Overview

This trial is active, not recruiting.

Condition articular cartilage defect grade iii or iv of the knee
Treatments autologous cell, standard microfracture arthroscopic surgery
Sponsor Fondren Orthopedic Group L.L.P.
Collaborator InGeneron, Inc.
Start date February 2013
End date August 2016
Trial size 48 participants
Trial identifier NCT01799876, FOG-TOH125

Summary

The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
autologous cell
(Sham Comparator)
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
standard microfracture arthroscopic surgery

Primary Outcomes

Measure
Magnetic Resonance Imaging (MRI) for osteochondral defect filling
time frame: 12 months

Secondary Outcomes

Measure
Pain Scores on Numerical Rating Scale
time frame: up to 1 year
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
time frame: 12 months postop
Knee Range of Motion
time frame: up to 1 year
Number of Patients with Adverse Events as a Measure of Safety
time frame: up to 1 year

Eligibility Criteria

Male or female participants from 18 years up to 68 years old.

Inclusion Criteria: - Subjects undergoing microfracture surgery for the repair of articular cartilage - Osteochondral defect Grade III or IV - Age 18 to 68 years - Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate - Written informed consent - Ability to speak, read and write English or Spanish Exclusion Criteria: - Inability to speak, read and write English or Spanish - Evidence of malignant disorder/neoplasm in past 24 months - History of basal cell carcinoma - History of smoking and not committed to give up - Chronic skin conditions - Connective, metabolic or skin disease - Evidence of active infection - Pregnancy or lactating for female subjects - Diabetes Type I or II - Current steroid use - Immunosuppressive medication - Renal failure (creatine > 1.8 mg/dL) - Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL) - Inflammatory joint diseases of the knee that indicate additional, conflating therapies - Joint infection within the past 6 months - Meniscal resection of greater than 50% prior to, or at time of procedure - Uncorrected joint instability - Joint malalignment > 5 degrees

Additional Information

Official title Autologous Cell Therapy Enhancement of Microfracture Surgery
Principal investigator Robert L Burke, MD
Description Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study. Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients. Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fondren Orthopedic Group L.L.P..