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Clinical Trials/NCT06082531
NCT06082531RecruitingNot Applicable

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

Xijing Hospital2 sites in 1 country300 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
300
Locations
2
Primary Endpoint
MRI

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

postoperative (3 months)

Experimental

The patients were injected with PRP.

Intervention: Sodium hyaluronate injection (Drug)

postoperative (6 weeks)

Experimental

The patients were injected with PRP.

Intervention: Sodium hyaluronate injection (Drug)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Xijing Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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