Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
Overview
- Phase
- Not Applicable
- Intervention
- PRP
- Conditions
- PRP
- Sponsor
- Beijing Jishuitan Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mayo Elbow Performance Score
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Yi Lu
Director of Sports Medicine Service of Beijing Jishuitan hospital
Beijing Jishuitan Hospital
Eligibility Criteria
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
Arms & Interventions
Study group
Arthroscopic treatment with PRP injection
Intervention: PRP
Control group
Arthroscopic treatment with normal saline injection
Intervention: normal saline
Outcomes
Primary Outcomes
Mayo Elbow Performance Score
Time Frame: 3, 6 weeks and 3, 6, 12, 24 months postoperatively
A score used to evaluated the elbow function, higher scores mean a better outcome.
Secondary Outcomes
- visual analog scale (VAS)(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- scoring system of Verhaar(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Disability of the Arm, Shoulder, and Hand (DASH)(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Patient-Rated Tennis Elbow Evaluation (PRTEE) scale(3, 6 weeks and 3, 6, 12, 24months postoperatively)
- Integrity of the tendon in MRI(3, 6, 12, 24 months postoperatively)