- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06082531
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
Status
Recruiting
Intervention / Treatment
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
- Name: Yanyan Jia
- Phone Number: +862984771794
- Email: xiyyllwyh@163.com
Study Locations
-
-
Shannxi
-
Xi'an, Shannxi, China, 710034
- Recruiting
- Xijing Hospital
-
Contact:
- Yanyan Jia
- Phone Number: +862984771794
- Email: xiyyllwyh@163.com
-
-
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.
General Publications
- Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.
- Zhang Y, Xing F, Luo R, Duan X. Platelet-Rich Plasma for Bone Fracture Treatment: A Systematic Review of Current Evidence in Preclinical and Clinical Studies. Front Med (Lausanne). 2021 Aug 3;8:676033. doi: 10.3389/fmed.2021.676033. eCollection 2021.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20232210
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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