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Dynamic Internal Fixation of Femoral Neck Fractures (DIFINE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00779948
First received: October 16, 2008
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Femoral Neck Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dynamic Internal Fixation of Femoral Neck Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Cumulative Complication Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Targon FN
DHS

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT00779948     History of Changes
Other Study ID Numbers: AAG-O-H-0806
Study First Received: October 16, 2008
Last Updated: July 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 22, 2013