Comparison of Platelet-rich Plasma and Activated Cytokine-rich Serum Injection Treatments in Patients With Knee Osteoarthritis. (KOA PRP ACS)

Pamukkale University

Status: Not yet enrolling

Conditions: Conditioned Serum; Knee Arthritis Osteoarthritis; Platelet Rich Plasma Injection

Treatments: Drug: Autologous Platelet-Rich Plasma (PRP); Drug: Conditioned serum (CS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07473232

2025TIPF037 (Other Grant/Funding Number)

E-60116787-020- 61586

Details and patient eligibility

About

The effects of single dose injection of platelet rich plasma or conditioned serum in the knee joint in patients with knee osteoarthritis will be compared

Full description

Patients with early grade bilateral knee osteoarthritis (Kellgren Lawrence grade 1 or 2) will be divided into 2 groups. One group of patients will be injected with single dose of autologous platelet rich plasma (PRP) in the knee joints. Other group of patients will be injected with eqiuvolume of autologous conditioned serum (CS) (also known as activated cytokine rich serum) in the knee joints. Patients' serum before injection, the treatment product (PRP and CS), patients serum 30 min after injection will be investigated for IL-1β, IL-1Ra, PDGF-BB, IGF-1, TGF-β and TNF-α. Patients' serum 1 week and 1 month after injection will be investigated for MMP-13, COMP by ELISA. Patients will also be investigated for visual pain scale, WOMAC (Western Ontorino and Mc Master) scale range of motion, ultrasonographic tibiofemoral cartilage thickness measurement and functional tests including the 30-second chair test, stair climb test, 40 meter fast paced walk test, timed up and go test, 6-minute walk test, and walking speed in the first week, first month and third month after injection.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of knee osteoarthritis according to ACR criteria at least 6 months ago.
2. Being between grade 1-2 according to the Kellgren-Lawrence radiological classification.
3. Not having had PRP injection in the last year.
4. Knee pain ≥ 5 according to the visual pain scale.

Exclusion criteria

1. Those with significant neurological or cardiovascular disorders.

2. Those with active thrombovascular disease.

3. Those with joint or skin infections.

4. Those who have recently had an infectious disease.

5. Those infected with Hepatitis B, C, and HIV.

6. Those who have received intra-articular knee injections (hyaluronic acid, PRP, corticosteroids, and others) within the last year.

7. Those who use oral corticosteroids.

8. Those who have used NSAIDs within the last week.

9. Those who have used anti-platelet or anti-aggregant drugs within the last week.

10. Those with coagulation disorders.

11. Those with hemoglobin <10 g/dl and platelet count <100,000

12. Those with cancer.

13. Pregnant or breastfeeding women, drug addicts.

14. Those scheduled for knee surgery or arthroscopy, or those who have undergone knee surgery or arthroscopy.

15. Those with diseases causing secondary osteoarthritis:

    1. post-traumatic,

    2. congenital or developmental diseases

       1. Local diseases (leg length discrepancy, varus, valgus deformities, hypermobility syndromes, scoliosis)
       2. Generalized diseases (Bone dysplasias, Metabolic disorders (hemochromatosis, ochronosis, Gaucher disease, hemoglobinopathy, Ehlers-Danlos disease))

    3. Calcium storage diseases (calcium pyrophosphate storage disease, etc.)

    4. Other bone and joint diseases (avascular necrosis, rheumatoid arthritis, gouty arthritis, septic arthritis, Paget's disease, osteoporosis, osteochondritis)

    5. Other diseases

       1. Endocrine diseases (Diabetes mellitus, acromegaly, hypothyroidism, hyperthyroidism)
       2. Neuropathic arthropathy (Charcot joint)
       3. Other (Frost, Kashin-Beck disease, Caisson disease) -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

PRP group

Experimental group

Description:

patients with knee osteoarthritis who will be injected with autologous PRP

Treatment:

Drug: Autologous Platelet-Rich Plasma (PRP)

conditioned serum group

Experimental group

Description:

patients with knee osteoarthritis who will be injected with autologous conditioned serum

Treatment:

Drug: Conditioned serum (CS)