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

NCT07828561 | Completed

• 1 other identifier: KIST-PRP-OA-079/80/38
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Osteoarthritis (OA); Degenerative Joint Disease of Knee; Knee Pain

Keywords

Osteoarthritis; knee pain; Platelet rich plasma; PRP; Regenerative Therapy; WOMAC; VAS

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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).

  Baseline to 6 months

• Functional outcome

  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).

  Baseline to 6 months

Study Arms (1)

PRP Injection

EXPERIMENTAL

All participants received a single intraarticular injection of 5 ml leukocyte-poor platelet-rich plasma (PRP). The PRP was prepared using a double-spin centrifugation protocol and injected via an inferolateral approach with the knee flexed to 70°. Post-injection care included ice fomentation and range of motion exercises. NSAIDs were avoided for 2 days before and after injection; paracetamol was permitted for pain relief.

Biological: Platelet-Rich Plasma (PRP)

Interventions

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.

PRP Injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KIST Medical and Teaching Hospital: lead

Study Sites (1)

KIST Medical College and Teaching Hospital

Lalitpur, Nepal

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Consultant and Clinical Researcher, Principal Investigator

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 18, 2026
• Study Start: November 5, 2022
• Primary Completion: November 5, 2023
• Study Completion: November 5, 2023
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: Data will be available upon reasonable request to the Principal Investigator. Requests must include a research proposal and data use agreement. Approved requests will receive access via a secure repository.

Locations

NE (1)