Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

Not Applicable

• Conditions: Rotator Cuff Tears; Microfractures

• Registration Number: NCT04686968
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29
• Study Start: 2021-07
• Primary Completion: 2023-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
tendon integrity	1 year postoperatively	MRI was used to assess the integrity of the repaired rotator cuff tendon
Visual Analogue Scale(VAS)	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	2 years postoperatively	A patient-reported outcome uesed to assess the shoulder function,range 0-100, higher scores mean a better outcome