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

Osteoarthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05742061
• Other study ID #: MS 54-1-2023
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Benha University
• Contact: Arwa S. Amer, MD
• Phone: 01550465282
• Email: arwa.amer[@]fmed.bu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corticosteroid
• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee
• Platelet Rich Plasma

Intervention

Drug:
• Corticosteroid
The injection will be given at a site near the superolateral pole of patella in the suprapatellar pouch under aseptic conditions and the patient will be advised to take one day of rest after injection and apply ice to the area if there are any signs of inflammation.

Other:
• Platelet Rich Plasma
PRP preparation :- 20 ml of venous blood will be drawn from the antecubital vein using an 18G needle to avoid traumatizing platelets and will be collected in a sterile tube containing 2 ml of Sodium Citrate anticoagulant. Approximately 2 ml of whole blood will be separated for a complete blood count.The blood with anticoagulant will centrifuged at 4000 rpm for 6-10 minutes to separate erythrocytes and then at 4000 rpm for 6-10 min to concentrate platelets.The final product was 4-5 ml of PRP containing leukocytes with platelet concentration of 3-5 times the average normal value.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of knee pain, stiffness and physical function prior knee 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 will be done just before injection
Primary	Assessment of knee pain, stiffness and physical function 2 weeks after injection	Assessment through WOMAC score	2 weeks after injection
Primary	Assessment of knee pain, stiffness and physical function 6 weeks after injection	Assessment through WOMAC score	6 weeks after injection
Primary	Assessment of knee pain, stiffness and physical function 12 weeks after injection	Assessment through WOMAC score	12 weeks after injection