Osteoarthritis of the KneePhase 2/3PRPNCT01270412
Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis
A Phase 2/3 study testing Platelet Rich Plasma (Preparation Rich in Growth Factors) and Hyaluronic acid in people with Osteoarthritis of the Knee, run by Meir Medical Center at 1 site in Israel.
Trial summary
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Platelet Rich Plasma (Preparation Rich in Growth Factors) and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2011to Dec 2013
- Phase
- Phase 2/3
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40-75 years old
- diagnosed Oa of the knee more then 1 year
- no knee deformation
Who cannot join
- mental of physical disabilities
- pregnancy
- deformities of the knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.
Read the detailed description
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (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 knee, using parameters of pain, function, quality of life and safety.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Platelet Rich Plasma (Preparation Rich in Growth Factors), Hyaluronic acid
- Keywords
- Osteoarthritis, PRP, PRGF, Hyaluronic acid
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma (Preparation Rich in Growth Factors)Biological
Also called Platelet-derived preparation rich in growth factors
intra articular injection 6ml
Hyaluronic acidDrug
Also called "Arthrease"
Intra articular injections: 20 mg / 2 ml
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (Preparation Rich in Growth Factors) | Experimental | intra articular injection 6ml of platelet-derived preparation rich in growth factors Receives: Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors) |
| Hyaluronic acid | Active comparator | Drug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease Receives: Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors); Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in pain, function, quality of life and activity level in knee osteoarthritis
Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.
Measured: 1 -2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 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 the KneeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Lior Laver, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270412
- Sponsor's protocol ID
- MMC10196-2010CTIL
- Acronym
- PRP
- Status last verified
- Jul 2011
- First submitted
- 20 Dec 2010
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis - A Randomized-Double-Blind Trial
- ClinicalTrials.gov ID
- NCT01270412
- Acronym / sponsor ID
- PRP / MMC10196-2010CTIL
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, PRP, PRGF, Hyaluronic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Jan 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.
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. The aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA of the knee.
Detailed description
Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (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 knee, using parameters of pain, function, quality of life and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (Preparation Rich in Growth Factors) | Experimental | Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors)intra articular injection 6ml of platelet-derived preparation rich in growth factors |
| Hyaluronic acid | Active comparator | Biological: Platelet Rich Plasma (Preparation Rich in Growth Factors), Drug: Hyaluronic acidDrug: hyaluronic acid 20 mg / 2 ml Other Name: Arthrease |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40-75 years old
- diagnosed Oa of the knee more then 1 year
- no knee deformation
Key exclusion criteria (3 listed)
- mental of physical disabilities
- pregnancy
- deformities of the knee
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 Plasma (Preparation Rich in Growth Factors)Also: Platelet-derived preparation rich in growth factorsintra articular injection 6ml | Biological | Hyaluronic acid, Platelet Rich Plasma (Preparation Rich in Growth Factors) |
| Hyaluronic acidAlso: "Arthrease"Intra articular injections: 20 mg / 2 ml | Drug | Hyaluronic acid |
Primary outcome
Improvement in pain, function, quality of life and activity level in knee osteoarthritis
Time frame: 1 -2 years
Improvement in pain, function, quality of life, activity level - using scores adapted to measure these parameters in knee osteoarthritis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
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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.
Lior Laver, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet Rich Plasma (Preparation Rich in Growth Factors) and Hyaluronic acid in people with Osteoarthritis of the Knee, 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 3 inclusion and 3 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 19 Jul 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD (+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 pain, function, quality of life and activity level in knee osteoarthritis (time frame: 1 -2 years). 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 19 Jul 2011.