Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedMarch 1, 2012
February 1, 2012
2 years
February 1, 2012
February 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
difference of metatarsal angles in degree post surgery and 6 months after surgery
up to 6 months
Study Arms (2)
degradable metallic device
EXPERIMENTALnon-degradable metallic device
ACTIVE COMPARATORInterventions
Comparison of two metallic implantable fracture compressing screws
Comparison of two metallic implantable fracture compressing screws
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Syntellix AGlead
Study Sites (1)
Clinic for Orthopaedic Surgery (in the Annastift Hospital)
Hanover, Lower Saxony, 30625, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Windhagen, Prof., MD
Clinic for Orthopaedic Surgery (in the Annastift Hospital)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 17, 2012
Study Start
February 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 1, 2012
Record last verified: 2012-02