Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

NCT05526898 | Recruiting FDA Device

• 1 other identifier: SHT-SYN-03
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Microsized Fat Tissue; Adipose Tissue; Fat Transfer; Knee Osteoarthritis; Orthopedic Surgery

Outcome Measures

Primary Outcomes (1)

• WOMAC

  Change of WOMAC Score from Baseline

  6 months, 12 months, 24 months

Secondary Outcomes (2)

• Knee Injury and Osteoarthritis Outcomes Score (KOOS)

  6 months, 12 months, 24 months

• Single Assessment Numerical Evaluation

  6 months, 12 months, 24 months

Study Arms (2)

SyntrFuge System

EXPERIMENTAL

Adipose tissue microsized via the SyntrFuge System

Device: SyntrFuge System

Standard of Care

OTHER

Steroid Injection

Drug: Triamcinolone Injection

Interventions

SyntrFuge System DEVICE

Microsized Adipose Tissue

SyntrFuge System

Triamcinolone Injection DRUG

Corticosteroid

Standard of Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Syntr Health Technologies, Inc.: lead

Study Sites (2)

Irvine Site 1

Irvine, California, 92618, United States

RECRUITING

Irvine Site 2

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Ahmed Zobi, EMBA

CONTACT

949-992-5728; info@syntrhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)