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

• Sponsor: Affiliated Hospital of Nantong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05624164
• Collaborator: (none)
• Enrollment: 88
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 44
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears; Micro Fracture	Procedure: Lateralised microfracture	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Patients Treated With and Without Lateralized Microfracture During Rotator Cuff Repair
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Magnetic Resonance Imaging (MRI) [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 Outcome Measures

1. Active range of motion of Shoulder [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.

2. Passive range of motion of Shoulder [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.

3. American Shoulder and Elbow Score [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.

4. University at California at Los Angeles Shouder Rating Scale [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.

5. Visual Analog Scale for Pain [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital of Nantong University	Nantong	Jiangsu	China	226001
2	Afiliated Hospital of Nantong University	Nantong	Jiangsu	China	226001

Sponsors and Collaborators

• Affiliated Hospital of Nantong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Affiliated Hospital of Nantong University
• ClinicalTrials.gov Identifier: NCT05624164
• Other Study ID Numbers: micorfracture
• First Posted: Nov 22, 2022
• Last Update Posted: Nov 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Affiliated Hospital of Nantong University: rotator cuff tear; microfracture
• Additional relevant MeSH terms: Rotator Cuff Injuries; Fractures, Stress

Study Results

No Results Posted as of Nov 22, 2022