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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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.

  1. Visual Analogue Scale for pain (VAS)

    Measured: 3-, 6-,12-, 24- and 48 months follow-up.

Secondary outcomes (3)
  1. Tegner score

    Measured: 3-, 6-,12-, 24- and 48 months follow-up.

  2. Knee Injury & Osteoarthritis Outcome (KOOS) score

    Measured: 3-, 6-,12-, 24- and 48 months follow-up.

  3. 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.

  1. First posted9 Aug 2024
  2. Study startJan 2016
  3. Primary completionJan 2020
  4. Study completionJan 2024

Resources

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)
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

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.

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