- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00779948
Dynamic Internal Fixation of Femoral Neck Fractures (DIFINE)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12207
- Krankenhaus Bethel
-
Ludwigshafen, Germany, 67071
- BGU Ludwigshafen
-
-
Baden-Wuerttemberg
-
Freiburg, Baden-Wuerttemberg, Germany, 79106
- Universitaetsklinikum Freiburg
-
-
Baden-Württemberg
-
Tübingen, Baden-Württemberg, Germany, 72076
- Berufsgenossenschaftliche Klinik
-
-
Hessen
-
Bad Hersfeld, Hessen, Germany, 36251
- Klinikum Bad Hersfeld GmbH
-
-
Nordrhein-Westfalen
-
Castrop-Rauxel, Nordrhein-Westfalen, Germany, 44577
- Evangelisches Krankenhaus
-
Muenster, Nordrhein-Westfalen, Germany, 48143
- Raphaelsklinik
-
Schwerte, Nordrhein-Westfalen, Germany, 58239
- Marienkrankenhaus Schwerte gGmbH
-
-
Sachsen
-
Annaberg-Buchholz, Sachsen, Germany, 09456
- Erzgebirgsklinikum Annaberg gGmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Targon FN
|
DHS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative Complication Rate
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Peter Helwig, Dr., University Hospital Freiburg
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAG-O-H-0806
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Femoral Neck Fracture
-
Sundsvall HospitalCompletedHip Fracture | Femoral Neck Fracture | Periprosthetic Femoral Fracture
-
University of NairobiCompletedHip Fracture | Femoral Neck Fracture | Fracture Neck of Femur
-
Zimmer BiometTerminatedFemur Fracture | Garden Grade I Subcapital Fracture of Femoral Neck | Garden Grade II Subcapital Fracture of Femoral Neck | Femur Fracture Intertrochanteric | Garden Grade III Subcapital Fracture of Femoral Neck | Garden Grade IV Subcapital Fracture of Femoral NeckUnited States
-
Mahidol UniversityCompletedHip Fracture | Femoral Neck Fracture | Intertrochanteric FractureThailand
-
Sundsvall HospitalCompletedHip Fracture | Femoral Neck Fracture
-
AO Innovation Translation CenterCompletedA Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures (FR_FNS)Hip Fracture | Femoral Neck FractureAustria, Switzerland, Germany
-
Danderyd HospitalActive, not recruitingHip Fracture | Femoral Neck FractureSweden
-
RenJi HospitalRecruiting
-
Sorlandet Hospital HFCompleted
-
Hartford HospitalZimmer BiometCompletedFemoral Neck FractureUnited States