Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02262988


Primary Contact:

Principal Investigator
Robert L Burke, MD
Fondren Orthopedic Group L.L.P.


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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