A New Modified Suture Bridge Technique
Primary Purpose
Rotator Cuff Tears
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional suture bridge technique
modified suture bridge technique
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring rotator cuff tear, modified suture bridge technique
Eligibility Criteria
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
Sites / Locations
- The Affiliated Hospital of Qingdao University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
The traditional suture bridge technique group
The modified suture bridge technique group
Arm Description
For the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed
For the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed
Outcomes
Primary Outcome Measures
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.
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.
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.
Range of shoulder motion
Different range of motion of shoulder joint
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04825249
First Posted
March 29, 2021
Last Updated
March 29, 2021
Sponsor
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT04825249
Brief Title
A New Modified Suture Bridge Technique
Official Title
A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2018 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
January 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
rotator cuff tear, modified suture bridge technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The traditional suture bridge technique group
Arm Type
Experimental
Arm Description
For the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed
Arm Title
The modified suture bridge technique group
Arm Type
Experimental
Arm Description
For the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed
Intervention Type
Procedure
Intervention Name(s)
traditional suture bridge technique
Intervention Description
(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
Intervention Type
Procedure
Intervention Name(s)
modified suture bridge technique
Intervention Description
(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
Primary Outcome Measure Information:
Title
Cuff integrity grade of MRI assessment
Description
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.
Time Frame
at 12 months postoperatively
Title
Muscle atrophy grade of MRI assessment
Description
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.
Time Frame
at 12 months postoperatively
Title
Fatty degeneration grade of MRI assessment
Description
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.
Time Frame
at 12 months postoperatively
Title
Range of shoulder motion
Description
Different range of motion of shoulder joint
Time Frame
at 12 months postoperatively
Title
The Visual Analog Scale score
Description
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time Frame
preoperatively
Title
The Visual Analog Scale score
Description
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Time Frame
at 12 months postoperatively
Title
University of California-Los Angeles score
Description
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.
Time Frame
preoperatively
Title
University of California-Los Angeles score
Description
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.
Time Frame
at 12 months postoperatively
Secondary Outcome Measure Information:
Title
Constant-Murray Shoulder score
Description
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.
Time Frame
preoperatively
Title
Constant-Murray Shoulder score
Description
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.
Time Frame
at 12 months postoperatively
Title
American Shoulder and Elbow Surgeon score
Description
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.
Time Frame
preoperatively
Title
American Shoulder and Elbow Surgeon score
Description
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.
Time Frame
at 12 months postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(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.
Exclusion Criteria:
(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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tengbo Yu
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Shangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Proposals should be directed to zhangsports2021@sina.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website
IPD Sharing URL
http://www.medresman.org.cn/uc/sindex.aspx
Citations:
PubMed Identifier
32663065
Citation
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.
Results Reference
result
PubMed Identifier
30153852
Citation
Kim 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 Reference
result
PubMed Identifier
31147110
Citation
Dukan 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.
Results Reference
result
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A New Modified Suture Bridge Technique
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