Femoral Neck FractureDIFINENCT00779948
Dynamic Internal Fixation of Femoral Neck Fractures
An observational study of Femoral Neck Fracture, run by Aesculap AG at 9 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Femoral Neck Fracture
- How many people
- 171 participants
- Where
- 9 sitesGermany
- Study dates
- Dec 2008to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Patients
Who may be able to join
- men >= 60 years, women >= 55 years
- femoral neck fractures needing surgical therapy
- femoral head preserving indication
- Living in a 100 km Radius from Hospital
Who cannot join
- Patient not able to walk
- Previous fracture or surgery on ipsilateral hip
- pathological fracture
- open fracture
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Erzgebirgsklinikum Annaberg gGmbH
Annaberg-Buchholz, Saxony, 09456
Klinikum Bad Hersfeld GmbH
Bad Hersfeld, Hesse, 36251
Krankenhaus Bethel
Berlin, State of Berlin, 12207
Evangelisches Krankenhaus
Castrop-Rauxel, North Rhine-Westphalia, 44577
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
BGU Ludwigshafen
Ludwigshafen, 67071
Raphaelsklinik
Münster, North Rhine-Westphalia, 48143
Marienkrankenhaus Schwerte gGmbH
Schwerte, North Rhine-Westphalia, 58239
Berufsgenossenschaftliche Klinik
Tübingen, Baden-Wurttemberg, 72076
About this study
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.
Read the 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.
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fracture, Internal Fixation, Dynamic Hip Screw
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Targon FN | Not described | |
| DHS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Complication Rate
Measured: 1 year
Secondary outcomes (1)
Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Helwig, Dr., Study chair, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779948
- Sponsor's protocol ID
- AAG-O-H-0806
- Acronym
- DIFINE
- Status last verified
- Aug 2013
- First submitted
- 16 Oct 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Internal Fixation of Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT00779948
- Acronym / sponsor ID
- DIFINE / AAG-O-H-0806
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fracture, Internal Fixation, Dynamic Hip Screw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targon FN | – | – |
| DHS | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Patients
Key inclusion criteria (4 listed)
- men >= 60 years, women >= 55 years
- femoral neck fractures needing surgical therapy
- femoral head preserving indication
- Living in a 100 km Radius from Hospital
Key exclusion criteria (4 listed)
- Patient not able to walk
- Previous fracture or surgery on ipsilateral hip
- pathological fracture
- open fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative Complication Rate
Time frame: 1 year
1 secondary outcome
Course of Surgery Mobilization Radiology functional Results (SF-12, IOWA Hip Score)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Helwig, Dr. study chair
University Hospital Freiburg
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture, run by Aesculap AG at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Complication Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.