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

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ClinicalTrials.gov Identifier: NCT01926327
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE August 17, 2013
First Posted Date  ICMJE August 20, 2013
Last Update Posted Date April 25, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • pain [ Time Frame: 3 months ]
    pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
  • 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.
  • cartilage repair [ Time Frame: 12months ]
    The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01926327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • quality of life [ Time Frame: 3months ]
    Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
  • joint replacement [ Time Frame: 12months ]
    Evaluation the need for joint replacement 12months after injection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
Official Title  ICMJE The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
Brief Summary

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

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: PRP injection
    Injection of PRP in patients with knee osteoarthritis.
  • Biological: Placebo
Study Arms  ICMJE
  • Active Comparator: platelet reach plasma
    The patients with osteoarthritis who underwent PRP injection.
    Intervention: Biological: PRP injection
  • Placebo Comparator: placebo
    The patients with osteoarthritis who underwent Normal Saline injection.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2014)
150
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2013)
244
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01926327
Other Study ID Numbers  ICMJE royan-Bone-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP