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

NCT ID: NCT00942032

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hindfoot Arthrodesis Hindfoot Pathologies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Synthes Inc.

INDUSTRY

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

St. Vincent's Hospital, Foot and Ankle Surgery

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beate P. Hanson, MD

Role: STUDY_DIRECTOR

Ao Clinical Investigation and Documentation, Davos, Switzerland

Andrew K. Sands, MD

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Hospital, Foot and Ankle Surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Harborview Medical Center

Seattle, Washington, United States

Site Status

Centre Hospitalier Universitaire d'Angers

Angers, , France

Site Status

Charité Berlin, Campus Virchow Klinikum

Berlin, , Germany

Site Status

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Stockholms Fotkirurgklinik Sophiahemmet

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States France Germany Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HAN-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Subtalar Extra-articular Screw Arthroereisis
NCT06389253 NOT_YET_RECRUITING