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Efficacy of Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis.

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ClinicalTrials.gov Identifier: NCT03379168
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dustin L. Richter, MD, University of New Mexico

Brief Summary:

Knee osteoarthritis (OA) causes patients considerable joint pain and leads to instability, reduced range of motion, and functional limitations. Current treatment limitations have generated interest in alternative options to restore function and alleviate joint pain, some with the aim of healing damaged articular cartilage. There has been preliminary support in the literature for reduced pain and improved functional performance in patients who receive mesenchymal stem cells (MSCs) as part of a treatment regimen. MSCs can be costly and are limited by complex regulatory issues. This interest in an alternative isolation method lead to the development of Lipogems. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems. In addition, given the limitations of prior research on the efficacy of intra-articular corticosteroids, the investigators will also include this as an additional study group to compare to placebo. There have been case reports published showing favorable outcomes. This would be the first study reporting data on the efficacy of Lipogems for pain relief in knee OA in a randomized, controlled clinical trial with a larger sample of patients.

The investigators hypothesize that patients who receive an injection of Lipogems will experience a decrease in pain of the affected knee and an increase in joint functionality in comparison to placebo. The investigators also hypothesize that patients who receive an intra-articular corticosteroid will experience decreased pain or improved functionality in the affected joint compared to placebo.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Microfragmented Adipose Tissue (Lipogems) Drug: Corticosteroid injection Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be conducted as a randomized, placebo-controlled clinical trial. Patients will be randomized to receive either Lipogems, intra-articular corticosteroids, or a placebo injection of saline. Lipogems is cleared for use by the FDA in orthopaedics and arthroscopy and is offered as a treatment option for knee osteoarthritis. This study will be evaluating the effectiveness (not safety) of Lipogems when compared to corticosteroids and placebo. Thus, no information will be submitted to the FDA.
Masking: Single (Participant)
Masking Description: It is not feasible to blind patients who are randomized to receive Lipogems, as adipose tissue must be obtained from the participant. However, patients randomized to receive intra-articular corticosteroids or placebo injections will be blinded.
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of Micro-fragmented Adipose Tissue and Intra-articular Corticosteroid Injections for Symptomatic Knee Osteoarthritis: a Randomized, Placebo Controlled Study.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Injection
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Drug: Saline
Sterile saline injection will act as a placebo group.

Active Comparator: Corticosteroid Injection
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Drug: Corticosteroid injection
Cortisone is a standard of care injection to reduce joint inflammation.

Experimental: Lipogems Injection
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Device: Microfragmented Adipose Tissue (Lipogems)
Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.




Primary Outcome Measures :
  1. Change in Visual Analog Pain Scale (VAS) Over Time [ Time Frame: Prior to procedure then post-procedure: 2 weeks, 6 weeks, 3 months, 6 months, 1 year. ]
    Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).


Secondary Outcome Measures :
  1. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Over Time [ Time Frame: Prior to procedure then post-procedure: 2 weeks, 6 weeks, 3 months, 6 months, 1 year. ]
    Patient self-reported outcome measure to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The following descriptors are used for all items: none, mild, moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The score can range from 0 to 96; however, this score is typically reported as a percentage of 100 for normalization.

  2. Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time [ Time Frame: Prior to procedure then post-procedure: 2 weeks, 6 weeks, 3 months, 6 months, 1 year. ]
    Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of eighteen or older
  • Diagnosis of symptomatic knee osteoarthritis
  • Radiographic evidence of knee osteoarthritis. Note: For the purposes of this study, radiographic evidence of knee osteoarthritis is defined as any one or more of the following: osteophytes, joint space narrowing, loss of articular cartilage thickness, subchondral sclerosis or cysts.

Exclusion Criteria:

  • History of treatment with any intra-articular knee injection
  • Current ligament instability as demonstrated by a positive Lachman Test, Anterior or Posterior Drawer Test, or positive Valgus or Varus Stress Test.
  • Known allergy to lidocaine
  • Under 18 years of age
  • Pregnant women
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379168


Contacts
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Contact: Dustin Investigator, MD 505-272-1209 DLRichter@salud.unm.edu

Locations
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United States, New Mexico
UNM Hospital Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Principal Investigator         
Sponsors and Collaborators
Dustin L. Richter, MD
Investigators
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Principal Investigator: Dustin Richter, MD UNM Health Sciences Center, Dept of Orthopaedic Surgery

Publications:

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Responsible Party: Dustin L. Richter, MD, Assistant Professor, Department Orthopaedic Surgery, University of New Mexico
ClinicalTrials.gov Identifier: NCT03379168     History of Changes
Other Study ID Numbers: 17-146
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dustin L. Richter, MD, University of New Mexico:
knee osteoarthritis
mesenchymal stem cell
adipose tissue
injection
nonoperative treatment
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases