Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

NCT02025946 | Withdrawn DMC

• 1 other identifier: RECON-EMEA-12
• Study Type: observational
• Target: N/A
• Locations: 7 countries
• Sites: 8

Brief 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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

Total Ankle Arthroplasty

Tibiotalar Arthrodesis

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (8)

Katholieke Universiteit Leuven

Leuven, Belgium

Location

AZ Turnout - Clinic Sint-Jozef

Turnhout, Belgium

Location

Clinique Axium

Aix-en-Provence, France

Location

I.R.C.C.S. Istituto Ortopedico Galeazzi

Milan, Italy

Location

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

Hospital Pedro Hispano

Matosinhos Municipality, Portugal

Location

Hospital clinico y provincial

Barcelona, Spain

Location

Musgrave Park Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jeroen De Wachter

  AZ Turnhout

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2026
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

ES (1); BE (2); GB (1); PT (1); FR (1); IT (1); NL (1)