Intra-articular Adipose Tissue Injections for Osteoarthritis

NCT03242707 | Unknown

• 1 other identifier: HS-17-00365
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)

  WOMAC-A is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain.

  Change from baseline WOMAC score at 6 months

Secondary Outcomes (3)

• Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)

  Change from baseline in PROMIS-29 from baseline to 6 months

• Western Ontario and McMaster Universities Osteoarthritis Index

  Change from baseline in PROMIS-29 from baseline to 6 months

• Clinical Anchors

  Clinical anchors from baseline to 6 months

Other Outcomes (4)

• Synovial fluid analysis

  Baseline, 6 weeks and 6 months

• Short-term clinical evaluation - WOMAC

  Change from baseline at 6 weeks

• Short-term clinical evaluation - PROMIS

  Change from baseline at 6 weeks

Study Arms (2)

Autologous adipose tissue knee injection

EXPERIMENTAL

Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint.

Biological: Autologous adipose tissue injection

Hyaluronic Acid knee injection

ACTIVE COMPARATOR

Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment.

Drug: Hyaluronic Acid

Interventions

Autologous adipose tissue injection BIOLOGICAL

20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue. The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.

Also known as: Lipogems, Microfragmented fat

Autologous adipose tissue knee injection

Hyaluronic Acid DRUG

Synvisc-One® is a high molecular weight sodium hyaluronate.

Hyaluronic Acid knee injection

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45 to 75, inclusive
• Normal axial alignment
• X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
• WOMAC-pain: Between 9 and 19, inclusive
• Willingness to participate all scheduled follow-ups
• Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
• BMI \< 40

You may not qualify if:

• Pregnant or lactating
• Intra-articular injection within 3 months of treatment
• Inflammatory arthritis
• Any disease or active drug use that significantly compromises coagulation
• Significant damage and/or tears of the ACL or other supporting tissues
• Prior knee surgery in the last 6 months in the knee that will be injected
• Active tobacco use
• Active alcohol or substance abuse within 6 months of study entry
• Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
• Knee joint infections, skin diseases or infections in the area of the injection site
• Diabetes
• Active inhaler use
• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (1)

• Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.

  PMID: 30355323 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• C.Thomas Vangsness, MD

  Keck School of Medicine of USC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Fang

CONTACT

323-442-6959; williahf@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients will know which group they have been assigned to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Model Details: Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 8, 2017
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

US (1)