Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

NCT04556825 | Active Not Recruiting

• 1 other identifier: YiL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

PRP; Lateral Epicondylitis

Outcome Measures

Primary Outcomes (1)

• Mayo Elbow Performance Score

  A score used to evaluated the elbow function, higher scores mean a better outcome.

  3, 6 weeks and 3, 6, 12, 24 months postoperatively

Secondary Outcomes (5)

• Integrity of the tendon in MRI

  3, 6, 12, 24 months 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

• scoring system of Verhaar

  3, 6 weeks and 3, 6, 12, 24months postoperatively

• visual analog scale (VAS)

  3, 6 weeks and 3, 6, 12, 24months postoperatively

Study Arms (2)

Study group

EXPERIMENTAL

Arthroscopic treatment with PRP injection

Drug: PRP

Control group

PLACEBO COMPARATOR

Arthroscopic treatment with normal saline injection

Drug: normal saline

Interventions

PRP DRUG

After the arthroscopic operation was completed, a local PRP with 4ml was injected

Study group

normal saline DRUG

After the arthroscopic operation was completed, a local normal saline injection with same ml was performed

Control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Jishuitan Hospital: lead

Study Sites (1)

Beijing Jishuitan hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Li S, Yang G, Chen R, Li X, Lu Y. Use of Adjunctive Platelet-Rich Plasma for Healing During Arthroscopic Release and Repair for Recalcitrant Lateral Epicondylitis: A Prospective, Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2025 Jul;53(8):1817-1825. doi: 10.1177/03635465251341458. Epub 2025 May 31.

  PMID: 40448507 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yi Lu

  Sports Medicine Service, Beijing Jishuitan hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)