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

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ClinicalTrials.gov Identifier: NCT00942032
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : April 7, 2011
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
AO Clinical Investigation and Documentation

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.

Condition or disease
Hindfoot Arthrodesis Hindfoot Pathologies

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 Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.
Study Start Date : May 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) [ Time Frame: More than 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will be identified from the study sites' medical records, information systems, and OR logs. The responsible local investigator or co-investigator at each study site will approach patients by letter or phone, and inquire about their interest in participating in this study.
Criteria

Inclusion Criteria:

  • HAN fusion procedure ≥ 12 months before entering the study.
  • Written or oral informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942032


Locations
United States, California
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104-2499
France
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Germany
Charité Berlin, Campus Virchow Klinikum
Berlin, Germany, 13353
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Sweden
Stockholms Fotkirurgklinik Sophiahemmet
Stockholm, Sweden, 11486
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
Investigators
Study Director: Beate P. Hanson, MD Ao Clinical Investigation and Documentation, Davos, Switzerland
Principal Investigator: Andrew K. Sands, MD St. Vincent's Hospital, Foot and Ankle Surgery

Responsible Party: Andrew K. Sands, MD, St. Vincent's Hospital, Foot and Ankle Surgery
ClinicalTrials.gov Identifier: NCT00942032     History of Changes
Other Study ID Numbers: HAN-09
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011