Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

Hallux Valgus Clinical Trial

Official title:

Chevron Osteotomy Versus SCARF Osteotomy in the Treatment of Hallux Valgus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455676
• Other study ID #: I06020
• Status: Completed
• Phase: N/A
• First received: April 3, 2007
• Last updated: December 29, 2008
• Start date: June 2006
• Est. completion date: November 2006

Study information

• Verified date: December 2008
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 or Pr CHARISSOUX.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Procedure:
• Chevron osteotomy versus Scarf osteotomy

Locations

Country	Name	City	State
France	Department of Bone Surgery	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between two techniques of osteotomy wich are more or less invasive : two criterias : clinical data and x-rays data.
Secondary	Extension of chevron osteotomy indication. Check of results for one-year more operated patients by chevron osteotomy.
Secondary	Comparaison of both techniques concerning post-operative complication.
Secondary	Search of significative difference about satisfaction of patients.