The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 14, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 24, 2011
August 1, 2011
10 months
August 14, 2011
August 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement in function and activity level in subtalar joint with osteoarthritis
function and activity levels -be leveled according to ANKLE HINDFOOT SCORE 1-100
1 year
improvement in pain in subtalar osteoarthritis
pain will be leveled according to VAS SCORE:1-10 POINTS (10 THE MOST IN PAIN)
1 year
Study Arms (1)
Platelet Rich Plasma
EXPERIMENTALintra articular injection 2ml of platelet-derived preparation rich in growth factors
Interventions
Platelet Rich Plasma (Preparation Rich in Growth Factors) intra articular injection 2ml Arms: Platelet Rich Plasma (Preparation Rich in Growth Factors)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir medical center
Kfar Saba, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2011
First Posted
August 24, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
August 24, 2011
Record last verified: 2011-08