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

Not Applicable

Completed

• Conditions: Hallux Valgus
• Interventions: Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH; Device: Fracture compressing screw titanium Königsee Implantate GmbH

• Registration Number: NCT01535144
• Lead Sponsor: Syntellix AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
degradable metallic device	Fracture compressing screw ZfW 102 Königsee Implantate GmbH	-
non-degradable metallic device	Fracture compressing screw titanium Königsee Implantate GmbH	-

Primary Outcome Measures

Name	Time	Method
difference of metatarsal angles in degree post surgery and 6 months after surgery	up to 6 months

Trial Locations

Locations (1)

Clinic for Orthopaedic Surgery (in the Annastift Hospital); 🇩🇪 Hanover, Lower Saxony, Germany