Trial | NCT03399630  Report issue

Title

Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee
Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.
This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.
Study Started
Aug 09
2016
Primary Completion
Feb 28
2018
Study Completion
May 31
2018
Last Update
Jun 26
2018

Other Injection of Autologous Adipose Tissue

Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis

Other Injection of lactated ringers

Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.

Injection of Autologous Adipose Tissue Active Comparator

Treatment knee receives injection of 1.5 cc's of adipose tissue mixed with 1.5 cc's of Lactated Ringers

Injection of Lactated Ringers Placebo Comparator

Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue

Criteria 

Inclusion Criteria:

Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
Males and females 40-75 years old.
Participants will be in good health (ASA Class I-II) with a BMI < 35.
Continued pain in the knee despite conservative therapies for at least 6 months.
Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
Must speak, read and understand English.
Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

Participants who have had surgery of either knee within 6 months prior to the screening visit.
Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
Participants that are allergic to lidocaine, epinephrine or valium
History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months
No Results Posted