Hallux ValgusNCT00455676
Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus
A study testing Chevron osteotomy versus Scarf osteotomy in people with Hallux Valgus, run by University Hospital, Limoges at 1 site in France.
Trial summary
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data. All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges : Scarf or Jonhson (chevron) osteotomy Experienced surgeon : Pr ARNAUD, Pr MABIT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Chevron osteotomy versus Scarf osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Nov 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges.
- Scarf or Johnson (Chevron) osteotomy,
- Experienced surgeon : Pr MABIT, Pr ARNAUD, Pr CHARISSOUX.
- Age of Patients > 18 years.
Who cannot join
- Hallux valgus wich wasn't operated by these surgeons.
- No consentment
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges :
- Scarf or Jonhson (chevron) osteotomy
- Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.
Read the detailed description
Prospective assessmentfor all patients with an average follow up of 5 years :
- Groulier score scale (similar to AOFAS score rating)
- X-rays data
- Clinical evaluation
- Pedoscopic data.
- Conditions
- Hallux Valgus
- Being tested
- Chevron osteotomy versus Scarf osteotomy
- Keywords
- Scarf Osteotomy, Chevron Osteotomy, Comparison
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chevron osteotomy versus Scarf osteotomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
Secondary outcomes (3)
Extension of chevron osteotomy indication. Check of results for one-year more operated patients by chevron osteotomy.
Comparaison of both techniques concerning post-operative complication.
Search of significative difference about satisfaction of patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJun 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Chistrian MABIT, MD, Principal investigator, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455676
- Sponsor's protocol ID
- I06020
- Status last verified
- Dec 2008
- First submitted
- 3 Apr 2007
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus
- ClinicalTrials.gov ID
- NCT00455676
- Acronym / sponsor ID
- I06020
- Conditions
- Hallux Valgus
- Keywords
- Scarf Osteotomy, Chevron Osteotomy, Comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Apr 2007 (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.
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges :
- Scarf or Jonhson (chevron) osteotomy
- Experienced surgeon : Pr ARNAUD, Pr MABIT or Pr CHARISSOUX.
Detailed description
Prospective assessmentfor all patients with an average follow up of 5 years :
- Groulier score scale (similar to AOFAS score rating)
- X-rays data
- Clinical evaluation
- Pedoscopic data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients operated for hallux valgus for 01/01/99 to 31/12/03 in the department of bone surgery CHU Limoges.
- Age of Patients > 18 years.
Key exclusion criteria (2 listed)
- Hallux valgus wich wasn't operated by these surgeons.
- No consentment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chevron osteotomy versus Scarf osteotomy | Procedure or surgery | – |
Primary outcome
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
3 secondary outcomes
Extension of chevron osteotomy indication. Check of results for one-year more operated patients by chevron osteotomy.
Comparaison of both techniques concerning post-operative complication.
Search of significative difference about satisfaction of patients.
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 30 Dec 2008.
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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.
Chistrian MABIT, MD principal investigator
CHU Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chevron osteotomy versus Scarf osteotomy in people with Hallux Valgus, run by University Hospital, Limoges at 1 site in France.
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 4 inclusion and 2 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 30 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.. 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 30 Dec 2008.