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

February 29, 2012 updated by: Syntellix AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference of metatarsal angles in degree post surgery and 6 months after surgery
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syntellix AG

Investigators

  • Principal Investigator: Henning Windhagen, Prof., MD, Clinic for Orthopaedic Surgery (in the Annastift Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • syn09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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