Clinical Trial: Surgery

Zimmer Knee Study

Full Name

Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA  A prospective, multi-center study to demonstrate safety, performance, and clinical benefits of the Persona Keel CR knee system including instrumentation

Description

Purpose

The purpose of this research is to investigate how participants are doing after being implanted with either the Persona Keel Cemented or Persona Keel Cementless System.  

Description

The study will evaluate the performance, safety, and clinical benefits of two similar knee systems: the Persona Keel Cementless System compared to the Persona Keel Cemented System.  Both of the knee systems are already available on the market and currently being implanted in patients. The devices were developed according to the latest scientific knowledge by leading surgeons together with Zimmer Biomet, the device manufacturer. 

Participation in the study will last a maximum of 5 years.  After surgery, participants  will be asked to attend follow-up visits at 3 months, 1 year, 2 years, and 5 years.

Eligibility

Inclusion Criteria

Inclusion Criteria-including but may not be limited to:

  1.  18 years and older
  2.  Able to complete scheduled follow-up evaluations
  3.  Qualify for either cemented or cementless total knee arthroplasty based upon physical exam and medical history 

To Participate

Please contact the Network Office of Research and Innovation at 610-402-9543.

For additional information

Cemented vs Cementless Persona Keel RCT - Full Text View - ClinicalTrials.gov