Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Arthritis Clinical Trial

Official title:

Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02025946
• Other study ID #: RECON-EMEA-12
• Status: Withdrawn
• Phase: N/A
• First received: December 31, 2013
• Last updated: August 11, 2015
• Est. completion date: January 2026

Study information

• Verified date: August 2015
• Source: Integra LifeSciences Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeFrance: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertésItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Portugal: Ethics Committee for Clinical ResearchSpain: Comité Ético de Investigación ClínicaUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2026
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient with isolated symptomatic end-stage ankle arthritis who needs a tibiotalar arthrodesis or a mobile-bearing total ankle arthroplasty

• Patient receiving CE marked medical devices and planned to be operated in compliance with their respective Instructions for Use

• Patient aged between 40 and 75 years old

Exclusion Criteria:

• Patient who already had before his inclusion in this study a tibiotalar arthrodesis or a total ankle arthroplasty in the same ankle

• Patient with planned or existing arthrodesis of adjacent joints (subtalar, talonavicular and calcaneaocuboid joint)

• Patient with ankle deformity > 20° (weight bearing X-rays)

• Patient with history of infection of the ankle joint (positive culture) or current infection of the ankle joint (positive culture)

• Patient with neuropathy or with a history of diabetes mellitus for more than 15 years

• Patient with avascular necrosis of the talus >25%

• Patient already included in the study for the other ankle

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven	Leuven
Belgium	AZ Turnout - Clinic Sint-Jozef	Turnhout
France	Clinique Axium	Aix en Provence
Italy	I.R.C.C.S. Istituto Ortopedico Galeazzi	Milan
Netherlands	Sint Lucas Andreas Ziekenhuis	Amsterdam
Portugal	Hospital Pedro Hispano	Matosinhos
Spain	Hospital clinico y provincial	Barcelona
United Kingdom	Musgrave Park Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Belgium,  France,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Proportion of reoperation in the tibiotalar arthrodesis arm and in the total ankle replacement arm	The proportion of reoperation as defined above and for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm	1, 2, 7 and 10 years	Yes
Secondary	proportion of revision for the whole study period in the tibiotalar arthrodesis arm and in the total ankle replacement arm	For the arthrodesis arm, a revision will be defined as a reoperation for one of the following reasons: nonunion or pseudoarthrosis or malunion. Hardware removal will not be considered as a revision.; For the total ankle arthroplasty arm, a revision will be defined as the change of any metallic component of the implanted device. The incidental change of the polyethylene will not be considered as a revision except when it is broken without any	1, 2, 5, 7 and 10 years	Yes
Secondary	The evolution and clinical outcomes	Pain measured using a Visual Analog Scale (VAS); Ankle function measured using the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale; Level of activity measured using the University of California, Los Angeles (UCLA) activity scale; Quality of life measured using the EQ5D™ questionnaire; Arthritis status of adjacent joints measured using the Kellgren-Lawrence grading scale; Patient satisfaction	1, 2, 5, 7 and 10 years	No
Secondary	the decision criteria for choosing the surgical technique use	Reason for choosing the Total ANkle Arthroplasty or Tibiotalar Arthrodesis	inclusion	No