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

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ClinicalTrials.gov Identifier: NCT01535144
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : March 1, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Device: Fracture compressing screw ZfW 102 Königsee Implantate GmbH Device: Fracture compressing screw titanium Königsee Implantate GmbH Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. difference of metatarsal angles in degree post surgery and 6 months after surgery [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: Syntellix AG
ClinicalTrials.gov Identifier: NCT01535144     History of Changes
Other Study ID Numbers: syn09-01
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired