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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Meir Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01422460
First received: August 14, 2011
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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 Intervention
Osteoarthritis of Subtalar Joint
Biological: Platelet Rich Plasma

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Improvement in function and activity level in subtalar joint with osteoarthritis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    function and activity levels -be leveled according to ANKLE HINDFOOT SCORE 1-100

  • improvement in pain in subtalar osteoarthritis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    pain will be leveled according to VAS SCORE:1-10 POINTS (10 THE MOST IN PAIN)


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

TREATMENT PROCEDURES AND FOLLOW UP VISITS CLINICAL-RADIOLOGICAL ASSESSMENT

  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01422460

Contacts
Contact: Lior Laver, M.D : +972-50-8464466 laver17@gmail.com

Locations
Israel
Meir medical center Not yet recruiting
Kfar Saba, Israel
Contact: Lior Laver, M.D    +972-50-8464466    laver17@gmail.com   
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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01422460     History of Changes
Other Study ID Numbers: MMC11003011CTIL
Study First Received: August 14, 2011
Last Updated: August 23, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Osteoarthritis
PRP
PRGF

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014