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

• Sponsor: Beijing Jishuitan Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04556825
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 32.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PRP; Lateral Epicondylitis	Drug: PRP; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
• Anticipated Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mayo Elbow Performance Score [1 year postoperatively]

   A score used to evaluated the elbow function

2. Integrity of the tendon in MRI [1 year postoperatively]

   MRI was performed to identify the status of the tendon

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Beijing Jishuitan Hospital

Investigators

• Principal Investigator: Yi Lu, Sports Medicine Service, Beijing Jishuitan hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi Lu, Director of Sports Medicine Service of Beijing Jishuitan hospital, Beijing Jishuitan Hospital
• ClinicalTrials.gov Identifier: NCT04556825
• Other Study ID Numbers: YiL
• First Posted: Sep 21, 2020
• Last Update Posted: Sep 21, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tennis Elbow

Study Results

No Results Posted as of Sep 21, 2020