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

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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture compressing screw ZfW 102 Königsee Implantate GmbH

Device

Comparison of two metallic implantable fracture compressing screws

Fracture compressing screw titanium Königsee Implantate GmbH

Device

Comparison of two metallic implantable fracture compressing screws

Primary outcomes

difference of metatarsal angles in degree post surgery and 6 months after surgery

Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Syntellix AG

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Feb 17, 2012
Registry last updated: Mar 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed