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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lateral Epicondylitis; PRP
• Intervention / Treatment: Drug: PRP; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Arthroscopic treatment with PRP injection	Drug: PRP; After the arthroscopic operation was completed, a local PRP injection was performed
Placebo Comparator: Control group; Arthroscopic treatment with normal saline injection	Drug: normal saline; After the arthroscopic operation was completed, a local normal saline injection was performed

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Jishuitan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: YiL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No