Dynamic Internal Fixation of Femoral Neck Fractures

Completed

• Conditions: Femoral Neck Fracture

• Registration Number: NCT00779948
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-23
• Study First Posted: 2008-10-24
• Study Start: 2008-12
• Primary Completion: 2012-01
• Study Completion: 2013-02
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative Complication Rate	1 year

Secondary Outcome Measures

Name	Time	Method
Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)	1 year

Trial Locations

Locations (9)

Universitaetsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany

Berufsgenossenschaftliche Klinik; 🇩🇪 Tübingen, Baden-Württemberg, Germany

BGU Ludwigshafen; 🇩🇪 Ludwigshafen, Germany

Raphaelsklinik; 🇩🇪 Muenster, Nordrhein-Westfalen, Germany

Evangelisches Krankenhaus; 🇩🇪 Castrop-Rauxel, Nordrhein-Westfalen, Germany

Klinikum Bad Hersfeld GmbH; 🇩🇪 Bad Hersfeld, Hessen, Germany

Marienkrankenhaus Schwerte gGmbH; 🇩🇪 Schwerte, Nordrhein-Westfalen, Germany

Erzgebirgsklinikum Annaberg gGmbH; 🇩🇪 Annaberg-Buchholz, Sachsen, Germany

Krankenhaus Bethel; 🇩🇪 Berlin, Germany