Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis

October 9, 2023 updated by: Xijing Hospital

Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury

To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shannxi
      • Xi'an, Shannxi, China, 710034
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
  • The preoperative routine tests and examinations revealed no contraindications.
  • Revised sentence: "Informed consent of the patient

Exclusion Criteria:

  • The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
  • Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
  • In injection site or damage to the skin.
  • Patients with tumors or undergoing radiotherapy and chemotherapy.
  • Pregnant or breastfeeding women.
  • Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
  • Contraindications for MRI、Patients or their families do consent to participate in the study.
  • Other circumstances that render participation in the study unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Preoperative
Experimental: postoperative (6 weeks)
The patients were injected with PRP.
The control group was injected into the joint cavity with sodium hyaluronate injection..
Experimental: postoperative (3 months)
The patients were injected with PRP.
The control group was injected into the joint cavity with sodium hyaluronate injection..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
X-ray
Time Frame: pre-operation,3 weeks after treatment, 6 months after treatment
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
pre-operation,3 weeks after treatment, 6 months after treatment
CT
Time Frame: pre-operation,3 weeks after treatment, 6 months after treatment
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
pre-operation,3 weeks after treatment, 6 months after treatment
MRI
Time Frame: pre-operation,3 weeks after treatment, 6 months after treatment
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.
pre-operation,3 weeks after treatment, 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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