NCT00942032

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

1.9 years

First QC Date

July 17, 2009

Last Update Submit

April 6, 2011

Conditions

Hindfoot ArthrodesisHindfoot Pathologies

Outcome Measures

Primary Outcomes (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.

    More than 1 year

Secondary Outcomes (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)

    More than 1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Harborview Medical Center

Seattle, Washington, 98104-2499, United States

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Charité Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Stockholms Fotkirurgklinik Sophiahemmet

Stockholm, 11486, Sweden

Location

Study Officials

  • Beate P. Hanson, MD

    Ao Clinical Investigation and Documentation, Davos, Switzerland

    STUDY DIRECTOR

  • Andrew K. Sands, MD

    St. Vincent's Hospital, Foot and Ankle Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 20, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

FR(1)US(3)DE(2)SE(1)