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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tears, Micro Fracture

Intervention / Treatment
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* Procedure: Lateralised microfracture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI) | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotator cuff tear, microfracture