Adipose-Derived Regenerative Cells in Total Knee Arthroplasty

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.

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