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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSyntr Health Technologies, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SyntrFuge System

    Device

    Microsized Adipose Tissue

  • Triamcinolone Injection

    Drug

    Corticosteroid

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: SyntrFuge SystemExperimental treatment 1 intervention
Group B: Standard of CareOther 1 intervention

Trial outcomes

Primary outcomes

1

WOMAC

Change of WOMAC Score from Baseline

Time frame
6 months, 12 months, 24 months

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcomes Score (KOOS)

Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time

Time frame
6 months, 12 months, 24 months
2

Single Assessment Numerical Evaluation

Change in Single Assessment Numerical Evaluation (SANE) Over Time

Time frame
6 months, 12 months, 24 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: