Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments autologous cells and total knee arthroplasty, standard total knee arthroplasty surgery
Sponsor Fondren Orthopedic Group L.L.P.
Collaborator InGeneron, Inc.
Start date September 2014
End date December 2016
Trial size 60 participants
Trial identifier NCT02262988, FOG-TOH150

Summary

The purpose of this study is to assess the potential benefit of enhancing total knee arthroplasty (TKA) surgery using some of your own cells taken from fat tissue that may be able to help recovery and repair of knee tissues.

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 recovered from the patient's infrapatellar fat pad will be processed using the Transpose RTTM system (InGeneron, Inc., Houston, TX, USA). The processed cells are injected into the knee as adjuvant treatment for total knee arthroplasty (TKA).
autologous cells and total knee arthroplasty Transpose RTTM system (InGeneron, Inc.)
(Placebo Comparator)
Standard total knee arthroplasty (no fat cells harvested).
standard total knee arthroplasty surgery

Primary Outcomes

Measure
Knee Injury and Osteoarthritis Outcomes Survey (KOOS)
time frame: up to 3 months

Secondary Outcomes

Measure
Pain Scores on Numerical Rating Scale
time frame: up to 3 months
Knee swelling
time frame: up to 3 months
Knee Range of Motion
time frame: up to 3 months
Number of Patients with Adverse Events as a Measure of Safety
time frame: up to 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Subjects undergoing total knee arthroplasty for osteoarthritis - Age 18 to 80 years - Existing infrapatellar fat pad in surgical knee - 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 60 months - Contraindication for removal of infrapatellar fat pad - 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 - Current corticosteroid use - Immunosuppressive medication - Renal failure (creatine > 1.8 mg/dL) - Hepatic failure (AST, ALT > 2x normal values; bilirubin > 2 mg/dL) - Inflammatory joint diseases of the knee that indicate additional, conflating therapies - Joint infection within the past 6 months - No prisoners or mentally disabled persons - No Workers' Compensation cases

Additional Information

Official title Intra-articular Injection of Autologous Adipose-Derived Regenerative Cells (ADRCs) as Adjuvant Therapy for Total Knee Arthroplasty
Principal investigator Robert L Burke, MD
Description Your participation in this study will require that you allow the surgical team to use a fat pad in your knee that is usually discarded during surgery to harvest regenerative cells. The fat pad will be processed using the Transpose RTTM system (InGeneron, Inc., Houston, TX, USA) to produce adipose-derived regenerative cells. These cells will be re-injected in your knee during the surgery. 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. All patients will have the infrapatellar fat pad removed as part of the normal total knee arthroplasty surgery. Some patients will have the fat pad processed and cells inserted back in their knee. Other patients will have saline inserted into the knee in the same manner as the fat pad cells. To which group of patients/participants you would be assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients. Your participation will require that you attend your regularly scheduled postoperative visits. You will not have to make any extra clinic visits for this study. After you leave the hospital, you will be asked to rate your pain daily until you return for your first postoperative visit at 7-10 days. At your postoperative visits at 7-10 days, 1 month and 3 months, you will be asked to fill out a short questionnaire and your knee swelling, range of motion and function will be evaluated by Dr. Burke. Your participation in this study would also allow the investigator (Dr. Burke) to use certain information from your medical records, although your name or identity will not be revealed publicly in any resulting report or summary of the study.
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..