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Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04556825
Enrollment
80
Registered
2020-09-21
Start date
2020-07-01
Completion date
2024-07-01
Last updated
2024-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis, PRP

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.

Interventions

DRUGPRP

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

DRUGnormal saline

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

Sponsors

Beijing Jishuitan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Mayo Elbow Performance Score3, 6 weeks and 3, 6, 12, 24 months postoperativelyA score used to evaluated the elbow function, higher scores mean a better outcome.

Secondary

MeasureTime frameDescription
Integrity of the tendon in MRI3, 6, 12, 24 months postoperativelyMRI was performed to identify the status of the tendon
Disability of the Arm, Shoulder, and Hand (DASH)3, 6 weeks and 3, 6, 12, 24months postoperativelyA score used to evaluated the elbow function, higher scores mean a worse outcome.
Patient-Rated Tennis Elbow Evaluation (PRTEE) scale3, 6 weeks and 3, 6, 12, 24months postoperativelyA score used to evaluated the elbow function, higher scores mean a worse outcome
scoring system of Verhaar3, 6 weeks and 3, 6, 12, 24months postoperativelyA score used to evaluated the elbow function, higher scores mean a better outcome
visual analog scale (VAS)3, 6 weeks and 3, 6, 12, 24months postoperativelyA score used to evaluated the elbow function, higher scores mean a better

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026