Knee OsteoarthritisNCT04427657
Use of Lipogems for Knee Osteoarthritis
A study testing autologous microfragmented lipoaspirate tissue (Lipogems®). and arthroscopic debridment in people with Knee Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
Trial summary
Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- autologous microfragmented lipoaspirate tissue (Lipogems®). and arthroscopic debridment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesItaly
- Study dates
- 8 Nov 2018to 1 Dec 2020
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,
- age between 45 and 75,
- pain ≥ 6 VAS scale,
- no ligamentous instability,axial deviation less than 10°
- BMI between 18 and 30,
- International Normalized Ratio (INR) < 1.5
Who cannot join
- previous traumatic lesion (tibial fracture, osteothomy) of the knee
- osteonecrosis
- meniscal surgery in the previous 6 weeks
- chemiotherapy, radioteherapy
- diabetes
- alchoolism, psichiatric disease,drug addiction
- coagulation disorders
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Istituto Ortopedico Galeazzi
Milan, 20161
About this study
Official title: Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis
Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement
Read the detailed description
The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous tissue for the treatment of the knee osteoarthritis (OA).
Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at 6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).
The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
Surgical technique: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
- Conditions
- Knee Osteoarthritis
- Being tested
- autologous microfragmented lipoaspirate tissue (Lipogems®)., arthroscopic debridment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous microfragmented lipoaspirate tissue (Lipogems®).Procedure or surgery
patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
arthroscopic debridmentProcedure or surgery
patient in supine position. Under sedation is perform an arthroscopic debridement
| Study group | Role | What they receive |
|---|---|---|
| Controls | Active comparator | 39 patients with knee osteoarthritis undergoing arthroscopic debridement Receives: Procedure: arthroscopic debridment |
| Cases | Experimental | 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). Receives: Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups
Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
Measured: 6 month
Secondary outcomes (3)
Radiological changes at 6 month recorded between the two groups
Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImaging analysis.
Measured: 6 month
Functional changes at 6 month recorded between the two groups
Symptomatic and functional evaluation at 6±1 months by means of Proms that inclued questionnaire about quality of life (SF-12, WOMAC)
Measured: 6 month
Serum changes at 6 month recorded between the two groups
Changes in serum levels of biomarkers related to Osteoarthritis (collagen type II C-telopeptide(CTx-II),collagen type III N-propeptide( PIIINP)) will be evaluated (pre-intervention vs 6±1 months).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Nov 2018
- Primary completion31 Dec 2019
- Study completion1 Dec 2020
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.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- michele ulivi, Principal investigator, IRCCS Istituto Ortopedico GaleazziMilano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427657
- Sponsor's protocol ID
- LipoOA
- Status last verified
- Dec 2020
- First submitted
- 22 Apr 2020
- Last updated
- 6 Jul 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 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Microfragmented Autologous Tissue for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04427657
- Acronym / sponsor ID
- LipoOA
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 11 Jun 2020 (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.
Lipogems system consist in the use of a monouse kit for liposuction, processing and administration of adipose tissue. The use of the final product (microfragmented adipose tissue,not expanded) shoud promote the natural joint homeostasis, associated with a clinical improvement
Detailed description
The Objectiveof the study is to analyse the therapeutic role of microfragmented autologous tissue for the treatment of the knee osteoarthritis (OA).
Main purpose: Symptomatic and functional evaluation at 6 months by comparison of the Knee Injury and Osteoarthritis Outcome Score(KOOS) recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
Secondary Purposes: Evaluation of possible radiological changes pre-operative and after 6±1 months by means of MagneticResonanceImage analysis. Symptomatic and functional evaluation at 6±1 months by means of VisualAnalogueScale, KneeSocietyScore, Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Reduction of anti-inflammatory drugs (pre-intervention versus 6±1 months). Evaluation "quality-adjusted life years" (QUALY) in relation to the questionnaire SatisfactioForm-12 (pre-intervention vs 6±1 months). Check for any adverse effects directly related to the use of micro-fragmented adipose tissue. Changes in serum levels of biomarkers related to OA (CollagenType II C-Telopeptide (CTX-II), collagen type III N-propeptide (PIIINP)) will be evaluated (pre-intervention vs 6±1 months).
The study is an interventional, prospective, randomized, controlled trial. Controls: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement. Cases: n = 39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
Surgical technique: patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | Active comparator | Procedure: arthroscopic debridment39 patients with knee osteoarthritis undergoing arthroscopic debridement |
| Cases | Experimental | Procedure: autologous microfragmented lipoaspirate tissue (Lipogems®).39 patients with knee osteoarthritis undergoing arthroscopic debridement surgery + intrarticular injection of autologous microfragmented lipoaspirate tissue (Lipogems®). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with knee osteoarthritis grade III e IV Kellgren-Lawrence,
- age between 45 and 75,
- pain ≥ 6 VAS scale,
- no ligamentous instability,axial deviation less than 10°
- BMI between 18 and 30,
Key exclusion criteria (8 listed)
- previous traumatic lesion (tibial fracture, osteothomy) of the knee
- osteonecrosis
- meniscal surgery in the previous 6 weeks
- chemiotherapy, radioteherapy
- diabetes
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 |
|---|---|---|
| autologous microfragmented lipoaspirate tissue (Lipogems®).patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement. | Procedure or surgery | Cases |
| arthroscopic debridmentpatient in supine position. Under sedation is perform an arthroscopic debridement | Procedure or surgery | Controls |
Primary outcome
Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups
Time frame: 6 month
Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between two groups (6±1 months) undergoing arthroscopic debridement ± injection of autologous microfragmented lipoaspirate tissue (Lipogems®).
3 secondary outcomes
Radiological changes at 6 month recorded between the two groups
Time frame: 6 month
Functional changes at 6 month recorded between the two groups
Time frame: 6 month
Serum changes at 6 month recorded between the two groups
Time frame: 6 month
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 6 Jul 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.
michele ulivi principal investigator
IRCCS Istituto Ortopedico GaleazziMilano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous microfragmented lipoaspirate tissue (Lipogems®). and arthroscopic debridment in people with Knee Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 6 inclusion and 8 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 6 Jul 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.
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?
Symptomatic and functional evaluation at 6 months by comparison of the KOOS score recorded between the two groups (time frame: 6 month). 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 6 Jul 2021.