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Dynamic Internal Fixation of Femoral Neck Fractures (DIFINE)

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ClinicalTrials.gov Identifier: NCT00779948
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:
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.

Condition or disease
Femoral Neck Fracture

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
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Internal Fixation of Femoral Neck Fractures
Study Start Date : December 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Targon FN
DHS



Primary Outcome Measures :
  1. Cumulative Complication Rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score) [ Time Frame: 1 year ]


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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Patients
Criteria

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

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): NCT00779948


Locations
Germany
Universitaetsklinikum Freiburg
Freiburg, Baden-Wuerttemberg, Germany, 79106
Berufsgenossenschaftliche Klinik
Tübingen, Baden-Württemberg, Germany, 72076
Klinikum Bad Hersfeld GmbH
Bad Hersfeld, Hessen, Germany, 36251
Evangelisches Krankenhaus
Castrop-Rauxel, Nordrhein-Westfalen, Germany, 44577
Raphaelsklinik
Muenster, Nordrhein-Westfalen, Germany, 48143
Marienkrankenhaus Schwerte gGmbH
Schwerte, Nordrhein-Westfalen, Germany, 58239
Erzgebirgsklinikum Annaberg gGmbH
Annaberg-Buchholz, Sachsen, Germany, 09456
Krankenhaus Bethel
Berlin, Germany, 12207
BGU Ludwigshafen
Ludwigshafen, Germany, 67071
Sponsors and Collaborators
Aesculap AG
Investigators
Study Chair: Peter Helwig, Dr. University Hospital Freiburg

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT00779948     History of Changes
Other Study ID Numbers: AAG-O-H-0806
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Aesculap AG:
Femoral Neck Fracture
Internal Fixation
Dynamic Hip Screw

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries