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

NCT05742061 | Unknown Early Phase 1 DMC

• 1 other identifier: MS 54-1-2023
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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

• Assessment of knee pain, stiffness and physical function 2 weeks after injection

  Assessment through WOMAC score

  2 weeks after injection

• Assessment of knee pain, stiffness and physical function 6 weeks after injection

  Assessment through WOMAC score

  6 weeks after injection

• Assessment of knee pain, stiffness and physical function 12 weeks after injection

  Assessment through WOMAC score

  12 weeks after injection

Study Arms (2)

OA group injected by corticosteroid

ACTIVE COMPARATOR

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

Drug: Corticosteroid

OA group injected by Platelet Rich Plasma

ACTIVE COMPARATOR

Group lI include 50 patients who will be injected with a single 5 ml intra\_articular injection of PRP prepared in our hospital

Other: Platelet Rich Plasma

Interventions

Corticosteroid 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 corticosteroid

Platelet Rich Plasma 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.

OA group injected by Platelet Rich Plasma

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: Patients 40-70 years of age suffering from knee OA
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Arwa S. Amer, MD

CONTACT

01550465282; arwa.amer@fmed.bu.edu.eg

Benha University

CONTACT

0133213517; info@bu.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Rheumatology, Rehabilitation and Physical Medicine

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 23, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share