Knee OsteoarthritisGemsforKneeNCT06545266
Arthroscopic Debridement Followed by Intra-articular Injection of Micro-fragmented Adipose Tissue in Patients Affected by Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Istituto Clinico Humanitas.
Trial summary
Background/Objectives: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by small sample size and short follow-up periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- micro-fragmented adipose tissue injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients aged > 18 years, affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).
Who may be able to join
- age > 18 years, patients affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).
Who cannot join
- recent traumatic events involving the index joint, chondromatosis, intra-articular injections of any type in the previous 6 months, malignancy, pregnancy, patients on anticoagulant therapy or suffering from coagulopathies and related disorders, systematic disorders affecting the joints (i.e rheumatoid arthritis). Enrolled patients underwent a knee radiograph (antero-posterior, Rosenberg and lateral projections) as well as MRI before the procedure to stage knee OA and evaluate potential intra-articular loose bodies or diseases different from knee OA (e.g tumors or focal cartilage lesions).
About this study
Background/Objectives: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by small sample size and short follow-up periods. Our aim was to evaluate safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro- fragmented adipose tissue in patients affected by knee OA. Methods: From 2016 to 2020 patients affected by knee OA were enrolled. Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement. VAS for pain, Tegner score, Lysholm score, KOOS score subscales variations were assessed from baseline to 3-, 6-, 12-, 24- and 48 months follow-up.
Read the detailed description
Patients were placed in a supine position and Betadine was used to treat the abdomen.
Anesthesia was performed using disposable blunted cannulas with a modified Klein solution (a mixture of 250 ml of saline solution (4°C), 50 ml of lidocaine (2%) and 1 ml of epinephrine, 1:1000). Two skin incision of approximately 0.5 cm were performed on both sides of the abdomen and the solution was injected in the subcutaneous fat tissue.
Following anesthesia, physicians had to wait at least 15 min before proceeding. Tissue harvesting was performed connecting VacLock vacuum syringe to an aspiration blunt cannula. Approximately the same quantity of tissue was harvested from each side of the patient's abdomen, with a minimum of 100 ml. All procedures were performed by at least two physicians, while the first physician prepared and used the Lipogems ortho kit, the other performed a debridement arthroscopic procedure on the selected knee.
Once the aspiration process was completed, approximately 100 ml of lipoaspirate were processed at each time in the standard 225-ml device. The Lipogems ortho kit is made by a core, a simple disposable device that progressively reduces in size the clusters of adipose tissue (from 1-3.5 mm to clusters of approximately 0.2-0.8 mm) while at the same time eliminating oil and blood residues. The whole procedure takes place in a full immersion system to minimize traumatic actions on cell products. Before starting the procedure, to avoid any cell damage the total absence of air and bubbles in the device was ensured and the core was pre-filled with saline solution from a 1000 ml bag hanging above. It was ensured that the fat that was aspirated was constantly surrounded by a liquid environment, essential to eventually obtain small healthy fat clusters, discarding oil and fat debris. The aspirated fat was pushed from the syringe into the device and through the first reduction filter allowing the corresponding amount of saline to exit from the opposite side reaching the waste bag. Upon each first injection of aspirated fat into this closed system, the floating tissue composed of the lipoaspirate occupied no more than the first half of the core device while keeping it in a vertical position. Once this was observed, the device was shaken and the five stainless steel marbles present inside the system allowed to emulsify oil residues, subsequently removed by gravity along with blood components and the saline solution counterflow. On the other hand, the adipocyte clusters remained or migrated to the top of the device. Once the solution in the device appeared clear and the lipoaspirate yellow, the saline flow was interrupted, and the device rotated by 180°. At this point the process continued by passing the adipose cluster that was obtained through a second size reduction filter and pushing additional fluid from the lower opening of the device. This allowed to obtain a second adipose cluster reduction. At this point the final Lipogems product was ready to be collected in 10 ml syringes from the upper opening and ready for its knee intra-articular injection at the level of the superolateral edge of the patella. This process required approximately 20 min and the final product volume obtained was roughly 25%-30% of the initial tissue that was harvested. Skin portals were sutured and elastic body belt applied and to be maintained for 10 days. Patients were usually discharged the same day of the procedure with a postoperative pain managements protocol (Paracetamol 1000 mg 1 tablet three times a day for 5 days and Ibuprofen 600 mg 1 tablet twice a day for 2 days) and a thromboembolic prophylaxis protocol (low molecular weight heparin for 1 week). Crutches were suggested for the first two days and full weightbearing allowed from the first postoperative day.
- Conditions
- Knee Osteoarthritis
- Being tested
- micro-fragmented adipose tissue injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-fragmented adipose tissue injectionProcedure or surgery
Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for pain (VAS)
Measured: 3-, 6-,12-, 24- and 48 months follow-up.
Secondary outcomes (3)
Tegner score
Measured: 3-, 6-,12-, 24- and 48 months follow-up.
Knee Injury & Osteoarthritis Outcome (KOOS) score
Measured: 3-, 6-,12-, 24- and 48 months follow-up.
Failure rate
Measured: 3-, 6-,12-, 24- and 48 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study startJan 2016
- Primary completionJan 2020
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545266
- Sponsor's protocol ID
- 2219
- Acronym
- GemsforKnee
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruno AAM, Anzillotti G, De Donato M, Basso M, Tamini J, Dupplicato P, Kon E, Di Matteo B, Arnaldi E. Arthroscopic debridement followed by intra-articular injection of micro-fragmented adipose tissue in patients affected by knee osteoarthritis: Clinical results up to 48 months from a prospective clinical study. J Exp Orthop. 2025 Jan 17;12(1):e70144. doi: 10.1002/jeo2.70144. eCollection 2025 Jan.
PubMed 39830171
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Debridement Followed by Intra-articular Injection of Micro-fragmented Adipose Tissue in Patients Affected by Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06545266
- Acronym / sponsor ID
- GemsforKnee / 2219
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 9 Aug 2024 (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.
Background/Objectives: Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by small sample size and short follow-up periods. Our aim was to evaluate safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro- fragmented adipose tissue in patients affected by knee OA. Methods: From 2016 to 2020 patients affected by knee OA were enrolled. Micro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement. VAS for pain, Tegner score, Lysholm score, KOOS score subscales variations were assessed from baseline to 3-, 6-, 12-, 24- and 48 months follow-up.
Detailed description
Patients were placed in a supine position and Betadine was used to treat the abdomen.
Anesthesia was performed using disposable blunted cannulas with a modified Klein solution (a mixture of 250 ml of saline solution (4°C), 50 ml of lidocaine (2%) and 1 ml of epinephrine, 1:1000). Two skin incision of approximately 0.5 cm were performed on both sides of the abdomen and the solution was injected in the subcutaneous fat tissue.
Following anesthesia, physicians had to wait at least 15 min before proceeding. Tissue harvesting was performed connecting VacLock vacuum syringe to an aspiration blunt cannula. Approximately the same quantity of tissue was harvested from each side of the patient's abdomen, with a minimum of 100 ml. All procedures were performed by at least two physicians, while the first physician prepared and used the Lipogems ortho kit, the other performed a debridement arthroscopic procedure on the selected knee.
Once the aspiration process was completed, approximately 100 ml of lipoaspirate were processed at each time in the standard 225-ml device. The Lipogems ortho kit is made by a core, a simple disposable device that progressively reduces in size the clusters of adipose tissue (from 1-3.5 mm to clusters of approximately 0.2-0.8 mm) while at the same time eliminating oil and blood residues. The whole procedure takes place in a full immersion system to minimize traumatic actions on cell products. Before starting the procedure, to avoid any cell damage the total absence of air and bubbles in the device was ensured and the core was pre-filled with saline solution from a 1000 ml bag hanging above. It was ensured that the fat that was aspirated was constantly surrounded by a liquid environment, essential to eventually obtain small healthy fat clusters, discarding oil and fat debris. The aspirated fat was pushed from the syringe into the device and through the first reduction filter allowing the corresponding amount of saline to exit from the opposite side reaching the waste bag. Upon each first injection of aspirated fat into this closed system, the floating tissue composed of the lipoaspirate occupied no more than the first half of the core device while keeping it in a vertical position. Once this was observed, the device was shaken and the five stainless steel marbles present inside the system allowed to emulsify oil residues, subsequently removed by gravity along with blood components and the saline solution counterflow. On the other hand, the adipocyte clusters remained or migrated to the top of the device. Once the solution in the device appeared clear and the lipoaspirate yellow, the saline flow was interrupted, and the device rotated by 180°. At this point the process continued by passing the adipose cluster that was obtained through a second size reduction filter and pushing additional fluid from the lower opening of the device. This allowed to obtain a second adipose cluster reduction. At this point the final Lipogems product was ready to be collected in 10 ml syringes from the upper opening and ready for its knee intra-articular injection at the level of the superolateral edge of the patella. This process required approximately 20 min and the final product volume obtained was roughly 25%-30% of the initial tissue that was harvested. Skin portals were sutured and elastic body belt applied and to be maintained for 10 days. Patients were usually discharged the same day of the procedure with a postoperative pain managements protocol (Paracetamol 1000 mg 1 tablet three times a day for 5 days and Ibuprofen 600 mg 1 tablet twice a day for 2 days) and a thromboembolic prophylaxis protocol (low molecular weight heparin for 1 week). Crutches were suggested for the first two days and full weightbearing allowed from the first postoperative day.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged > 18 years, affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).
Key inclusion criteria (1 listed)
- age > 18 years, patients affected by radiologically confirmed knee OA according to Kellgren-Lawrence classification, not responsive to at least 3 months of conservative treatment (e.g. physical therapy, exercise).
Key exclusion criteria (1 listed)
- recent traumatic events involving the index joint, chondromatosis, intra-articular injections of any type in the previous 6 months, malignancy, pregnancy, patients on anticoagulant therapy or suffering from coagulopathies and related disorders, systematic disorders affecting the joints (i.e rheumatoid arthritis). Enrolled patients underwent a knee radiograph (antero-posterior, Rosenberg and lateral projections) as well as MRI before the procedure to stage knee OA and evaluate potential intra-articular loose bodies or diseases different from knee OA (e.g tumors or focal cartilage lesions).
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 |
|---|---|---|
| micro-fragmented adipose tissue injectionMicro-fragmented adipose tissue was obtained through the Lipogems kit and intraarticularly injected after an arthroscopic debridement. | Procedure or surgery | – |
Primary outcome
Visual Analogue Scale for pain (VAS)
Time frame: 3-, 6-,12-, 24- and 48 months follow-up.
3 secondary outcomes
Tegner score
Time frame: 3-, 6-,12-, 24- and 48 months follow-up.
Knee Injury & Osteoarthritis Outcome (KOOS) score
Time frame: 3-, 6-,12-, 24- and 48 months follow-up.
Failure rate
Time frame: 3-, 6-,12-, 24- and 48 months follow-up.
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 Aug 2024.
- Derived from this study: PubMed 39830171Bruno AAM, Anzillotti G, De Donato M, Basso M, Tamini J, Dupplicato P, Kon E, Di Matteo B, Arnaldi E. Arthroscopic debridement followed by intra-articular injection of micro-fragmented adipose tissue in patients affected by knee osteoarthritis: Clinical results up to 48 months from a prospective clinical study. J Exp Orthop. 2025 Jan 17;12(1):e70144. doi: 10.1002/jeo2.70144. eCollection 2025 Jan.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Istituto Clinico Humanitas.
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 1 inclusion and 1 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 Aug 2024. 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.
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?
Visual Analogue Scale for pain (VAS) (time frame: 3-, 6-,12-, 24- and 48 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545266, which also lists 1 linked publication.
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 Aug 2024.