Microfracture at Proximal Humerus Lateral to Footprint Could Enhance the Rotator Cuff Healing

November 17, 2022 updated by: Affiliated Hospital of Nantong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingbing Xiao, Ph.D
  • Phone Number: +86051381162222
  • Email: tdfykjc@163.com

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Not yet recruiting
        • Affiliated Hospital Of Nantong University
        • Contact:
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • Afiliated Hospital of Nantong University
        • Contact:
          • Mingbing Xiao, MD
          • Phone Number: +86051385052222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateralized microfracture group
Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair with microfracture at the lateral side of the footprint immediately.
Procedure: Lateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
No Intervention: No microfracture group
Participants with medium to larger size rotator cuff tears will be treated with arthroscopy rotator cuff repair without microfracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active range of motion of Shoulder
Time Frame: Preoperative, 3 months and 24 months postoperative
Active forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.
Preoperative, 3 months and 24 months postoperative
Passive range of motion of Shoulder
Time Frame: Preoperative, 3 months and 24 months postoperative
Passive forward flexion, abduction and external rotation will be measured with a manual goniometer at the preoperative visit, 3 months and 24 months after surgery.
Preoperative, 3 months and 24 months postoperative
American Shoulder and Elbow Score
Time Frame: Preoperative, 3 months and 24 months postoperative
American Shoulder and Elbow scores (minimum 0 points, maximum 100 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.
Preoperative, 3 months and 24 months postoperative
University at California at Los Angeles Shouder Rating Scale
Time Frame: Preoperative, 3 months and 24 months postoperative
University at California at Los Angeles Shoulder Rating Scale(minimum 3 points, maximum 35 points, higher values are considered better outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months and 24 months after surgery.
Preoperative, 3 months and 24 months postoperative
Visual Analog Scale for Pain
Time Frame: Preoperative, 3 months and 24 months postoperative
Visual Analog Scale for Pain(minimum 0 points, maximum 10 points, higher values are considered worse outcomes) of patients with rotator cuff tears treated with and without lateralized microfracture at the preoperative visit, 3 months, and 24 months after surgery.
Preoperative, 3 months and 24 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Principal Investigator: Yucheng Sun, Ph.D, Affiliated Hospital Of Nantong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • micorfracture

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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