NCT00942032CompletedNot Applicable
Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.
AO Clinical Investigation and Publishing Documentation7 sites in 4 countries39 target enrollmentStarted: May 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 7
- Primary Endpoint
- 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.
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HAN fusion procedure ≥ 12 months before entering the study.
- •Written or oral informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: More than 1 year
Secondary Outcomes
- 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)
Investigators
Study Sites (7)
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