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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942032
First Posted: July 20, 2009
Last Update Posted: April 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Synthes Inc.
Information provided by:
AO Clinical Investigation and Documentation
  Purpose
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
Hindfoot Arthrodesis Hindfoot Pathologies

Study Type: Observational
Study Design: 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.

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 39
Study Start Date: May 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: July 17, 2009
First Posted: July 20, 2009
Last Update Posted: April 7, 2011
Last Verified: April 2011