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SyntrFuge™-Processed Adipose Tissue for Knee Osteoarthritis
N/A
Recruiting
Research Sponsored by Syntr Health Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months, 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to process fat for knee surgery patients with osteoarthritis. The new method will be compared to the current standard of care.
Who is the study for?
This trial is for adults aged 35-80 with moderate to severe knee osteoarthritis. Participants must be in good health, not pregnant or nursing, and have a BMI between 20 and 34.9. They should be able to walk and commit to the study schedule. Exclusions include uncontrolled diseases, recent immunosuppressive therapy, coagulation disorders, current drug/alcohol abuse, recent other treatments for osteoarthritis or participation in another study.
What is being tested?
The trial tests the SyntrFuge™ System's effectiveness on knee osteoarthritis by comparing adipose tissue processed with this system followed by an injection of microsized adipose tissue against standard care practices.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, risk of infection due to injections, allergic reactions to materials used during treatment (though specifics are not provided), and general discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months, 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
WOMAC
Secondary study objectives
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Single Assessment Numerical Evaluation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SyntrFuge SystemExperimental Treatment1 Intervention
Adipose tissue microsized via the SyntrFuge System
Group II: Standard of CareExperimental Treatment1 Intervention
Steroid Injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SyntrFuge System
2021
N/A
~20
Triamcinolone Injection
2008
N/A
~180
Find a Location
Who is running the clinical trial?
Syntr Health Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
66 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with osteonecrosis.I am unable to make my own medical decisions.I have had a previous knee injury or surgery.I am not pregnant or breastfeeding.I haven't had a corticosteroid injection into a joint in the last 6 months.I had meniscal surgery within the last 6 weeks.I have gout or high cholesterol.I do not have any uncontrolled illnesses.My knee arthritis is moderate to severe.I have inflammatory arthritis.I haven't had any cell therapy injections in my joints in the last 6 months.I can walk on my own.I haven't had immunosuppressive therapy or steroids in the last 3 months.I have a blood clotting disorder.I haven't taken any treatments that could affect the trial's safety or results.I haven't taken blood thinners or anti-inflammatory drugs like aspirin or ibuprofen in the last 7 days.I am willing and able to follow the study's requirements and attend all follow-up visits.I am between 35 and 80 years old.I have had knee pain for at least 3 months.I currently have an active infection.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: SyntrFuge System
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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