The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee

April 24, 2014 updated by: Royan Institute

The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)

Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.

The current treatments which are already being used for osteoarthritis of the knee patients include:

  1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
  2. Intra-articular injections of corticosteroids and hyaluronic acid.
  3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.

As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.

PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.

This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee

Study Overview

Status

Completed

Conditions

Detailed Description

In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.

All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.

Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 65 years
  2. Body mass index (BMI) ≤33 kg/m2
  3. Grade 2And above imaging of osteoarthritis
  4. History of knee pain or swelling should have at least 4 months

Exclusion Criteria:

  1. treated with steroids and Anti-coagulant or anti-platelet aggregation
  2. history of infectious, systemic diseases, Immune deficiency and coagulation disorders
  3. Patients with Hb ≤11, Plt ≤ 150000
  4. Varus > 10 , valgus > 10

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: platelet reach plasma
The patients with osteoarthritis who underwent PRP injection.
Injection of PRP in patients with knee osteoarthritis.
Placebo Comparator: placebo
The patients with osteoarthritis who underwent Normal Saline injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: 3 months
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
3 months
physical activity
Time Frame: 3months
physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.
3months
cartilage repair
Time Frame: 12months
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
12months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: 3months
Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
3months
joint replacement
Time Frame: 12months
Evaluation the need for joint replacement 12months after injection.
12months

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Nasser Aghdami, MD,PhD, Head of Department of Regenerative Medicine Of Royan Institute & cell therapy center
  • Study Director: Mohsen Emadedin, MD, Orthoped scientist in Royan Institute
  • Principal Investigator: Ali Mirazimi Bafghi, MD, Regenerative Medicine Department of Royan Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 17, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • royan-Bone-011

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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