Skip to main content
OpenTrials
Completed

NCT Number: NCT07828561

Clinical Outcomes of Intraarticular Platelet-Rich Plasma Injection in Knee Osteoarthritis

This prospective single-arm interventional study was designed to assess the short-term clinical outcomes of intra-articular platelet-rich plasma (PRP) injections in patients with Kellgren-Lawrence grade II and III knee osteoarthritis. A total of 59 patients (61 knees) were enrolled and followed for six months. Pain and function were measured using the Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Safety monitoring included documentation of injection-site pain and other adverse events.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Degenerative Joint Disease of Knee Joint Diseases Knee Pain Musculoskeletal Diseases Osteoarthritis Osteoarthritis (OA) Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KIST Medical College and Teaching Hospital

Lalitpur, Nepal

About this study

Osteoarthritis of the knee is a leading cause of disability worldwide. Platelet-rich plasma (PRP) therapy has emerged as a biologic intervention to enhance cartilage repair and reduce inflammation. This study was conducted at KIST Medical College and Teaching Hospital, Lalitpur, Nepal, between November 2022 and November 2023. Patients aged ≥50 years with KL grade II or III knee OA were enrolled. PRP was prepared using a double-spin centrifugation protocol to yield leukocyte-poor PRP, and 5 ml was injected intraarticularly via an inferolateral approach. Outcomes were assessed at baseline, 2, 4, and 6 months using validated instruments (VAS and WOMAC). Adverse events were monitored throughout the follow-up period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >50 years
  • Persistent knee pain >4 weeks (In the case of patients presenting with bilateral knee pain, the knee with more severe symptoms was selected for study purposes.)
  • Patient must have undergone conservative treatment for at least 4 weeks.
  • Radiologically diagnosed as knee osteoarthritis with Kellgren-Lawrence grading scale, grades 2 and 3
  • Primary osteoarthritis of the knee

Exclusion criteria

  • Immunosuppressed patients (Examples: uncontrolled diabetes, HIV, under corticosteroid medication, etc.)
  • History of surgery around the knee joint
  • History of significant knee injury
  • Patients diagnosed with connective tissue disorders, inflammatory disorders of joints, congenital anomalies of the lower extremity, tumors, and metabolic diseases of bone
  • Patients who had received intra-articular steroid injections within the past 6 months
  • Patient who has not attempted conservative treatment.
  • Presence or suspected of infection or ulceration at the injection site.
  • Patients with a platelet count less than 1.5 lakhs/microliters
  • Congenital anomalies of the lower extremity
  • Patients on NSAIDs 2 days before and 2 days after PRP injection.
  • Patients with coexisting backache, hip pain
  • Pregnant or lactating females.
  • Cases where the diagnosis is uncertain.
  • Patients not willing to participate in the study

Treatment and study plan

Platelet-Rich Plasma (PRP)

Biological

Autologous PRP prepared from 16 ml of venous blood using a double-spin centrifugation protocol (first spin ~700 g for 12 minutes, second spin ~1700 g for 7 minutes). The final product was leukocyte-poor PRP with a mean 4.2-fold increase in platelet concentration. A single 5 ml dose was injected intraarticularly via an inferolateral approach using an 18G needle under aseptic precautions.

Primary outcomes

  1. Pain intensity

    Time frame: Baseline to 6 months

    Unabbreviated scale title: Visual Analogue Scale (VAS) for pain

    Range: 0 to 10

    Interpretation: Higher scores indicate worse pain intensity (0 = no pain, 10 = worst imaginable pain).

  2. Functional outcome

    Time frame: Baseline to 6 months

    Unabbreviated scale title: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Range: 0 to 96 (total score)

    Interpretation: Higher scores indicate worse pain, stiffness, and functional limitation (0 = no symptoms, 96 = extreme symptoms).

Sponsors and collaborators

Lead sponsor

KIST Medical and Teaching Hospital

Other

Registry information

Official study title

Prospective Interventional Study on Intraarticular Platelet-Rich Plasma Injection in Patients With Kellgren-Lawrence Grade II and III Knee Osteoarthritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.