The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422460
Recruitment Status : Unknown
Verified August 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2011
Last Update Posted : August 24, 2011
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
The investigators will try to find any efficacy of platelet rich plasma injection for the treatment of osteoarthritis (OA) in the subtalar joint. Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in OA capsular joints via multiple mechanisms. The investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(PRGFs) in OA of the subtalar joint, using parameters of pain, function, quality of life and safety.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Subtalar Joint Biological: Platelet Rich Plasma Not Applicable

Detailed Description:

The therapeutic use of autologous platelet-rich plasma (PRP) constitutes a relatively new biotechnology that has been a breakthrough in the stimulation and acceleration of soft-tissue and bone healing In this process PRGF (preparation rich in growth factors) combines the advantage of an autologous fibrin clot that will aid in hemostasis as well as provide growth factors in high concentrations to the site of a tissue defect. The platelet-rich plasma preparation encourages the release and slow delivery of growth factors from harvested platelets, activated by endogenous thrombin, and is used as a biological enhancer in the healing of fractures, lumbar fusions, cartilage defects, muscle tears and tendon lesions, thus promoting initiation and early maturation of bone and soft tissue formation which involves a more physiologic repair with less scar tissue.

Few tubes of whole blood are drowning from the patient in a sterile manner and go through a process of centrifugation and laboratory separation of the different plasma fractions. Then, to derive benefit from the described natural mechanism, Ca2+ is added to plasma enriched in platelets, triggering the formation of a fibrin matrix containing embedded platelets. The resulting PRGF allows the slow release of biologically active proteins that initiate and modulate wound healing in both soft and hard tissues .

The objective of this clinical trial is to evaluate the symptomatic efficacy of PRGF application in the treatment of OA of the Sub-Talar joint.

base on that knowledge here is the protocol briefly:

1st visit: Enrollment of patient

  1. The patient will be given a full verbal and written explanation regarding the trial and treatment. by the investigator . The patient will sign the informed consent form and will be given a serial number.
  2. The screening form :VAS SCORE and ANKLE-HINDFOOT SCORE will be completed-
  3. Demographic data: date of birth, sex, age and complete medical history, weight, height and previous treatments will be recorded.
  4. Clinical examination will be performed.
  5. Blood (4 tubes, 4-5 m"l each) will be drawn from all patients . The blood taken from the PRGF group patients will then be used for the preparation of PRGF.

Intra-Articular injections (PRGF) will then be initiated.


  • Clinical assessment for all patients shall be made on enrollment, and then 4, 12, 26 weeks after enrollment.
  • The clinical assessment will be according to the Ankle- Hindfoot, and the VAS SCORES.
  • The radiological evaluation will be according to Kellgren and lawrence and will be performed on AP and Lateral views of the knee.

Side effect will be monitored at every visit

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Platelet Rich Plasma
intra articular injection 2ml of platelet-derived preparation rich in growth factors
Biological: Platelet Rich Plasma

Platelet Rich Plasma (Preparation Rich in Growth Factors)

intra articular injection 2ml

Arms: Platelet Rich Plasma (Preparation Rich in Growth Factors)

Other Name: Platelet-derived preparation rich in growth factors

Primary Outcome Measures :
  1. Improvement in function and activity level in subtalar joint with osteoarthritis [ Time Frame: 1 year ]
    function and activity levels -be leveled according to ANKLE HINDFOOT SCORE 1-100

  2. improvement in pain in subtalar osteoarthritis [ Time Frame: 1 year ]
    pain will be leveled according to VAS SCORE:1-10 POINTS (10 THE MOST IN PAIN)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female age 18-70
  • Diagnosed OA of subtalar joint
  • Patients who didn't benefit from other conservative treatments
  • Patients who are willing to participate in the trial

Exclusion criteria:

  • Non ambulatory
  • Pregnant or lactating women
  • Patient with containment disease that may affect joint
  • Patient with open wounds; or skin disease; suspected joint infection: in the treated area
  • Patients with a specific condition or poor general health status that will interfere with the functional assessments during the study or who had intraarticular injection or have had surgery within the previous 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422460

Contact: Lior Laver, M.D : +972-50-8464466

Meir medical center Not yet recruiting
Kfar Saba, Israel
Contact: Lior Laver, M.D    +972-50-8464466   
Principal Investigator: Lior Laver, M/D         
Sub-Investigator: Galit Nachoum, M.D         
Sub-Investigator: Meir Nyska, M.D         
Sub-Investigator: Eyal Yaakobi, M.D         
Sub-Investigator: Esical Palmanovitch, M.d         
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Meir Medical Center Identifier: NCT01422460     History of Changes
Other Study ID Numbers: MMC11003011CTIL
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: August 24, 2011
Last Verified: August 2011

Keywords provided by Meir Medical Center:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action