Approved Clinical Trials
Recover® Platelet Separation Kit

The following research studies have been approved to determine the safety and effectiveness of concentrated platelets prepared by using the Recover® Platelet Separation Kit in patients with chronic tennis elbow (lateral epicondylitis) and chronic foot pain (plantar fasciitis). Platelet rich plasma (PRP) contains factors that are important in the healing process. Participants will either receive an injection with or without PRP.

Unlike other traditional treatments for elbow and foot pain, the Recover® Kit technique involves a simple injection performed in the office. Only those patients meeting the pre-defined approved inclusion/exclusion criteria are eligible to volunteer in these studies.

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Tennis Elbow

If you suffer from elbow pain for more than three months and would like to volunteer for this tennis elbow trial, please contact the investigators to see if you qualify.

Huntsville, Alabama The Orthopaedic Center 927 Franklin Street Huntsville, AL 35801 www.visittoc.com Joseph W. Clark, M.D. Stanton B.N. Davis, M.D. John J. Greco, M.D. Philip A. Maddox, M.D Study Coordinator: Katie Greer Phone: (256) 539-2728 Indianapolis, Indiana Methodist Sports Medicine Center 201 Pennsylvania Parkway, Suite 325 Indianapolis, IN 46280 Arthur Rettig, M.D. Todd W. Arnold, M.D. Patrick A. Kersey, M.D Lance A. Rettig, M.D Dale S. Snead, M.D Study Coordinator: Patty Hunker, MS Phone: (317) 817-1227

Louisville, Kentucky Louisville Arm and Hand 315 East Broadway, Suite 185 Louisville, KY 40202 Amit Gupta, M.D. Study Coordinator: Kathleen Lyons, RN Phone: (502) 629-4188 Columbus, Ohio OSU Sports Medicine Center 2050 Kenny Road, Suite 3100 Columbus, OH 43221 www.sportsmedicine.osu.edu Grant L. Jones, M.D. James R. Borchers, M.D. Study Coordinator: Angela Pedroza, MS Phone: (614) 293-7952 Washington, DC Georgetown University Hospital 3800 Reservoir Road Washington, DC 20007 Scott G. Edwards, M.D. Study Coordinator: Carolyn Storck, NP Phone: (202) 444-7141

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Foot Pain

If you suffer from foot pain for more than six months and would like to volunteer for this plantar fasciitis trial, please contact the investigators to see if you qualify.

Indianapolis, Indiana Foot and Ankle Services IU School of Medicine 541 Clinical Drive Indianapolis, IN 46202 Dominique A. Nickson, M.D. Study Coordinator: Connie L. Dagon, CCRC Phone: (317) 274-0761

San Diego, California Oasis Medical Center 5471 Kearny Villa Road, Suite 200 San Diego, CA 92123 Kent A. Feldman, DPM Study Coordinator: Sandra Rodgers, RCIS Phone: (619) 206-1506

Investigator/Surgeon Listing: Investigators in this trial require approval by an Institutional Review Board (IRB) to ensure clinical trials are ethical and the rights of the participants are protected.

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Protocol

• You will be randomly assigned to receive an injection with or without PRP.
• Your elbow or foot will be numbed prior to the procedure.

Separation of PRP

• A small amount of your blood is drawn.
• Depending on the study group you have been chosen for, your blood may be placed in a GPS® blood separation tube.
• Your blood is spun in a centrifuge to separate platelets. (Figure 1)
• The PRP is removed into a syringe. (Figure 2)

Injection

• An injection with or without PRP will be administered either into your affected elbow or foot as shown below.

• You will rest for 15 minutes prior to getting up after the injection.

After Procedure Care

• You may apply ice or compression to the injection site as needed (or elevate the affected foot).
• You may take acetaminophen as instructed for pain for no more than the next 48 hours.
• Avoid other pain medications such as asprin, Aleve®, and/or Ibuprophen during that time period.
• Avoid heavy lifting and vigorous activities for the next 4 weeks.

Follow-up

• If you volunteer for these clinical trials, you will be asked to return to your physician to evaluate your elbow or foot for pain, range of motion, and ability to perform daily activities.
• The follow-up visits will be performed at 4, 8 and 12 weeks after your procedure.
• It is extremely important for the success of this study you keep your follow-up appointments.

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