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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01926327
First received: August 17, 2013
Last updated: April 24, 2014
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Biological: PRP injection
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • pain [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection

  • physical activity [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    physical activity of patients which is measured by WOMAC scoring , before injection of PRP& 3,6 and 12 months after last injection.

  • cartilage repair [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
    The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.


Secondary Outcome Measures:
  • quality of life [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
    Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.

  • joint replacement [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
    Evaluation the need for joint replacement 12months after injection.


Enrollment: 150
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: platelet reach plasma
The patients with osteoarthritis who underwent PRP injection.
Biological: PRP injection
Injection of PRP in patients with knee osteoarthritis.
Placebo Comparator: placebo
The patients with osteoarthritis who underwent Normal Saline injection.
Biological: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926327

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01926327     History of Changes
Other Study ID Numbers: royan-Bone-011
Study First Received: August 17, 2013
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
PRP PRGF Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014