Dynamic Internal Fixation of Femoral Neck Fractures - Full Text View

Sponsored by:	Aesculap AG & Co. KG
Information provided by:	Aesculap AG & Co. KG
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

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

Further study details as provided by Aesculap AG & Co. KG:

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

No Contacts or Locations Provided

More Information

Responsible Party:	Aesculap AG ( Anne Katrin Wacker )
Study ID Numbers:	AAG-O-H-0806
Study First Received:	October 16, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00779948
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aesculap AG & Co. KG:

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

ClinicalTrials.gov processed this record on January 14, 2009