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

October 31, 2017 updated by: Cangzhou Central Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous and intra-articular
injection of PRP 2 ml
Drug: PRP
platelet rich plasma
Active Comparator: intra-articular PRP
injection PRP 2 ml
Drug: PRP
platelet rich plasma
Active Comparator: Intra-articular injection of HA
injection of HA 2 ml
Drug: HA
hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the 18th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cangzhou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 30, 2015

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cangzhou Central Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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