Clinical Experience With the Hindfoot Arthrodesis Nail for the Surgical Treatment of Ankle and Hindfoot Pathologies

Hindfoot Arthrodesis Clinical Trial

Official title:

Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942032
• Other study ID #: HAN-09
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: April 6, 2011
• Start date: May 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics CommitteeGermany: Ethics CommissionFrance: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.

Description:

The HAN (Synthes) is a newly designed, titanium nail for trans-calcaneal, retrograde hindfoot fusion. The lateral bend allows an entry site in the center of the lateral column of the calcaneus, thus minimizing the risk of iatrogenic injury of the plantar neurovascular bundle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HAN fusion procedure = 12 months before entering the study.

• Written or oral informed consent.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hindfoot Arthrodesis
• Hindfoot Pathologies

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Angers	Angers
Germany	Charité Berlin, Campus Virchow Klinikum	Berlin
Germany	Universitätsklinikum Carl Gustav Carus	Dresden
Sweden	Stockholms Fotkirurgklinik Sophiahemmet	Stockholm
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	Synthes Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.		More than 1 year	No
Secondary	Technical and surgical details Patient-centered endpoints (e.g., function as assessed by AAOS Foot and Ankle Outcomes Questionnaire (AAOS-FAOQ) score and the SF-36 Health Survey)		More than 1 year	No