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Clinical Trial Summary

The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.


Clinical Trial Description

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device,and adverse event data. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years. The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol. The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon: - No revisions for any reason - Oxford Knee Score >38 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03589300
Study type Interventional
Source Zimmer Biomet
Contact
Status Completed
Phase N/A
Start date April 30, 2018
Completion date November 30, 2022

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