Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

Study Overview
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Brief Summary
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This study is a prospective randomized controlled study of different arthroscopic treatments for refractory external humeral epicondylitis combined with platelet rich plasma (PRP) injection. The patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local PRP injection group and a control group (normal saline) to perform additional operations on the damaged tendons, each for up to half a year after the operation. 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 arthroscopic treatment combined with PRP on the treatment of damaged tendons. Determine the effectiveness of PRP. At the same time, in the process of arthroscopic treatment, look for risk factors that affect the curative effect of intractable external humeral epicondylitis, as well as the causes and prevention of common complications.

Official Title
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Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

Conditions
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PRP, Lateral Epicondylitis

Intervention / Treatment
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* Drug: PRP
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed patients with refractory external humeral epicondylitis (preoperative MRI confirmed loss of ECRB integrity) patients who have received non-surgical treatment with poor efficacy Young and middle-aged patients aged 20 to 60, who have not previously received local injection therapy Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients Unilateral disease Exclusion Criteria: Early patients who have not received standard non-surgical treatment Patients who have received hormone injections or small needle knife therapy and other invasive procedures within three months before surgery, poor skin conditions, and local infections Elderly people older than 60 years old and patients younger than 20 years old Unable to accept randomization, insufficient follow-up time or lost to follow-up Bilateral disease Combined immune disease

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>Arthroscopic treatment with PRP injection | Drug: PRP<br>* After the arthroscopic operation was completed, a local PRP injection was performed<br>|
| Placebo Comparator: Control group<br>Arthroscopic treatment with normal saline injection | Drug: normal saline<br>* After the arthroscopic operation was completed, a local normal saline injection was performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo Elbow Performance Score | A score used to evaluated the elbow function | 1 year postoperatively | 
| Integrity of the tendon in MRI | MRI was performed to identify the status of the tendon | 1 year postoperatively |