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

Cartilage Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082531
• Other study ID #: KY20232210
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Xijing Hospital
• Contact: Yanyan Jia
• Phone: +862984771794
• Email: xiyyllwyh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cartilage Injury
• Meniscus Disorder
• Osteoarthritis
• Osteoarthritis Knees Both
• Osteoarthritis, Knee
• Wounds and Injuries

Intervention

Drug:
• Sodium hyaluronate injection
The control group was injected into the joint cavity with sodium hyaluronate injection..

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-operation,3 weeks after treatment, 6 months after treatment
Primary	CT	The application of three-dimensional CT scan for the assessment of articular cartilage defects.	pre-operation,3 weeks after treatment, 6 months after treatment
Primary	MRI	The injury of ligaments, meniscus, and the knee joint was assessed using MRI.	pre-operation,3 weeks after treatment, 6 months after treatment