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

NCT ID: NCT05742061

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2023-12-31

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.

Conditions

Osteoarthritis Knee; Corticosteroid; Platelet Rich Plasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OA group injected by 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

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

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.

OA group injected by 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

Group Type: ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Arwa El Sayed Abdel Rahman

Lecturer of Rheumatology, Rehabilitation and Physical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Arwa S. Amer, MD

Role: CONTACT

arwa.amer@fmed.bu.edu.eg

01550465282

Benha University

Role: CONTACT

info@bu.edu.eg

0133213517

Other Identifiers

MS 54-1-2023

Identifier Type: -

Identifier Source: org_study_id