Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04556825
• Other study ID #: YiL
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Beijing Jishuitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• PRP
• Tennis Elbow

Intervention

Drug:
• PRP
After the arthroscopic operation was completed, a local PRP with 4ml was injected
• normal saline
After the arthroscopic operation was completed, a local normal saline injection with same ml was performed

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Integrity of the tendon in MRI	MRI was performed to identify the status of the tendon	3, 6, 12, 24 months postoperatively
Secondary	Disability of the Arm, Shoulder, and Hand (DASH)	A score used to evaluated the elbow function, higher scores mean a worse outcome.	3, 6 weeks and 3, 6, 12, 24months postoperatively
Secondary	Patient-Rated Tennis Elbow Evaluation (PRTEE) scale	A score used to evaluated the elbow function, higher scores mean a worse outcome	3, 6 weeks and 3, 6, 12, 24months postoperatively
Secondary	scoring system of Verhaar	A score used to evaluated the elbow function, higher scores mean a better outcome	3, 6 weeks and 3, 6, 12, 24months postoperatively
Secondary	visual analog scale (VAS)	A score used to evaluated the elbow function, higher scores mean a better	3, 6 weeks and 3, 6, 12, 24months postoperatively