Knee OsteoarthritisNCT05526898
Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
A study testing SyntrFuge System and Triamcinolone Injection in people with Knee Osteoarthritis, run by Syntr Health Technologies, Inc. at 2 sites in United States.
Trial summary
This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- SyntrFuge System and Triamcinolone Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2027to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged of 35-80 years old
- Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
- Chronic knee pain or symptoms for at least 3 months
- BMI between 20 and 34.9
- Willing and able to read and sign the informed consent and other study materials
- Written informed consent has been obtained prior to any study-related procedures
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- Written Authorization for Use and Release of Health and Research Study Information has been signed
- Subjects are ambulatory
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
- Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
- Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation
Who cannot join
- Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
- Subjects with osteonecrosis
- Subjects with meniscal surgery in the previous 6 weeks
- Subjects with gout, hyperlipidemia
- Subjects without decisional capacity
- Subjects with inflammatory arthritis
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- Subjects with active infection
- Subjects with any uncontrolled systemic disease
- Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
- Subjects planning to become pregnant, are pregnant, or are breast-feeding
- Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
- Subjects who have active autoimmune disease
- Subjects who have coagulation disorders
- Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations
- Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
- Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
- Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 7 days pre- to 3 days post injection. A wash out period of 7 days is allowed
- Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
- No intra-articular injection of corticosteroids within the last 24 weeks
- No intra-articular injection of any other cellular therapy within the last 24 weeks
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Irvine Site 1
Irvine, California, 92618
Irvine Site 2
Irvine, California, 92618
About this study
Official title: Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
- Conditions
- Knee Osteoarthritis
- Being tested
- SyntrFuge System, Triamcinolone Injection
- Keywords
- Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Knee Osteoarthritis, Orthopedic Surgery
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntrFuge SystemDevice
Microsized Adipose Tissue
Triamcinolone InjectionDrug
Corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| SyntrFuge System | Experimental | Adipose tissue microsized via the SyntrFuge System Receives: Device: SyntrFuge System |
| Standard of Care | Other | Steroid Injection Receives: Drug: Triamcinolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Change of WOMAC Score from Baseline
Measured: 6 months, 12 months, 24 months
Secondary outcomes (2)
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Measured: 6 months, 12 months, 24 months
Single Assessment Numerical Evaluation
Change in Single Assessment Numerical Evaluation (SANE) Over Time
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Dec 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syntr Health Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526898
- Sponsor's protocol ID
- SHT-SYN-03
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized Controlled Trial Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05526898
- Acronym / sponsor ID
- SHT-SYN-03
- Conditions
- Knee Osteoarthritis
- Keywords
- Microsized Fat Tissue, Adipose Tissue, Fat Transfer, Knee Osteoarthritis, Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Syntr Health Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Sep 2022 (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.
This is an multi-center study with the aim of evaluating the efficacy of adipose tissue processed with the SyntrFuge™ system in Orthopedic Surgery, specifically Knee Osteoarthritis. Patients will be enrolled to the treatment group with adipose tissue processed with the SyntrFuge™ system followed by an injection of autologous microsized adipose tissue in the treatment sites or Standard of Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SyntrFuge System | Experimental | Device: SyntrFuge SystemAdipose tissue microsized via the SyntrFuge System |
| Standard of Care | Other | Drug: Triamcinolone InjectionSteroid Injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects aged of 35-80 years old
- Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
- Chronic knee pain or symptoms for at least 3 months
- BMI between 20 and 34.9
- Willing and able to read and sign the informed consent and other study materials
Key exclusion criteria (20 listed)
- Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
- Subjects with osteonecrosis
- Subjects with meniscal surgery in the previous 6 weeks
- Subjects with gout, hyperlipidemia
- Subjects without decisional capacity
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 |
|---|---|---|
| SyntrFuge SystemMicrosized Adipose Tissue | Device | SyntrFuge System |
| Triamcinolone InjectionCorticosteroid | Drug | Standard of Care |
Primary outcome
WOMAC
Time frame: 6 months, 12 months, 24 months
Change of WOMAC Score from Baseline
2 secondary outcomes
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Time frame: 6 months, 12 months, 24 months
Single Assessment Numerical Evaluation
Time frame: 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyntrFuge System and Triamcinolone Injection in people with Knee Osteoarthritis, run by Syntr Health Technologies, Inc. at 2 sites in United States.
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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 20 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Zobi, EMBA (949-992-5728, info@syntrhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 6 months, 12 months, 24 months). 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 20 Aug 2026.