Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
Not Applicable
Completed
- Conditions
- Hallux Valgus
- Registration Number
- NCT01535144
- Lead Sponsor
- Syntellix AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method difference of metatarsal angles in degree post surgery and 6 months after surgery up to 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinic for Orthopaedic Surgery (in the Annastift Hospital)
🇩🇪Hanover, Lower Saxony, Germany
Clinic for Orthopaedic Surgery (in the Annastift Hospital)🇩🇪Hanover, Lower Saxony, Germany