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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
Beijing Jishuitan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PRP

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 15, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Beijing Jishuitan Hospital
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    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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