Intra-articular Platelet Rich Plasma vs Corticosteroid in Treatment of Knee Osteoarthritis Patients

Early Phase 1

Not yet recruiting

• Conditions: Platelet Rich Plasma; Corticosteroid; Osteoarthritis Knee
• Interventions: Other: Platelet Rich Plasma; Drug: Corticosteroid

• Registration Number: NCT05742061
• Lead Sponsor: Benha University

Brief Summary

Knee osteoarthritis is the most common type of osteoarthritis in the lower extremity and constitutes 23% of all arthritis cases, about 13% of females and 10% of males aged above 60 years have symptomatic knee OA. Intra-articular corticosteroids (IACs) are a frequently-used treatment regimen for pain relief from symptomatic knee OA as it inhibits inflammation and reduces prostaglandin synthesis. Platelet-rich plasma (PRP) is an autologous blood product containing a high percentage of various growth factors (GFs), such as fibroblast growth factor, epidermal growth factor, vascular endothelial growth factor, transforming growth factor-β and platelet-derived growth factor. The aim of this study is to compare effect of intra-articular injection of platelet rich plasma versus corticosteroid in treatment of primary knee osteoarthritis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-02-23
• Last Update Posted: 2023-02-23
• Study Start: 2023-04
• Primary Completion: 2023-10
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients 40-70 years of age suffering from knee OA with Kellgren Lawrence grade II or III on standing antero-posterior and lateral knee radiographs.
• Patients diagnosed according to ACR classification criteria.

Exclusion Criteria

• Systemic diseases as Patients having diabetes mellitus,Cardiovascular diseases or coagulopathies.
• Those receiving treatment with anticoagulant , anti_platelet medications or systemic corticosteroid 10 days before injection or recent use of NSAIDs.
• Pregnant and breast feeding females.
• Patients have hemoglobin values <10 g/dl or platelet values<150,000/ml.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OA group injected by Platelet Rich Plasma	Platelet Rich Plasma	Group lI include 50 patients who will be injected with a single 5 ml intra_articular injection of PRP prepared in our hospital
OA group injected by corticosteroid	Corticosteroid	Group l include 50 patients who will be injected with one intra_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine

Primary Outcome Measures

Name	Time	Method
Assessment of knee pain, stiffness and physical function 6 weeks after injection	6 weeks after injection	Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function 12 weeks after injection	12 weeks after injection	Assessment through WOMAC score
Assessment of knee pain, stiffness and physical function prior knee injection	Assessment will be done just before injection	Assessment through the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. The final score for the WOMAC was determined by adding the aggregate scores for pain, stiffness, and function. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
Assessment of knee pain, stiffness and physical function 2 weeks after injection	2 weeks after injection	Assessment through WOMAC score