NCT00779948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

3.1 years

First QC Date

October 16, 2008

Last Update Submit

August 5, 2013

Conditions

Femoral Neck Fracture

Keywords

Femoral Neck FractureInternal FixationDynamic Hip Screw

Outcome Measures

Primary Outcomes (1)

  • Cumulative Complication Rate

    1 year

Secondary Outcomes (1)

  • Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)

    1 year

Study Arms (2)

Targon FN

DHS

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Patients

You may qualify if:

  • men \>= 60 years, women \>= 55 years
  • femoral neck fractures needing surgical therapy
  • femoral head preserving indication
  • Living in a 100 km Radius from Hospital

You may not qualify if:

  • Patient not able to walk
  • Previous fracture or surgery on ipsilateral hip
  • pathological fracture
  • open fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Berufsgenossenschaftliche Klinik

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum Bad Hersfeld GmbH

Bad Hersfeld, Hesse, 36251, Germany

Location

Evangelisches Krankenhaus

Castrop-Rauxel, North Rhine-Westphalia, 44577, Germany

Location

Raphaelsklinik

Münster, North Rhine-Westphalia, 48143, Germany

Location

Marienkrankenhaus Schwerte gGmbH

Schwerte, North Rhine-Westphalia, 58239, Germany

Location

Erzgebirgsklinikum Annaberg gGmbH

Annaberg-Buchholz, Saxony, 09456, Germany

Location

Krankenhaus Bethel

Berlin, State of Berlin, 12207, Germany

Location

BGU Ludwigshafen

Ludwigshafen, 67071, Germany

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Peter Helwig, Dr.

    University Hospital Freiburg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 24, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2012

Study Completion

February 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations

DE(9)