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

Not Applicable

Recruiting

• Conditions: Micro Fracture; Rotator Cuff Tears
• Interventions: Procedure: Lateralised microfracture

• Registration Number: NCT05624164
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lateralized microfracture group	Lateralised microfracture	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (2)

Afiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China