The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kfar Saba, Israel
- Meir Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Platelet Rich Plasma
intra articular injection 2ml of platelet-derived preparation rich in growth factors
|
Platelet Rich Plasma (Preparation Rich in Growth Factors) intra articular injection 2ml Arms: Platelet Rich Plasma (Preparation Rich in Growth Factors)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
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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)
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MMC11003011CTIL
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