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

Sponsor

Benha University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742061

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Knee Corticosteroid Platelet Rich Plasma	Drug: Corticosteroid Other: Platelet Rich Plasma	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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.
Active Comparator: 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	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.

Arm

Intervention/Treatment

Active Comparator: 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

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.

Active Comparator: 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

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.

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arwa El Sayed Abdel Rahman, Lecturer of Rheumatology, Rehabilitation and Physical Medicine, Benha University

ClinicalTrials.gov Identifier:

NCT05742061

Other Study ID Numbers:

MS 54-1-2023

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Feb 23, 2023