Functional and Radiological Outcome after Distal Tibiofibular Arthrodesis for Chronic Instability

Withdrawn

• Conditions: Synostosis / distal tibiofibular arthrodesis; 10023213; 10005944

• Registration Number: NL-OMON35599
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

Adult patients: >18 years
All patients who were treated with a distal tibiofibular arthrodesis (creation of a synostosis) for chronic syndesmotic instability (more than 6 months after initial trauma).

Exclusion Criteria

Patients younger than 18 years at time of follow up.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Functional assessment<br /><br>- AOFAS ankle scores, American Orthopaedic Foot & Ankle Society (AOFAS)<br /><br>ankle-hindfoot clinical rating scale<br /><br>- Foot Ankle Ability Measure (FAAM)<br /><br>- Foot and Ankle Outcome Score (FAOS)<br /><br><br /><br>Radiological assessment<br /><br>- arthritis scores (van Dijk et al./ Kellgren and Moore / etc.)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Perceived disability as quantified by the following scoring system:<br /><br>- SF-36<br /><br>- Range of motion<br /><br>- Patient overall satisfaction with the outcome of the procedure on a NRS<br /><br>- Complications<br /><br>- Re-operations<br /><br>- Adverse events</p><br>