A New Modified Suture Bridge Technique

NCT ID: NCT04825249

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-30

Study Completion Date

2021-01-05

Brief Summary

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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

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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

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.

Study Groups

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The traditional suture bridge technique group

For the TSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed

Group Type EXPERIMENTAL

traditional suture bridge technique

Intervention Type 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 modified suture bridge technique group

For the MSB group, if the tear type is confirmed to be medium-sized during the operation, TSB technique will be performed

Group Type EXPERIMENTAL

modified suture bridge technique

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tengbo Yu

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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The Affiliated Hospital of Qingdao University

Shangdong, , China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 32663065 (View on PubMed)

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.

Reference Type RESULT
PMID: 30153852 (View on PubMed)

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.

Reference Type RESULT
PMID: 31147110 (View on PubMed)

Other Identifiers

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zhangyi

Identifier Type: -

Identifier Source: org_study_id

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