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Not yet recruiting NCT07473232

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

No phase Interventional Knee Arthritis Osteoarthritis Platelet Rich Plasma Injection Conditioned Serum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Platelet-Rich Plasma (PRP), Conditioned serum (CS).
Who it may be relevant to
Registry conditions: Knee Arthritis Osteoarthritis, Platelet Rich Plasma Injection, Conditioned Serum. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Drug Autologous Platelet-Rich Plasma (PRP)
    Autologous Platelet-Rich Plasma (PRP) will be injected intra-articularly in patients with knee osteoarthritis
  • Drug Conditioned serum (CS)
    Autologous conditionedserum (CS) will be injected intra-articularly in patients with knee osteoarthritis

Primary outcome measures

  • Visual pain scale score [Time frame: Visual pain scale score (min 0-max 10) will be measured at the beginning ofthe study, 1 week, 1month and 3 months after the injection.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Those with significant neurological or cardiovascular disorders.
  • Those with active thrombovascular disease.
  • Those with joint or skin infections.
  • Those who have recently had an infectious disease.
  • Those infected with Hepatitis B, C, and HIV.
  • Those who have received intra-articular knee injections (hyaluronic acid, PRP, corticosteroids, and others) within the last year.
  • Those who use oral corticosteroids.
  • Those who have used NSAIDs within the last week.
  • Those who have used anti-platelet or anti-aggregant drugs within the last week.
  • Those with coagulation disorders.
  • Those with hemoglobin <10 g/dl and platelet count <100,000
  • Those with cancer.
  • Pregnant or breastfeeding women, drug addicts.
  • Those scheduled for knee surgery or arthroscopy, or those who have undergone knee surgery or arthroscopy.
  • Those with diseases causing secondary osteoarthritis:
  • post-traumatic,
  • congenital or developmental diseases
  • Local diseases (leg length discrepancy, varus, valgus deformities, hypermobility syndromes, scoliosis)
  • Generalized diseases (Bone dysplasias, Metabolic disorders (hemochromatosis, ochronosis, Gaucher disease, hemoglobinopathy, Ehlers-Danlos disease))
  • Calcium storage diseases (calcium pyrophosphate storage disease, etc.)
  • Other bone and joint diseases (avascular necrosis, rheumatoid arthritis, gouty arthritis, septic arthritis, Paget's disease, osteoporosis, osteochondritis)
  • Other diseases
  • Endocrine diseases (Diabetes mellitus, acromegaly, hypothyroidism, hyperthyroidism)
  • Neuropathic arthropathy (Charcot joint)
  • Other (Frost, Kashin-Beck disease, Caisson disease) -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07473232 · E-60116787-020- 61586 · 2025TIPF037

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗