Hallux Valgus
Conditions
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.
Interventions
DEVICEFracture compressing screw ZfW 102 Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
DEVICEFracture compressing screw titanium Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
Sponsors
Syntellix AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| difference of metatarsal angles in degree post surgery and 6 months after surgery | up to 6 months |
Countries
Germany
Outcome results
None listed