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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
WOMAC
Secondary outcome measures
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
Single Assessment Numerical Evaluation
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
Triamcinolone Injection
2008
N/A
~180
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Who is running the clinical trial?
Syntr Health Technologies, Inc.Lead Sponsor
2 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the eligibility requirements for participation in this trial?
"This clinical trial is open to participants between the ages of 18 and 70, with a knee condition, who wish to partake in this trial. The maximum amount of volunteers accepted into this study is 176 people."
Answered by AI
Are individuals aged 40 and above eligible for this investigation?
"This clinical trial's enrollment criteria stipulates that candidates must be between 18 and 70 years old. There are 38 medical trials targeting individuals under the age of majority, while 657 studies focus on elderly patients over 65."
Answered by AI
Is the study recruiting participants at this time?
"According to data hosted on clinicaltrials.gov, this medical trial is actively recruiting for participants. The study was first posted on October 1st of 2022 and has undergone periodic updates since then, with the most recent one occurring on September 1st of that same year."
Answered by AI
What is the aggregate amount of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial is presently searching for participants, having been first posted on October 1st 2022 and edited most recently on September 1st 2022. The study aims to recruit 176 patients from 2 sites."
Answered by AI
Who else is applying?
What site did they apply to?
Irvine Site 1
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I do not want to land in a wheelchair because of knee osteoarthritis.
PatientReceived 1 prior treatment
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