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Clinical Trials/NCT04686968
NCT04686968
Unknown
Not Applicable

Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in the Treatment of Medium-sized Full-thickness Rotator Cuff Injuries: A Prospective Randomized Controlled Study

Beijing Jishuitan Hospital0 sites48 target enrollmentJuly 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tears
Sponsor
Beijing Jishuitan Hospital
Enrollment
48
Primary Endpoint
tendon integrity
Last Updated
5 years ago

Overview

Brief Summary

Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Detailed Description

Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Registry
clinicaltrials.gov
Start Date
July 2021
End Date
July 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chunyan Jiang

Director of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

Eligibility Criteria

Inclusion Criteria

  • Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
  • Between 20-65 years old

Exclusion Criteria

  • Bilateral rotator cuff tear
  • Underwent ipsilateral surgery
  • Large-to-massive rotator cuff tear
  • Combined with Bankart, SLAP or AC lesion
  • Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration

Outcomes

Primary Outcomes

tendon integrity

Time Frame: 1 year postoperatively

MRI was used to assess the integrity of the repaired rotator cuff tendon

Visual Analogue Scale(VAS)

Time Frame: 2 year postoperatively

A patient-reported outcome uesed to assess pain severityrange 0-10, higher scores mean a worse outcome

American Shoulder and Elbow Surgeons Shoulder (ASES) score

Time Frame: 2 years postoperatively

A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome

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