NCT02025946|WithdrawnDMC
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Sponsor study identifier
observational
0
7 countries
8
Study Start
Not reported
Date not reportedPrimary Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis. The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 31, 2013
Actual (reported)January 1, 2014
Actual (reported)January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
proportion of reoperations in the total ankle replacement arm and in the tibiotalar arthrodesis arm
Reoperation will be defined as any secondary surgery related to the operated ankle or adjacent joints (subtalar, talonavicular and calcaneocuboid joints), excluding wound healing problems.
after 5 years of follow-up
Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm
1, 2, 7 and 10 years
proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm
1, 2, 5, 7 and 10 years
The evolution and clinical outcomes
1, 2, 5, 7 and 10 years
the decision criteria for choosing the surgical technique use
inclusion
Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty, receiving CE-marked medical devices and planned to be operated in compliance with their respective Instructions for Use
Katholieke Universiteit Leuven
Leuven, Belgium
AZ Turnout - Clinic Sint-Jozef
Turnhout, Belgium
Clinique Axium
Aix-en-Provence, France
I.R.C.C.S. Istituto Ortopedico Galeazzi
Milan, Italy
Sint Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
Hospital Pedro Hispano
Matosinhos Municipality, Portugal
Hospital clinico y provincial
Barcelona, Spain
Jeroen De Wachter
AZ Turnhout
0 participants (actual enrollment reported by the registry).
First Submitted
December 31, 2013
First Posted
January 1, 2014
Primary Completion
January 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
Contact the study team to confirm eligibility.
Musgrave Park Hospital
Belfast, United Kingdom
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 13, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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