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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014