INBONE™ Total Ankle Prosthesis With Long Talar Stem

Status Terminated

Clinical Trial Summary

The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.

Clinical Trial Description

The FDA approved the "limited enrollment" registry to provide us with additional clinical data from which to design a pivotal IDE study. FDA has stated that their decision for this was based upon "adequate safety information" which was submitted to them as part of the original IDE submission. Therefore, the purpose of this "limited enrollment" registry study is to gather initial data on the device's performance, when used with a Calcaneal Stem. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Arthritis
Infection of Total Ankle Joint Prosthesis

Clinical Trial Details

NCT number	NCT01641848
Study type	Interventional
Source	Wright Medical Technology
Contact
Status	Terminated
Phase	N/A
Start date	December 2010
Completion date	December 2012

View Details

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