Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device

Hallux Valgus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535144
• Other study ID #: syn09-01
• Status: Completed
• Phase: N/A
• First received: February 1, 2012
• Last updated: February 29, 2012
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Syntellix AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to show the equivalence of a new degradable metallic device to a non-degradable metallic device in patients with Hallux Valgus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Female and male patients with an age of 40 to 79 years at the day of surgery

• Symptomatic Hallux Valgus

• Radiological criterium area of proximal joint angle

• Normal motorically functions

• Female patients of childbearing age must be using two reliable contraception methods

Exclusion Criteria:

• Previous bone and/or soft tissue surgeries of the the first metatarsal of the respective foot

• BMI > 32

• Cysts of the first metatarsal of the respective foot

• Neurological disorders with modified motorically functions

• Clinical evidence of osteoporosis

• Chronic renal impairment

• Known hypersensitivity to components of the implants

• Regular administration of medications containing the metallic elements of the degradable implant

• Pregnant or lactating women

• Current participation in another clinical trial or within 30 days before surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Device:
• Fracture compressing screw ZfW 102 Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
• Fracture compressing screw titanium Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws

Locations

Country	Name	City	State
Germany	Clinic for Orthopaedic Surgery (in the Annastift Hospital)	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Syntellix AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of metatarsal angles in degree post surgery and 6 months after surgery		up to 6 months	No