Osteoarthritis, KneePhase 4LIPOJOINTNCT03117608
A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee
A Phase 4 study testing injection of autologous micro-fragmented adipose tissue (aMAT) and injection of Platelet-rich Plasma (PRP) in people with Osteoarthritis, Knee, run by Lipogems International spa at 1 site in Italy.
Trial summary
The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- injection of autologous micro-fragmented adipose tissue (aMAT) and injection of Platelet-rich Plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- 24 Feb 2017to 24 Feb 2024
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients provided written informed consent;
- Patients aged between 18 and 75 years;
- Knee symptomatic OA (Kellgren-Lawrence grade 1-4)
- Failure of conservative treatment for at least 3 months;
- Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
- Male or female patients;
- Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.
Who cannot join
- Patients incapable to understanding and will;
- Patients participating in previous, concurrent or not, trials (ongoing or completed within three months);
- Patients surgically treated for the same defect within one year;
- Patients affected by malignancy;
- Patients affected by metabolic or thyroid disorders;
- Patients used to alcohol or drug (medication) abuse;
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- Patients affected by synovitis;
- Varus or valgus misalignment exceeding 15°;
- Body Mass Index > 40;
- Patients with trauma within 6 months pre-operative.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rizzoli Orthopaedic Institute
Bologna, 40136
Maurilio Marcacci, m.marcacci@biomec.ior.it
Giuseppe Filardo, ortho@gfilardo.com
About this study
Official title: A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
Read the detailed description
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59 patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three, six, twelve, and twenty-four months of follow-up.
- Conditions
- Osteoarthritis, Knee
- Being tested
- injection of autologous micro-fragmented adipose tissue (aMAT), injection of Platelet-rich Plasma (PRP)
- Keywords
- OA, aMAT, PRP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of autologous micro-fragmented adipose tissue (aMAT)Biological
adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.
injection of Platelet-rich Plasma (PRP)Biological
injection of platelet-rich plasma
| Study group | Role | What they receive |
|---|---|---|
| AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) | Experimental | injection of aMAT obtained with Lipogems® technology. Receives: Biological: injection of autologous micro-fragmented adipose tissue (aMAT) |
| platelet-rich plasma (PRP) | Active comparator | single injection of platelet-rich plasma Receives: Biological: injection of Platelet-rich Plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
Measured: Time Frame: 24 months evaluation
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
change in IKDC and KOOS score
Measured: Time Frame: 6 months evaluation
Secondary outcomes (2)
stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
Change in IKDC Subjective score from baseline to follow up
Measured: Time Frame: 6, 24 months evaluation
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS score from baseline to follow up
Measured: Time Frame: 3,6, 12, 24 months evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start24 Feb 2017
- Primary completion24 Aug 2022 (estimated)
- Study completion24 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lipogems International spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prof. Marcacci, Lipogems International spa
- Investigators
- Silvia Versari, Study director, Lipogems International spa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117608
- Sponsor's protocol ID
- LIPOJOINT
- Acronym
- LIPOJOINT
- Status last verified
- Aug 2017
- First submitted
- 6 Apr 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE
- ClinicalTrials.gov ID
- NCT03117608
- Acronym / sponsor ID
- LIPOJOINT / LIPOJOINT
- Conditions
- Osteoarthritis, Knee
- Keywords
- OA, aMAT, PRP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Lipogems International spaIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 24 Aug 2022 (estimated)
- Study completion
- 24 Feb 2024 (estimated)
- First posted
- 18 Apr 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 study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
Detailed description
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59 patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three, six, twelve, and twenty-four months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) | Experimental | Biological: injection of autologous micro-fragmented adipose tissue (aMAT)injection of aMAT obtained with Lipogems® technology. |
| platelet-rich plasma (PRP) | Active comparator | Biological: injection of Platelet-rich Plasma (PRP)single injection of platelet-rich plasma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients provided written informed consent;
- Patients aged between 18 and 75 years;
- Knee symptomatic OA (Kellgren-Lawrence grade 1-4)
- Failure of conservative treatment for at least 3 months;
- Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
Key exclusion criteria (10 listed)
- Patients incapable to understanding and will;
- Patients participating in previous, concurrent or not, trials (ongoing or completed within three months);
- Patients surgically treated for the same defect within one year;
- Patients affected by malignancy;
- Patients affected by metabolic or thyroid disorders;
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 |
|---|---|---|
| injection of autologous micro-fragmented adipose tissue (aMAT)adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology. | Biological | AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) |
| injection of Platelet-rich Plasma (PRP)injection of platelet-rich plasma | Biological | platelet-rich plasma (PRP) |
Primary outcome
Safety
Time frame: Time Frame: 24 months evaluation
Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
Time frame: Time Frame: 6 months evaluation
change in IKDC and KOOS score
2 secondary outcomes
stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
Time frame: Time Frame: 6, 24 months evaluation
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Time Frame: 3,6, 12, 24 months evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Silvia Versari study director
Lipogems International spa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing injection of autologous micro-fragmented adipose tissue (aMAT) and injection of Platelet-rich Plasma (PRP) in people with Osteoarthritis, Knee, run by Lipogems International spa at 1 site 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 7 inclusion and 10 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 29 Aug 2017. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Versari (+39 02 37072408, silvia.versari@lipogems.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Time Frame: 24 months evaluation). 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 29 Aug 2017.