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Clinical Trials/NCT03329235
NCT03329235
Completed
Early Phase 1

Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis

Cangzhou Central Hospital0 sites86 target enrollmentJanuary 1, 2015
InterventionsPRPHA
DrugsPRPHA

Overview

Phase
Early Phase 1
Intervention
PRP
Conditions
Osteoarthritis, Knee
Sponsor
Cangzhou Central Hospital
Enrollment
86
Primary Endpoint
WOMAC scores
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).

Detailed Description

Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
January 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Unilateral symptomatic knee with pain for at least 1 month or swelling.
  • Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
  • Age 40-73 years.
  • Body mass index (BMI) 18-32.5).
  • Knee stability without a severe trauma history.

Exclusion Criteria

  • Bilateral knee osteoarthritis indicative of treatment for both knees.
  • Kellgren-Lawrence score greater than III.
  • Age \>73 years.
  • Systemic autoimmune rheumatic diseases and blood disorders.
  • Active immunosuppressive or anticoagulant therapy.
  • Intra-articular injection to the knee within the previous 1 year or previous joint infection.
  • use of corticosteroids for 3 weeks before the procedure.
  • use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.

Arms & Interventions

Intraosseous and intra-articular

injection of PRP 2 ml

Intervention: PRP

intra-articular PRP

injection PRP 2 ml

Intervention: PRP

Intra-articular injection of HA

injection of HA 2 ml

Intervention: HA

Outcomes

Primary Outcomes

WOMAC scores

Time Frame: At the 18th month

The evaluation was performed with WOMAC, which were recorded on a five-point Likert scale scoring, with a response of "none" scored as 0, "mild" as 1, "moderate" as 2, "severe" as 3 and "extreme" as 4.

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