Clinical Trials
Recover® Platelet Separation Kit

Approved Clinical Trial

The following research study has 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). 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, 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 this study.

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.

Philadelphia, PA

Rothman Institute
925 Chestnut Street
Philadelphia, PA 19107

Matthew Ramsey, M.D.
Barbara Frieman, M.D.
Charlie Getz, M.D.
Marc Harwood, M.D.
Bruce Hopper, M.D.
Charles Krome, D.O.
Christopher Mehallo, D.O.
Craig Rubenstein, M.D.
Peter Vitanzo, M.D.

Study Coordinator: Benjamin Zmistowski
Phone: (267) 339-7865

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: Patti Hunker, MS
Phone: (317) 817-1227

Odessa, Texas

Basin Orthopedic Surgical Specialists
1340 East 7th St.
Odessa, TX 79761

Richard Duke, M.D.

Study Coordinator: Deborah Mossbarger, RN, CCRP
Phone: (432) 332-2663

Vail, Colorado

Steadman-Hawkins Clinic
181 W. Meadows Drive, Suite 400
Vail, CO 81658
www.steadmanhawkins.com

David C. Karli, M.D.

Study Coordinator: Brent Robinson
Phone: (970) 479-5785

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
Center For Hand And Elbow Specialists
3800 Reservoir Road
Washington, DC 20007

Scott G. Edwards, M.D.

Study Coordinator: Hand Resident
Phone: (202) 444-0335

Los Angeles, California

The Orthohealing Center
10780 Santa Monica Blvd., Suite 440
Los Angeles, CA
www.orthohealing.com

Steven Sampson, D.O.
Danielle Aufiero, MD

Study Coordinator: Maria DeLeon
Phone: 310-543-5404

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.

Protocol

You will be randomly assigned to receive an injection with or without PRP.
Your elbow 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® Mini blood separation tube.
Your blood is spun in a centrifuge to separate platelets. (Figure 1)
The PRP is removed into a syringe. (Figure 2)

Figure 1

Figure 2

Injection

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

Elbow

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.
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 this clinical trial, you will be asked to return to your physician to evaluate your elbow for pain, range of motion, and ability to perform daily activities.
The follow-up visits will be performed at 4, 8, 12 and 24 weeks after your procedure.
It is extremely important for the success of this study you keep your follow-up appointments.

www.recoverkit.org

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As the manufacturer of biologic products, Biomet Biologics, does not practice medicine and cannot advise patients on medical care. This web site is intended for general product information only, and Biomet Biologics, should not be contacted for medical advice or questions regarding diagnosis or treatment. All medical treatment questions should be directed to a licensed physician.

Clinical Trials Recover® Platelet Separation Kit