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

Primary Purpose

Platelets-rich Plasma, Osteoarthritis Knees Both, Meniscus Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium hyaluronate injection
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platelets-rich Plasma focused on measuring platelets-rich plasma, Osteoarthritis, Cartilage Injury, Meniscus Injury

Eligibility Criteria

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

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.

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Preoperative

postoperative (6 weeks)

postoperative (3 months)

Arm Description

The patients were injected with PRP.

The patients were injected with PRP.

Outcomes

Primary Outcome Measures

X-ray
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
CT
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
MRI
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06082531
Brief Title
Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
Official Title
Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelets-rich Plasma, Osteoarthritis Knees Both, Meniscus Disorder, Cartilage Injury
Keywords
platelets-rich plasma, Osteoarthritis, Cartilage Injury, Meniscus Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative
Arm Type
No Intervention
Arm Title
postoperative (6 weeks)
Arm Type
Experimental
Arm Description
The patients were injected with PRP.
Arm Title
postoperative (3 months)
Arm Type
Experimental
Arm Description
The patients were injected with PRP.
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate injection
Intervention Description
The control group was injected into the joint cavity with sodium hyaluronate injection..
Primary Outcome Measure Information:
Title
X-ray
Description
The postoperative plain X-ray film was utilized for the assessment of knee joint deformity, stenosis of the joint space, and hyperplasia of osteophytes.
Time Frame
pre-operation,3 weeks after treatment, 6 months after treatment
Title
CT
Description
The application of three-dimensional CT scan for the assessment of articular cartilage defects.
Time Frame
pre-operation,3 weeks after treatment, 6 months after treatment
Title
MRI
Description
The injury of ligaments, meniscus, and the knee joint was assessed using MRI.
Time Frame
pre-operation,3 weeks after treatment, 6 months after treatment

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanyan Jia
Phone
+862984771794
Email
xiyyllwyh@163.com
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanyan Jia
Phone
+862984771794
Email
xiyyllwyh@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36326886
Citation
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.
Results Reference
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PubMed Identifier
34414200
Citation
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.
Results Reference
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Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis

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