Hindfoot ArthrodesisNCT00942032
Clinical Experience With the Hindfoot Arthrodesis Nail for the Surgical Treatment of Ankle and Hindfoot Pathologies
An observational study of Hindfoot Arthrodesis and Hindfoot Pathologies, run by AO Clinical Investigation and Publishing Documentation at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hindfoot Arthrodesis, Hindfoot Pathologies
- How many people
- 39 participants
- Where
- 7 sitesin 4 countries
- Study dates
- May 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- HAN fusion procedure ≥ 12 months before entering the study.
- Written or oral informed consent.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Eisenhower Medical Center
Rancho Mirage, California, 92270
Harborview Medical Center
Seattle, Washington, 98104-2499
Germany2 sites
Charité Berlin, Campus Virchow Klinikum
Berlin, 13353
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
About this study
Official title: Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.
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.
Read the 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.
- Conditions
- Hindfoot Arthrodesis, Hindfoot Pathologies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: More than 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hindfoot ArthrodesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc.
- Investigators
- Beate P. Hanson, MD, Study director, Ao Clinical Investigation and Documentation, Davos, SwitzerlandAndrew K. Sands, MD, Principal investigator, St. Vincent's Hospital, Foot and Ankle Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942032
- Sponsor's protocol ID
- HAN-09
- Status last verified
- Apr 2011
- First submitted
- 17 Jul 2009
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.
- ClinicalTrials.gov ID
- NCT00942032
- Acronym / sponsor ID
- HAN-09
- Conditions
- Hindfoot Arthrodesis, Hindfoot Pathologies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc.
- Study start
- May 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- HAN fusion procedure ≥ 12 months before entering the study.
- Written or oral informed consent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate P. Hanson, MD study director
Ao Clinical Investigation and Documentation, Davos, Switzerland
Andrew K. Sands, MD principal investigator
St. Vincent's Hospital, Foot and Ankle Surgery
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hindfoot Arthrodesis and Hindfoot Pathologies, run by AO Clinical Investigation and Publishing Documentation at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.