Osteoarthritis of Subtalar JointNCT01422460
The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
A study testing Platelet Rich Plasma in people with Osteoarthritis of Subtalar Joint, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Subtalar Joint
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir medical center
Kfar Saba
Lior Laver, M.D, +972-50-8464466, laver17@gmail.com
Lior Laver, M/D
About this study
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.
Read the 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
- Conditions
- Osteoarthritis of Subtalar Joint
- Being tested
- Platelet Rich Plasma
- Keywords
- Osteoarthritis, PRP, PRGF
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | intra articular injection 2ml of platelet-derived preparation rich in growth factors Receives: Biological: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in function and activity level in subtalar joint with osteoarthritis
function and activity levels -be leveled according to ANKLE HINDFOOT SCORE 1-100
Measured: 1 year
improvement in pain in subtalar osteoarthritis
pain will be leveled according to VAS SCORE:1-10 POINTS (10 THE MOST IN PAIN)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Subtalar JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422460
- Sponsor's protocol ID
- MMC11003011CTIL
- Status last verified
- Aug 2011
- First submitted
- 14 Aug 2011
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Platelets Rich Plasma Injection With PRGF Method in the Treatment for Osteoarthritis of the Subtalar Joint
- ClinicalTrials.gov ID
- NCT01422460
- Acronym / sponsor ID
- MMC11003011CTIL
- Conditions
- Osteoarthritis of Subtalar Joint
- Keywords
- Osteoarthritis, PRP, PRGF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 24 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Biological: Platelet Rich Plasmaintra articular injection 2ml of platelet-derived preparation rich in growth factors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaAlso: Platelet-derived preparation rich in growth factorsPlatelet Rich Plasma (Preparation Rich in Growth Factors) intra articular injection 2ml Arms: Platelet Rich Plasma (Preparation Rich in Growth Factors) | Biological | Platelet Rich Plasma |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Osteoarthritis of Subtalar Joint, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lior Laver, M.D (: +972-50-8464466, laver17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in function and activity level in subtalar joint with osteoarthritis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2011.