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
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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COMPLETED
NA
26 participants
INTERVENTIONAL
2010-02-28
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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degradable metallic device
Fracture compressing screw ZfW 102 Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
non-degradable metallic device
Fracture compressing screw titanium Königsee Implantate GmbH
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
Fracture compressing screw titanium Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
79 Years
ALL
No
Sponsors
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Syntellix AG
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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syn09-01
Identifier Type: -
Identifier Source: org_study_id
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