Biomet Hip Resurfacing System Clinical Trial

[Pat Walter]

Biomet Hip Resurfacing System Clinical Trial
April 10, 2012 in Hip Implants

The Biomet Hip Resurfacing System clinical trial has been approved by the FDA to determine if the Biomet total resurfacing system is safe and a viable alternative to total hip replacement surgery. The FDA protocol determines which patients may be eligible to take part in the study. The FDA also requires that doctors participating in this study be approved by the Institutional Review Board (IRB) for the Protection of Human Subjects.

Here is the Info from the Biomet Website:

http://www.biomet.com/patients/clinical_recruitment_recap.cfm

The Biomet® ReCap® Total Hip Resurfacing System clinical trial is approved by Food and Drug Administration (FDA). The purpose of this research study is to determine the safety and effectiveness of this total resurfacing system, a bone sparing alternative to traditional total hip replacement surgery. Only those patients that meet the pre-defined inclusion/exclusion criteria defined in the FDA approved protocol are eligible to be enrolled in the study.

To be considered for this study, please contact the following investigators of this study.

Investigator/Surgeon Listing

* Investigators' participation in this study requires approval by an Institutional Review Board (IRB) for the Protection of Human Subjects. There will be more investigators added to the following list once they receive IRB approvals.

Listed Alphabetically

W. Vincent Burke, MD
300 SE 17th Street
Ft Lauderdale, FL 33316
(954) 764-2192

Stephen R. Burton, M.D.
4466 W. Bristol Road
Flint, MI 48507
Phone (810) 733-1200

David N. Feldman M.D.
(201) 503-0447
Institute for Clinical Research at Holy Name Hospital
718 Teaneck Road
Teaneck, NJ 07666
(201)541-6312

Michael A. Jacobs, M.D.
Chief of Orthopedic Surgery - Good Samaritan Hospital
Assistant Professor of Orthopedic Surgery - Johns Hopkins University
Team Orthopedist - Baltimore Orioles Baseball Team
Specialties - Hip Replacement, Knee Replacement, Shoulder Replacement, Arthroscopy
Good Samaritan Hospital
Russell Morgan Bldg. - Room 405
5601 Loch Raven Blvd.
Baltimore, MD 21239
410-532-4764
410-532-4725 (fax)
Web Site: http://www.goodsam-md.org
Contact: Ms. Kathy Keller-Guglietta

Amir Jamali, M.D.
Assistant Professor of Orthopaedic Surgery - University of California at Davis
UC Davis Health System
Department of Orthopaedics
4860 Y Street, Suite 3800
Sacramento, CA 95817

Contact: Noelle Nord
Clinical Research Coordinator
Office: (916) 734-6291
Fax: (916) 734- 7904
Email: Noelle.Nord@ucdmc.ucdavis.edu

Sidney N. Martin, M.D.
4466 W. Bristol Road
Flint, MI 48507
Phone (810) 733-1200

Brian E. McGrath, M.D.
Associate Professor Orthopaedic Surgery
State University of New York at Buffalo
University Orthpaedics
4949 Harlem Rd.
Amherst, NY 14226

Contact: Mary Bayers-Thering, MS, MBA Study Coordinator
Phone: 716-859-1253
Email: mbayers-thering@kaleidahealth.org

J. Wesley Mesko, MD
2815 S. Pennsylvania Suite 204
Lansing, MI 48910
Phone: 517-267-0200

Mathew J. Phillips, M.D.
Clinical Assistant Professor Orthopaedic Surgery
Full-Time Faculty State University of New York at Buffalo
University Orthpaedics
4949 Harlem Rd.
Amherst, NY 14226

Contact: Mary Bayers-Thering, MS, MBA Study Coordinator
Phone: 716-859-1253
Email: mbayers-thering@kaleidahealth.org

Mitchell B. Sheinkop, M.D.
1725 West Harrison Street
Suite 1063
Chicago, Illinois 60612
www.miniincision.com

Contact: Mary Langhenry, P.T., OCS
Clinical Research Coordinator
Phone: 312-432-2378 Fax: 312-563-0579 Email: mlanghenry@yahoo.com

Edwin P. Su, M.D.
Hospital for Special Surgery
535 East 70th Street
New York, NY 10021
(212)606-1128

Norman E. Walter, M.D.
4466 W. Bristol Road
Flint, MI 48507
Phone (810) 733-1200


Pat

[Pat Walter]

I have already written to Lee Webb to ask why Dr. Gross's name is not on the list.  Maybe because he uses the cementless device.  I will know more when she answers me.

Just thought I would post an answer before everyone asks.

Pat

[einreb]

I have already written to Lee Webb to ask why Dr. Gross's name is not on the list.  Maybe because he uses the cementless device.  I will know more when she answers me.

Just thought I would post an answer before everyone asks.

Pat

Pat,

I'm not sure of the full process, but this has been ongoing for years and Dr Gross is not part of the data sample.  He mentioned that when I went in for surgery last year.  I have a hunch that the 'off label' use data is what was used to move it forward with the FDA into the clinical trial phase. I'm pretty sure this is for the cement-less device, but I'll be interested to hear what Lee has to say on it.

Interesting stuff since there must be a lot of pressure on the FDA regarding MOM.

Thanks,

-Bernie

[Dayton96]

Pat,

Did you ever hear back from Lee about why Dr. Gross is not participating in the study?

Mac

[Tin Soldier]

Yeah I was wondering the same thing.  Gross is one of the biggest, maybe the biggest proponents of the Biomet.  Like Bernie says, I bet it has to do with the cementless femoral component.

[Jbennett]

Does that mean it's free for participants?

[einreb]

Like Bernie says, I bet it has to do with the cementless femoral component.

I *think* the trial is for the cementless.  I *think* that Dr Gross is not in the study group because he was the developing surgeon.

He made it a point to mention that he did have the best stats for it though...

-Bernie

[Pat Walter]

Lee Webb from Dr. Gross's office answered my email with the info below:

"Dr. Gross chose not to participate in the FDA trials because he would be restricted on the number of implants he could use. "

Pat

[imgetinold]

The drawback of his absence is that - I imagine - many of the participating surgeons are not yet proficient with the device, and potentially with resurfacing at all.  So, there may likely be higher initial learning curve problems - and hence higher complication rates.