade 1 and 2 are considered moderate, grade 3 and 4 are classified as severe.
Range of shoulder motion
Time frame: at 12 months postoperatively
Different range of motion of shoulder joint
The Visual Analog Scale score
Time frame: preoperatively
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
Time frame: at 12 months postoperatively
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
University of California-Los Angeles score
Time frame: preoperatively
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
Time frame: at 12 months postoperatively
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
4 secondary outcomes
Constant-Murray Shoulder score
Time frame: preoperatively
Constant-Murray Shoulder score
Time frame: at 12 months postoperatively
American Shoulder and Elbow Surgeon score
Time frame: preoperatively
American Shoulder and Elbow Surgeon score
Time frame: at 12 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 1 Apr 2021.
- Results publication: PubMed 32663065Takeuchi Y, Sugaya H, Takahashi N, Matsuki K, Tokai M, Morioka T, Ueda Y, Hoshika S. Repair Integrity and Retear Pattern After Arthroscopic Medial Knot-Tying After Suture-Bridge Lateral Row Rotator Cuff Repair. Am J Sports Med. 2020 Aug;48(10):2510-2517. doi: 10.1177/0363546520934786. Epub 2020 Jul 14.
- Results publication: PubMed 30153852Kim KC, Shin HD, Lee WY, Yeon KW, Han SC. Clinical outcomes and repair integrity of arthroscopic rotator cuff repair using suture-bridge technique with or without medial tying: prospective comparative study. J Orthop Surg Res. 2018 Aug 28;13(1):212. doi: 10.1186/s13018-018-0921-z.
- Results publication: PubMed 31147110Dukan R, Ledinot P, Donadio J, Boyer P. Arthroscopic Rotator Cuff Repair With a Knotless Suture Bridge Technique: Functional and Radiological Outcomes After a Minimum Follow-Up of 5 Years. Arthroscopy. 2019 Jul;35(7):2003-2011. doi: 10.1016/j.arthro.2019.02.028. Epub 2019 May 27.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Tengbo Yu study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional suture bridge technique and modified suture bridge technique in people with Rotator Cuff Tears, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 1 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 1 Apr 2021. 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 China. 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?
Cuff integrity grade of MRI assessment (time frame: at 12 months postoperatively). The study lists 8 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 NCT04825249, which also lists 3 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 1 Apr 2021.