Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

NCT ID: NCT04556825

Last Updated: 2024-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-07-01

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.

Detailed Description

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Conditions

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PRP Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Study group

Arthroscopic treatment with PRP injection

Group Type EXPERIMENTAL

PRP

Intervention Type DRUG

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

Control group

Arthroscopic treatment with normal saline injection

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

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PRP

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Jishuitan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Lu

Director of Sports Medicine Service of Beijing Jishuitan hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Lu

Role: PRINCIPAL_INVESTIGATOR

Sports Medicine Service, Beijing Jishuitan hospital

Locations

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Beijing Jishuitan hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40448507 (View on PubMed)

Other Identifiers

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YiL

Identifier Type: -

Identifier Source: org_study_id

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