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

Syntellix

Status: Completed

Conditions: Hallux Valgus

Treatments: Device: Fracture compressing screw titanium Königsee Implantate GmbH; Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01535144

syn09-01

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

degradable metallic device

Experimental group

Treatment:

Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH

non-degradable metallic device

Active Comparator group

Treatment:

Device: Fracture compressing screw titanium Königsee Implantate GmbH