NCT01641848

INBONE™ Total Ankle Prosthesis With Long Talar Stem

Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stryker Trauma and Extremities · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Arthritis
• Infection of Total Ankle Joint Prosthesis

Interventions

Type	Name	Description
DEVICE	INBONE™ Total Ankle Prosthesis with Long Talar Stem	INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-17
• Last updated: 2014-05-22

Locations

1 site across 1 country: United States