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

NCT ID: NCT01535144

Last Updated: 2012-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Hallux Valgus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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degradable metallic device

Group Type EXPERIMENTAL

Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Intervention Type DEVICE

Comparison of two metallic implantable fracture compressing screws

non-degradable metallic device

Group Type ACTIVE_COMPARATOR

Fracture compressing screw titanium Königsee Implantate GmbH

Intervention Type DEVICE

Comparison of two metallic implantable fracture compressing screws

Interventions

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Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Comparison of two metallic implantable fracture compressing screws

Intervention Type DEVICE

Fracture compressing screw titanium Königsee Implantate GmbH

Comparison of two metallic implantable fracture compressing screws

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntellix AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Windhagen, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Locations

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Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Hanover, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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syn09-01

Identifier Type: -

Identifier Source: org_study_id

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