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NCT00779948 Clinical Trial

Dynamic Internal Fixation of Femoral Neck Fractures

Femoral Neck Fracture Clinical Trial

— DIFINE  

Official title:
Dynamic Internal Fixation of Femoral Neck Fractures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00779948
Other study ID # AAG-O-H-0806
Secondary ID
Status Completed
Phase N/A
First received October 16, 2008
Last updated August 5, 2013
Start date December 2008
Est. completion date February 2013

Study information
Verified date August 2013
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date February 2013
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Erzgebirgsklinikum Annaberg gGmbH Annaberg-Buchholz Sachsen
Germany Klinikum Bad Hersfeld GmbH Bad Hersfeld Hessen
Germany Krankenhaus Bethel Berlin
Germany Evangelisches Krankenhaus Castrop-Rauxel Nordrhein-Westfalen
Germany Universitaetsklinikum Freiburg Freiburg Baden-Wuerttemberg
Germany BGU Ludwigshafen Ludwigshafen
Germany Raphaelsklinik Muenster Nordrhein-Westfalen
Germany Marienkrankenhaus Schwerte gGmbH Schwerte Nordrhein-Westfalen
Germany Berufsgenossenschaftliche Klinik Tübingen Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative Complication Rate 1 year No
Secondary Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score) 1 year No
See also
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Recruiting NCT02148848 - Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty Phase 4
Completed NCT01644227 - Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk N/A
Active, not recruiting NCT02901938 - Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients N/A