Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
Primary Purpose
PRP, Lateral Epicondylitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for PRP
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study group
Control group
Arm Description
Arthroscopic treatment with PRP injection
Arthroscopic treatment with normal saline injection
Outcomes
Primary Outcome Measures
Mayo Elbow Performance Score
A score used to evaluated the elbow function
Integrity of the tendon in MRI
MRI was performed to identify the status of the tendon
Secondary Outcome Measures
Full Information
NCT ID
NCT04556825
First Posted
September 15, 2020
Last Updated
September 15, 2020
Sponsor
Beijing Jishuitan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04556825
Brief Title
Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
Official Title
Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Jishuitan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PRP, Lateral Epicondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Arthroscopic treatment with PRP injection
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Arthroscopic treatment with normal saline injection
Intervention Type
Drug
Intervention Name(s)
PRP
Intervention Description
After the arthroscopic operation was completed, a local PRP injection was performed
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
After the arthroscopic operation was completed, a local normal saline injection was performed
Primary Outcome Measure Information:
Title
Mayo Elbow Performance Score
Description
A score used to evaluated the elbow function
Time Frame
1 year postoperatively
Title
Integrity of the tendon in MRI
Description
MRI was performed to identify the status of the tendon
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhijun Zhang, M.D.
Phone
+86 15201277648
Email
zzj5285029@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Lu
Organizational Affiliation
Sports Medicine Service, Beijing Jishuitan hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Randomized Controlled Study on Arthroscopic Treatment Combined With PRP Injection for Refractory Elbow Epicondylitis
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