Knee OsteoarthritisPhase 4NCT03211650
Efficacy of Hyaluronic Acid and Platelet-rich Plasma Combination in Knee Osteoarthritis
A Phase 4 study testing hyaluronic Acid + platelet-rich plasma, hyaluronic acid and platelet-rich plasma in people with Knee Osteoarthritis, run by University of Milan at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- hyaluronic Acid + platelet-rich plasma, hyaluronic acid and platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesItaly
- Study dates
- 14 Oct 2016to 27 Mar 2021
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain for 4 months;
- Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
- Patients able to understand the study conditions and willing to participate for its entire duration;
- Patients who signed written informed consent.
Who cannot join
- Severe knee osteoarthritis of grade 4;
- Diabetes mellitus;
- Rheumatoid arthritis;
- Ongoing malignancies;
- Certified allergic reactions towards the administered drugs ;
- Malalignment of mechanical axis of the lower limb (varus > 10 °, valgus > 10 °);
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- Coagulopathies;
- Severe cardiovascular diseases;
- Ongoing infections;
- Immunodepression;
- Anticoagulants or anti-platelet agents;
- Haemoglobin < 11 g/dl;
- Platelet count < 150,000/mm^3
- Drug addiction;
- Alcoholism;
- Psychiatric disease;
- Pregnancy or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Milan, 20122
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
About this study
Official title: Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease
The purpose of this study is to evaluate the efficacy of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- hyaluronic Acid + platelet-rich plasma, hyaluronic acid, platelet-rich plasma
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyaluronic Acid + platelet-rich plasmaDrug
Also called Cellular Matrix/A-CP HA Kit
Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
hyaluronic acidDrug
Also called ArthroVisc40
Intra-articular injections of hyaluronic acid
platelet-rich plasmaDrug
Also called RegenKit-BCT-1
Intra-articular injections of platelet-rich plasma
| Study group | Role | What they receive |
|---|---|---|
| hyaluronic acid + platelet-rich plasma | Experimental | Intra-articular injections of hyaluronic acid combined with platelet-rich plasma Receives: Drug: hyaluronic Acid + platelet-rich plasma |
| platelet-rich plasma | Active comparator | Intra-articular injections of platelet-rich plasma Receives: Drug: platelet-rich plasma |
| hyaluronic acid | Active comparator | Intra-articular injections of hyaluronic acid Receives: Drug: hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC score
Comparison of WOMAC total score among three treatment arms
Measured: 6 months after the first intra-articular injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start14 Oct 2016
- Primary completion30 Nov 2018
- Study completion27 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Regen Lab SA
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
- Investigators
- Pietro Randelli, Professor, Principal investigator, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211650
- Sponsor's protocol ID
- ACP-HA
- Status last verified
- Jun 2021
- First submitted
- 6 Jul 2017
- Last updated
- 14 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-articular Injection of Combined Hyaluronic Acid and Platelet-rich Plasma in Knee Degenerative Joint Disease
- ClinicalTrials.gov ID
- NCT03211650
- Acronym / sponsor ID
- ACP-HA
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Regen Lab SA
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 27 Mar 2021 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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 of intra-articular injections of combined hyaluronic acid and platelet-rich plasma in knee degenerative joint disease in improving joint function and reducing pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hyaluronic acid + platelet-rich plasma | Experimental | Drug: hyaluronic Acid + platelet-rich plasmaIntra-articular injections of hyaluronic acid combined with platelet-rich plasma |
| platelet-rich plasma | Active comparator | Drug: platelet-rich plasmaIntra-articular injections of platelet-rich plasma |
| hyaluronic acid | Active comparator | Drug: hyaluronic acidIntra-articular injections of hyaluronic acid |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee pain for 4 months;
- Knee degenerative sign evaluated with X-ray with a Kellgren-Lawrence grade inferior to 3;
- Patients able to understand the study conditions and willing to participate for its entire duration;
- Patients who signed written informed consent.
Key exclusion criteria (17 listed)
- Severe knee osteoarthritis of grade 4;
- Diabetes mellitus;
- Rheumatoid arthritis;
- Ongoing malignancies;
- Certified allergic reactions towards the administered drugs ;
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 |
|---|---|---|
| hyaluronic Acid + platelet-rich plasmaAlso: Cellular Matrix/A-CP HA KitIntra-articular injections of hyaluronic acid combined with platelet-rich plasma | Drug | hyaluronic acid + platelet-rich plasma |
| hyaluronic acidAlso: ArthroVisc40Intra-articular injections of hyaluronic acid | Drug | hyaluronic acid |
| platelet-rich plasmaAlso: RegenKit-BCT-1Intra-articular injections of platelet-rich plasma | Drug | platelet-rich plasma |
Primary outcome
WOMAC score
Time frame: 6 months after the first intra-articular injection
Comparison of WOMAC total score among three treatment arms
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 14 Jun 2021.
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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.
Pietro Randelli, Professor principal investigator
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
2 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 hyaluronic Acid + platelet-rich plasma, hyaluronic acid and platelet-rich plasma in people with Knee Osteoarthritis, run by University of Milan at 2 sites in Italy.
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 17 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
WOMAC score (time frame: 6 months after the first intra-articular injection). 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 14 Jun 2021.