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Dynamic Internal Fixation of Femoral Neck Fractures (DIFINE)
This study is currently recruiting participants.
Verified by Aesculap AG, April 2009
First Received: October 16, 2008   Last Updated: April 9, 2009   History of Changes
Sponsored by: Aesculap AG
Information provided by: Aesculap AG
ClinicalTrials.gov Identifier: NCT00779948
  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: Cohort, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 300
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (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

Contacts
Contact: Viktor Breul +49-7461-95-0 ext 2393 viktor.breul@aesculap.de

Locations
Germany
Vivantes Klinikum Spandau Not yet recruiting
Berlin, Germany, 13585
Contact: Helmut Taruttis, Dr.     +49-30-13013-0 ext 2051     helmut.taruttis@vivantes.de    
Principal Investigator: Helmut Taruttis, Dr.            
Martin-Luther-Krankenhaus Not yet recruiting
Berlin, Germany, 14193
Contact: Wolf Petersen, Dr.     +49-30-8955-0 ext 3025     w.petersen@mlk-berlin.de    
Principal Investigator: Wolf Petersen, Dr.            
Germany, Baden-Wuerttemberg
Universitaetsklinikum Freiburg Recruiting
Freiburg, Baden-Wuerttemberg, Germany, 79106
Contact: Peter Helwig, Dr.     +49-761-270-0 ext 2764     peter.helwig@uniklinik-freiburg.de    
Contact: Lukas Konstantinidis, Dr.     +49-761-270-0     lukas.konstantinidis@uniklinik-freiburg.de    
Principal Investigator: Peter Helwig, Dr.            
Sub-Investigator: Lukas Konstantinidis, Dr.            
Germany, Hessen
Klinikum Bad Hersfeld GmbH Recruiting
Bad Hersfeld, Hessen, Germany, 36251
Contact: Ruediger Volkmann, PD Dr.     +49-6621-88-0 ext 1571     ruediger.volkmann@klinikum-hef.de    
Principal Investigator: Andreas Mueller von Postel, Dr.            
Germany, Nordrhein-Westfalen
Raphaelsklinik Recruiting
Muenster, Nordrhein-Westfalen, Germany, 48143
Contact: Bernhard Egen, Dr.     +49-251-5007-0 ext 4094     b.egen@raphaelsklinik.de    
Contact: Y. Kollrack, Dr.     +49-251-5007-0        
Principal Investigator: Bernhard Egen, Dr.            
Sub-Investigator: Y. Kollrack, Dr.            
Marienkrankenhaus Schwerte gGmbH Recruiting
Schwerte, Nordrhein-Westfalen, Germany, 58239
Contact: Walter Vosberg, Dr.     +49-2304-1090 ext 190     w.vosberg@marien-kh.de    
Contact: Theodorus Matziaris, Dr.     +49-2304-1090        
Principal Investigator: Walter Vosberg, Dr.            
Sub-Investigator: Theodorus Matziaris, Dr.            
Kreisklinikum Siegen - Haus Huettental Not yet recruiting
Siegen, Nordrhein-Westfalen, Germany, 57072
Contact: Michael Palm, Dr.     +49-271-705-0 ext 1101     m.palm@kreisklinikum-siegen.de    
Principal Investigator: Michael Palm, Dr.            
Klinikum Dortmund gGmbH, Klinikzentrum Nord Not yet recruiting
Dortmund, Nordrhein-Westfalen, Germany, 44145
Contact: Jens-Peter Stahl, Dr.     +49-231-953-0 ext 18400     jens-peter.stahl@klinikumdo.de    
Principal Investigator: Jens-Peter Stahl, Dr.            
Evangelisches Krankenhaus Recruiting
Castrop-Rauxel, Nordrhein-Westfalen, Germany, 44577
Contact: Christoph Wiemer, Dr.     +49-2305-102-0 ext 2231     c.wiemer@evk-castrop-rauxel.de    
Principal Investigator: Christoph Wiemer, Dr.            
Germany, Sachsen
Erzgebirgsklinikum Annaberg gGmbH Recruiting
Annaberg-Buchholz, Sachsen, Germany, 09456
Contact: Ulrich Wandt, Dr.     +49-3733-8016-0 ext 40     uch@ergebirgsklinikum.de    
Principal Investigator: Ulrich Wandt, Dr.            
Germany, Sachsen-Anhalt
Klinikum Magdeburg Not yet recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39130
Contact: Fred Draijer, PD Dr.     +49-391-791-0 ext 4400     fred.draijer@klinikum-magdeburg.de    
Contact: Rongelraths, Dr.     +49-391-791-0        
Principal Investigator: Fred Draijer, PD Dr.            
Sub-Investigator: Rongelraths, Dr.            
Sponsors and Collaborators
Aesculap AG
Investigators
Study Chair: Peter Helwig, Dr. University Hospital Freiburg
  More Information

No publications provided

Responsible Party: Aesculap AG ( Viktor Breul )
Study ID Numbers: AAG-O-H-0806
Study First Received: October 16, 2008
Last Updated: April 9, 2009
ClinicalTrials.gov Identifier: NCT00779948     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
 Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
 Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on September 01, 2009



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