Clinical trial

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

Name
KY20232210
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
Sodium hyaluronate injection
The control group was injected into the joint cavity with sodium hyaluronate injection..
Arms:
postoperative (3 months), postoperative (6 weeks)
Size
300
Primary endpoint
X-ray
pre-operation,3 weeks after treatment, 6 months after treatment
CT
pre-operation,3 weeks after treatment, 6 months after treatment
MRI
pre-operation,3 weeks after treatment, 6 months after treatment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-10-13

1 organization

1 product

4 indications

Organization
Xijing Hospital