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

NCT ID: NCT03329235

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-01-01

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intraosseous and intra-articular

injection of PRP 2 ml

Group Type EXPERIMENTAL

PRP

Intervention Type DRUG

platelet rich plasma

intra-articular PRP

injection PRP 2 ml

Group Type ACTIVE_COMPARATOR

PRP

Intervention Type DRUG

platelet rich plasma

Intra-articular injection of HA

injection of HA 2 ml

Group Type ACTIVE_COMPARATOR

HA

Intervention Type DRUG

hyaluronic acid

Interventions

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PRP

platelet rich plasma

Intervention Type DRUG

HA

hyaluronic acid

Intervention Type DRUG

Eligibility Criteria

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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.
* BMI \>32.
* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cangzhou Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Cangzhou Central Hospital

Identifier Type: -

Identifier Source: org_study_id