Knee OsteoarthrosisPhase 2NCT02958761
Treatment of Knee Arthrosis With Platelet-derived Growth Factors vs. Hyaluronic Acid.
A Phase 2 study testing intraarticular injections of platelet lysate and hyaluronic acid in people with Knee Osteoarthrosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthrosis
- What is being tested?
- intraarticular injections of platelet lysate and hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified
- no previous OA treatment with local hyaluronic acid or steroid injections
- ife expectancy >1 year
- no ongoing pregnancy
- ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS
- written consent.
Who cannot join
None listed.
About this study
Official title: Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.
Read the detailed description
Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.
Growth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.
Primary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.
- Conditions
- Knee Osteoarthrosis
- Being tested
- intraarticular injections of platelet lysate, hyaluronic acid
- Keywords
- knee arthrosis, platelet-derived growth factors
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular injections of platelet lysateBiological
hyaluronic acidDrug
intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma | Experimental | Patients in the intervention group will receive three autologous PRP plus calcium gluconate (as activator) intraarticular injections at 4-week intervals. Briefly, at the Immunohaematology and Transfusion Service, on each scheduled visit 20 ml of autologous whole blood will be sampled from each patient, 2 ml ACD-A will be added directly the syringe as anticoagulant; finally the vial will be gently centrifuged at 900rpm for 7 minutes. Platelet-rich plasma was collected. The PRP vials plus activator will be immediately shipped to the rehabilitation unit, where intraarticular injection will be performed by an experienced physiatrist. Receives: Biological: intraarticular injections of platelet lysate |
| hyaluronic acid | Active comparator | Patients in the control group will receive three intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals, by the same study staff. Receives: Drug: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month
Measured: Six months after the last infiltration
Secondary outcomes (7)
WOMAC functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lysholm functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Tegner Knee functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
AKS functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lequesne functional scale
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
VAS for pain
multilevel generalized linear models (for panel-data) with interaction between time and treatment group
Measured: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Adverse event
number of patients and knees with adverse event (any); anticipated potential adverse events were infection, anaphylaxis, hematoma
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 posted8 Nov 2016 (estimated)
- Study startAug 2010
- Primary completionJan 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthrosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Lisi, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Claudio Lisi, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958761
- Sponsor's protocol ID
- 28914/2009
- Status last verified
- Nov 2016
- First submitted
- 29 Oct 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Knee Arthrosis: Platelet-derived Growth Factors vs. Hyaluronic Acid. A Phase II-III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02958761
- Acronym / sponsor ID
- 28914/2009
- Conditions
- Knee Osteoarthrosis
- Keywords
- knee arthrosis, platelet-derived growth factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Nov 2016 (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.
Primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.
Detailed description
Intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing.
Growth factors included in PRP could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life.
Primary aim of this trial was to assess, among patients with grade II/III osteoarthrosis of the knee, efficacy (as determined by improvement at MRI 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. Additional objectives were to compare the treatment groups in terms of a number of functional scales (WOMAC, Lysholm, Tegner Knee, Scale, AKS, Lequesne, VAS) and of number of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma | Experimental | Biological: intraarticular injections of platelet lysatePatients in the intervention group will receive three autologous PRP plus calcium gluconate (as activator) intraarticular injections at 4-week intervals. Briefly, at the Immunohaematology and Transfusion Service, on each scheduled visit 20 ml of autologous whole blood will be sampled from each patient, 2 ml ACD-A will be added directly the syringe as anticoagulant; finally the vial will be gently centrifuged at 900rpm for 7 minutes. Platelet-rich plasma was collected. The PRP vials plus activator will be immediately shipped to the rehabilitation unit, where intraarticular injection will be performed by an experienced physiatrist. |
| hyaluronic acid | Active comparator | Drug: hyaluronic acidPatients in the control group will receive three intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals, by the same study staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- grade II/III OA of the knee demonstrated at MRI17,18, according to Shahriaree Classification System - modified
- no previous OA treatment with local hyaluronic acid or steroid injections
- ife expectancy >1 year
- no ongoing pregnancy
- ability to understand and complete clinical and functional scales Lysholm, WOMAC, AKS, VAS
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| intraarticular injections of platelet lysate | Biological | Platelet-rich plasma |
| hyaluronic acidintraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals | Drug | hyaluronic acid |
Primary outcome
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate
Time frame: Six months after the last infiltration
Each knee was improvement, from baseline, by at least one degree the maximum MRI score (Shahriaree Classification System - modified) at 6 month
7 secondary outcomes
WOMAC functional scale
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lysholm functional scale
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Tegner Knee functional scale
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
AKS functional scale
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Lequesne functional scale
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
VAS for pain
Time frame: At baseline (prior to treatment), at 15 days form the last injection, 6 months from the last infiltration and at 1 year
Adverse event
Time frame: 1 year
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 9 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Claudio Lisi, MD principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraarticular injections of platelet lysate and hyaluronic acid in people with Knee Osteoarthrosis, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 0 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy (as determined by improvement at MRI 6 months after the first injection) of intraarticular injections of platelet lysate (time frame: Six months after the last infiltration). 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 9 Nov 2016.