A New Modified Suture Bridge Technique

NCT04825249 | Completed

• 1 other identifier: zhangyi
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Keywords

rotator cuff tear， modified suture bridge technique

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  at 12 months postoperatively

• Range of shoulder motion

  Different range of motion of shoulder joint

  at 12 months postoperatively

• The Visual Analog Scale score

  Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  preoperatively

• The Visual Analog Scale score

  Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).

  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.

  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.

  at 12 months postoperatively

Secondary Outcomes (4)

• Constant-Murray Shoulder score

  preoperatively

• Constant-Murray Shoulder score

  at 12 months postoperatively

• American Shoulder and Elbow Surgeon score

  preoperatively

• American Shoulder and Elbow Surgeon score

  at 12 months postoperatively

Study Arms (2)

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

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

Procedure: modified suture bridge technique

Interventions

traditional suture bridge technique PROCEDURE

(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

The traditional suture bridge technique group

modified suture bridge technique PROCEDURE

(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

The modified suture bridge technique group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Shangdong, China

Location

Related Publications (3)

• 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.

  PMID: 32663065 RESULT

• 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.

  PMID: 30153852 RESULT

• 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.

  PMID: 31147110 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Tengbo Yu

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: December 30, 2018
• Primary Completion: December 2, 2020
• Study Completion: January 5, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• 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

Locations

CN (1)