Combined Microfracture Procedure Promotes Tendon Healing

Study Overview
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Brief Summary
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This study is a prospective randomized controlled study of Combined microfracture procedure promotes tendon healing during double raw repair for full tear rotator cuff. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and 6 weeks, 3 months, 6 months, 12 months and 24months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw repair combined with microfracture on the treatment of rotator cuff.

Official Title
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Combined Microfracture Procedure Promotes Tendon Healing During Double Raw Repair for Full Tear Rotator Cuff - a Prospective Randomized Study With 2-year Follow-up

Conditions
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Full Rotator Cuff Tear, Microfracture Procedure, Double Raw Repair

Intervention / Treatment
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* Procedure: microfracture procedure
* Procedure: only double raw repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arthroscopy confirmed small to medium full rotator cuff tear Unilateral rotator cuff injury Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients Young and middle-aged patients aged 20 to 60 Exclusion Criteria: Previous shoulder surgery (incision or arthroscopy) Combined with diseases of other parts of the same limb Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on Bilateral onset Unable or unwilling to receive clinical follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>double raw repair for full tear rotator cuff combined microfracture procedure | Procedure: microfracture procedure<br>* double raw repair combined with microfracture procedure which promotes tendon healing by releasing growth factors<br>|
| Placebo Comparator: Control group<br>double raw repair for full tear rotator cuff | Procedure: only double raw repair<br>* the double raw repair was used to repair the tendon tear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rotator cuff re-tear rate | the rotator cuff re-tear rate was measured by MRI, MRI was performed to identify the status of the tendon | 2 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analogue Scale) | A score used to evaluate the pain | 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively | 
| ASES（American Shoulder and Elbow Surgeons'Form） | A score used to evaluate the shoulder function | 3,6,12,24 months postoperatively | 
| Constant score | A score used to evaluate the shoulder function | 3,6,12,24 months postoperatively | 
| UCLA (University LosAngeles scoring system) | A score used to evaluate the shoulder function | 3,6,12,24 months postoperatively | 
| SST (simple shoulder test) | A score used to evaluate the shoulder function | 3,6,12,24 months postoperatively | 
| front extension, external rotation and internal rotation strength of shoulder | Use a dynamometer to measure in N | 6,12,24 months postoperatively |