Joint DiseasePhase 4NCT00782197
Autologous Plasma Rich in Growth Factors (PRGF) Treating the Symptomatic Knee OA
A Phase 4 study testing PRGF Intraarticular injection and Hyaluronic Acid Intraarticular injection in people with Joint Disease, run by Biotechnology Institute IMASD at 3 sites in Spain.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Joint Disease
- What is being tested?
- PRGF Intraarticular injection and Hyaluronic Acid Intraarticular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2008to not given
- Phase
- Phase 4
- 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes and aged between 40 and 72 years.
- Diagnosed with osteoarthritis of the knee by radiological image.
- Pain in the joint equal to or greater than 2.5 points in EAV.
- Radiological severity:Value in the Ahlback score 3 or less.
- Body mass index between 20 and 30.
- Possibility for observation during follow-up period.
Who cannot join
- Bilateral Gonarthrosis requiring infiltration in both knees.
- Body mass index greater than 30.
- Diagnosed polyarticular disease.
- Severe mechanical deformation.
- Previous arthroscopy in the past year.
- Intraarticular infiltration of hyaluronic acid in the last 6 months.
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- Rheumatic autoimmune systemic disease.
- Poorly controlled diabetes mellitus.
- Blood alterations.
- Immunosuppressive treatments and/or coumarinics.
- Treatment with steroids for 3 months prior to its inclusion in the study.
- Treatment with nonsteroidal anti-inflammatory drugs for 15 days prior to its inclusion in the study.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Donostia.
Donostia / San Sebastian, Gipuzkoa
Policlinica Gipuzkoa
Donostia / San Sebastian, Gipuzkoa
UCA (Unidad de Cirugía Artroscopica Mikel Sanchez.) Clinica USP La Esperanza.
Vitoria-Gasteiz, Alava
About this study
Official title: Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
The purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
Read the detailed description
Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.
The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
- Conditions
- Joint Disease
- Being tested
- PRGF Intraarticular injection, Hyaluronic Acid Intraarticular injection
- Keywords
- osteoarthritis, knee, PRGF, autologous plasma, plasma preparations, treatment
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF Intraarticular injectionDevice
Three consecutive PRGF injections each one week apart.
Hyaluronic Acid Intraarticular injectionDevice
Three consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PRGF Receives: Device: PRGF Intraarticular injection |
| 2 | Active comparator | Hyaluronic Acid Receives: Device: Hyaluronic Acid Intraarticular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
Measured: 6 months
Secondary outcomes (4)
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
Measured: 6 months
Changes in Quality of life (SF-12 questionnaire).
Measured: 6 months
Changes in Degree of joint mobility.(determined by goniometer).
Measured: 6 months
Complications and/or adverse effects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotechnology Institute IMASD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mikel Sanchez, Principal investigator, UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.Jaime Usabiaga, Study director, Hospital DonostiaJavier Albillos, Study director, Policlinica Gipuzkoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782197
- Sponsor's protocol ID
- BTI-01-EC/07/ART
- Status last verified
- Oct 2010
- First submitted
- 30 Oct 2008
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Infiltration of Autologous Plasma Rich in Growth Factors (PRGF) in the Symptomatic Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00782197
- Acronym / sponsor ID
- BTI-01-EC/07/ART
- Conditions
- Joint Disease
- Keywords
- osteoarthritis, knee, PRGF, autologous plasma, plasma preparations, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Biotechnology Institute IMASDIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- First posted
- 31 Oct 2008 (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 purpose of this study is to evaluate the efficacy and safety of PRGF infiltrations in the treatment of knee osteoarthritis.
Detailed description
Several studies have shown the positive effects of the autologous "Preparation Rich in Growth Factors" (PRGF) in different clinical situations involving connective tissues and also in OA synovial cells. PRGF is a biological delivery system of a complex mixture of bioactive proteins essential to natural repair including anabolic factors for cartilage such as transforming growth factor-β1 (TGF-β1), platelet-derived growth factor (PDGF) and insulin-like growth factor (IGF-I). The potential of PRGF to enhance the limited capacity of cartilage to repair itself encouraged the idea of treating degenerative joint conditions with this autologous preparation.
The present study was undertaken to assess the efficacy and safety of the intra-articular injection of PRGF and to obtain useful information about the clinical effects. Since pain is the most pressing problem facing people with OA, a significant improvement in pain would indicate the potential of the proposed treatment. We will also evaluate functionality and quality of life. In addition we will examine changes in novel serum and synovial fluid biomarkers and their correlation with MRI-based parameters in a subgroup of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: PRGF Intraarticular injectionPRGF |
| 2 | Active comparator | Device: Hyaluronic Acid Intraarticular injectionHyaluronic Acid |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients of both sexes and aged between 40 and 72 years.
- Diagnosed with osteoarthritis of the knee by radiological image.
- Pain in the joint equal to or greater than 2.5 points in EAV.
- Radiological severity:Value in the Ahlback score 3 or less.
- Body mass index between 20 and 30.
Key exclusion criteria (12 listed)
- Bilateral Gonarthrosis requiring infiltration in both knees.
- Body mass index greater than 30.
- Diagnosed polyarticular disease.
- Severe mechanical deformation.
- Previous arthroscopy in the past year.
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 |
|---|---|---|
| PRGF Intraarticular injectionThree consecutive PRGF injections each one week apart. | Device | 1 |
| Hyaluronic Acid Intraarticular injectionThree consecutive Hyaluronic acid (EUFLEXXA) injections, each one week apart. | Device | 2 |
Primary outcome
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index.
Time frame: 6 months
4 secondary outcomes
Improvement of joint function (change in Womac OA index total score and function and stiffness subscores.)
Time frame: 6 months
Changes in Quality of life (SF-12 questionnaire).
Time frame: 6 months
Changes in Degree of joint mobility.(determined by goniometer).
Time frame: 6 months
Complications and/or adverse effects.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2010.
- Related InfoLink provided by the sponsor.
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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.
Mikel Sanchez principal investigator
UCA (Unidad de Cirugía Artroscópica Mikel Sanchez). USP Clínica la Esperanza. C/LA Esperanza 3, 01002 Vitoria (Alava)SPAIN.
Jaime Usabiaga study director
Hospital Donostia
Javier Albillos study director
Policlinica Gipuzkoa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRGF Intraarticular injection and Hyaluronic Acid Intraarticular injection in people with Joint Disease, run by Biotechnology Institute IMASD at 3 sites in Spain.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Womac pain subscore and visual analogue score from baseline and changes in Lequesne's algofunctional index. (time frame: 6 months). 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 4 Oct 2010.