Micro Fracture, Rotator Cuff Tears
Conditions
Keywords
rotator cuff tear, microfracture
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.
Interventions
PROCEDURELateralised microfracture
making microfracture(4 holes with 2mm diameter) at the lateral side of the footprint right after arthroscopy rotator repair.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactMingbing Xiao, Ph.D
Outcome results
None listed