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Clinical Trials/NCT04825249
NCT04825249
Completed
Not Applicable

A New Modified Suture Bridge Technique for Medium-sized Rotator Cuff Tears: Functional and Radiological Outcomes of a Prospective Study

The Affiliated Hospital of Qingdao University1 site in 1 country50 target enrollmentDecember 30, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tears
Sponsor
The Affiliated Hospital of Qingdao University
Enrollment
50
Locations
1
Primary Endpoint
University of California-Los Angeles score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 30, 2018
End Date
January 5, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

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.

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).

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

Secondary Outcomes

  • American Shoulder and Elbow Surgeon score(at 12 months postoperatively)
  • Constant-Murray Shoulder score(at 12 months postoperatively)

Study Sites (1)

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