Chevron Osteotomy Versus SCARF Osteotomy in the Treatment... | NCT00455676

Studies
Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

NCT00455676

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Dec 30, 2008Estimated

Enrollment

Phase

Not Applicable

Conditions

Hallux Valgus

Interventions

Chevron osteotomy versus Scarf osteotomy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Apr 3, 2007

First Submission Date that Met QC Criteria

Apr 3, 2007

First Posted Date

Apr 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2008

Last Update Posted Date

Dec 30, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Chevron osteotomy versus Scarf osteotomy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Hallux valgus wich wasn't operated by these surgeons.
No consentment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chistrian MABIT, MD	CHU Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Bone Surgery		Limoges		87000	France

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided