Parker Waichman LLP

Study Finds No Evidence of Effectiveness and Safety of Newer Joint Replacement Devices

In light of the failure of articular surface replacement and large head size metal-on-metal joint replacement devices, scientists, doctors, and health policy professionals have highlighted the need for a more thorough and evidence-based introduction of joint replacement devices and for the development of an infrastructure for timely evaluation of these devices. In a recently published […]

Joint-Replacement-DevicesIn light of the failure of articular surface replacement and large head size metal-on-metal joint replacement devices, scientists, doctors, and health policy professionals have highlighted the need for a more thorough and evidence-based introduction of joint replacement devices and for the development of an infrastructure for timely evaluation of these devices.

In a recently published study in the BMJ, a group of researchers, led by Dr. Marc J. Nieuwenhuijse, systematically evaluated the evidence concerning the introduction of five innovative, relatively recent, and already widely implemented devices used in total joint replacement. The research team evaluated comparative data from clinical trials, observational studies, and large national arthroplasty registries to study effectiveness and safety of the new devices versus existing, well proven, comparable devices. The five technologies reviewed are ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock (not metal-on-metal) acetabular cups in total hip replacement, and high flexion implants and gender-specific implants in total knee replacement.

After assessing 10,557 search hits, 118 studies (94 unique study cohorts) met the criteria for inclusion. The data related to 15,384 implants in 13,164 patients. None of the five device innovations was found to improve functional or patient reported outcomes, according to the article’s abstract. National registries reported two- to 12-year follow-up for revision occurrence related to more than 200,000 implants. Reported comparative data with well established alternative devices (over 1,200,000 implants) did not show improved device survival. Moreover, the researchers found higher revision occurrence associated with modular femoral necks (hazard ratio 1.9) and ceramic-on-ceramic bearings (hazard ratio 1.0-1.6) in hip replacement and with high flexion knee implants (hazard ratio 1.0-1.8), according to the BMJ.

The researchers wrote that theydid not find convincing high quality evidence supporting the use of five newer devices. Moreover, the data showed that existing devices may be safer to use in total hip or knee replacement. The authors call for improved regulation and professional society oversight “to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety,” according to the BMJ.

 

 

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
ivan makoviychuk
4 years ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness , Value The staff was compassionate and on point! Love my experience with them!
Millette Dukes
2 years ago
5 Star Reviews 150
I would like to thank Kathy and Alex for all their hard work and dedication through out the entire process. I am very happy with the outcome of the case. I would highly recommend to my family and friends.
Alanah Rotunno
7 months ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038