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

This study has been completed.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00942032
First received: July 17, 2009
Last updated: April 6, 2011
Last verified: April 2011
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 17, 2009
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on October 23, 2014