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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syntellix AG
ClinicalTrials.gov Identifier:
NCT01535144
First received: February 1, 2012
Last updated: February 29, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Hallux Valgus
Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH
Device: Fracture compressing screw titanium Königsee Implantate GmbH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Syntellix AG:

Primary Outcome Measures:
  • difference of metatarsal angles in degree post surgery and 6 months after surgery [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: degradable metallic device Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws
Active Comparator: non-degradable metallic device Device: Fracture compressing screw titanium Königsee Implantate GmbH
Comparison of two metallic implantable fracture compressing screws

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535144

Locations
Germany
Clinic for Orthopaedic Surgery (in the Annastift Hospital)
Hanover, Lower Saxony, Germany, 30625
Sponsors and Collaborators
Syntellix AG
Investigators
Principal Investigator: Henning Windhagen, Prof., MD Clinic for Orthopaedic Surgery (in the Annastift Hospital)
  More Information

No publications provided

Responsible Party: Syntellix AG
ClinicalTrials.gov Identifier: NCT01535144     History of Changes
Other Study ID Numbers: syn09-01
Study First Received: February 1, 2012
Last Updated: February 29, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 22, 2014