Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair

Affiliated Hospital of Nantong University2 sites in 1 country88 target enrollmentOctober 1, 2022

ConditionsRotator Cuff Tears Micro Fracture

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rotator Cuff Tears
Sponsor: Affiliated Hospital of Nantong University
Enrollment: 88
Locations: 2
Primary Endpoint: Magnetic Resonance Imaging (MRI)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to test whether there is any effect on rotator cuff healing by making microfracture at the lateral side of the footprint. The main question it aims to answer are:

[whether the lateralized microfracture could decrease the retear rate after arthroscopy rotator cuff repair.]
[whether the lateralized microfracture could improve the functional recovery after arthroscopy rotator cuff repair.] Participants with medium to larger size rotator cuff tears will be randomly assigned to the study group treated with lateralized microfracture immediately after arthroscopy rotator cuff repair or the control group treated with conventional arthroscopy rotator cuff repair without microfracture.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

December 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Affiliated Hospital of Nantong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Medium to large Rotator cuff tear(1cm-5cm) diagnosed by MRI
•Patients can complete the follow-up and comply with all post-operative rehab instructions
•Failure of non-operative treatment for at least 3 months

Exclusion Criteria

•Revision rotator cuff surgery
•Partial thickness rotator cuff tears
•Small (less than 1cm) and Massive (greater than 5cm) rotator cuff tears
•Disease history of the affected shoulder
•Systemic immune diseases
•Irreparable rotator cuff tear

Outcomes

Primary Outcomes

Magnetic Resonance Imaging (MRI)

Time Frame: 24 months postoperative

The scans were evaluated for rotator cuff integrity and degree of re-tears (no re-tears, partial or complete re-tear) by an independent radiologist

Secondary Outcomes

American Shoulder and Elbow Score(Preoperative, 3 months and 24 months postoperative)
University at California at Los Angeles Shouder Rating Scale(Preoperative, 3 months and 24 months postoperative)
Visual Analog Scale for Pain(Preoperative, 3 months and 24 months postoperative)
Passive range of motion of Shoulder(Preoperative, 3 months and 24 months postoperative)
Active range of motion of Shoulder(Preoperative, 3 months and 24 months postoperative)