The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of Subtalar Joint||Biological: Platelet Rich Plasma||Not Applicable|
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
- 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.
- The screening form :VAS SCORE and ANKLE-HINDFOOT SCORE will be completed-
- Demographic data: date of birth, sex, age and complete medical history, weight, height and previous treatments will be recorded.
- Clinical examination will be performed.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2013|
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
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422460
|Contact: Lior Laver, M.D||: +firstname.lastname@example.org|
|Meir medical center||Not yet recruiting|
|Kfar Saba, Israel|
|Contact: Lior Laver, M.D +972-50-8464466 email@example.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|