Dynamic Internal Fixation of Femoral Neck Fractures (DIFINE)

August 5, 2013 updated by: Aesculap AG
Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.

Study Overview

Status

Completed

Conditions

Detailed Description

Two implant systems are mainly used for internal fixation: canulated screws and plate-screw-systems. Regarding the latter, the dynamic hip screw systems (DHS)represent the most frequently used devices.

Targon FN (Aesculap) is a new plate-screw system and available on the market since 2007. In contrast to the DHS, which uses only one telescrew, the Targon FN provides up to four telescrews.

With this registry, we want to evaluate the results of Targon FN compared with DHS systems.

Study Type

Observational

Enrollment (Actual)

171

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
      • Berlin, Germany, 12207
        • Krankenhaus Bethel
      • Ludwigshafen, Germany, 67071
        • BGU Ludwigshafen
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Berufsgenossenschaftliche Klinik
    • Hessen
      • Bad Hersfeld, Hessen, Germany, 36251
        • Klinikum Bad Hersfeld GmbH
    • Nordrhein-Westfalen
      • Castrop-Rauxel, Nordrhein-Westfalen, Germany, 44577
        • Evangelisches Krankenhaus
      • Muenster, Nordrhein-Westfalen, Germany, 48143
        • Raphaelsklinik
      • Schwerte, Nordrhein-Westfalen, Germany, 58239
        • Marienkrankenhaus Schwerte gGmbH
    • Sachsen
      • Annaberg-Buchholz, Sachsen, Germany, 09456
        • Erzgebirgsklinikum Annaberg gGmbH

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Patients

Description

Inclusion Criteria:

  • men >= 60 years, women >= 55 years
  • femoral neck fractures needing surgical therapy
  • femoral head preserving indication
  • Living in a 100 km Radius from Hospital

Exclusion Criteria:

  • Patient not able to walk
  • Previous fracture or surgery on ipsilateral hip
  • pathological fracture
  • open fracture

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

Cohorts and Interventions

Group / Cohort
Targon FN
DHS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative Complication Rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Aesculap AG

Investigators

  • Study Chair: Peter Helwig, Dr., University Hospital Freiburg

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

December 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 5, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-0806

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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