Hip FracturesNCT02657902
Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?
An observational study of Hip Fractures, run by Medical University of Vienna.
Trial summary
The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fractures were treated with a Gamma 3 intramedullary nail and Fractures were treated with a Gamma 3 intramedullary nail + U-Blade
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)
Who may be able to join
- OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)
Who cannot join
- Patients with pathological fractures
- Patients treated with a long gamma nail were excluded
About this study
Official title: Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?
The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.
- Conditions
- Hip Fractures
- Being tested
- Fractures were treated with a Gamma 3 intramedullary nail, Fractures were treated with a Gamma 3 intramedullary nail + U-Blade
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractures were treated with a Gamma 3 intramedullary nailProcedure or surgery
Fractures were treated with a Gamma 3 intramedullary nail + U-BladeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gamma 3 Nail | Fractures that were treated with a Gamma 3 nail Receives: Procedure: Fractures were treated with a Gamma 3 intramedullary nail | |
| Gamma 3 Nail + U-Blade | Fractures that were treated with a Gamma 3 nail and additional with antirotation U-blade lag screws. Receives: Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutout rate
Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw
Measured: 3 months after intervention
Secondary outcomes (1)
Mobility
Mobility of the patients 3 months after intervention measured with the Parker mobility score
Measured: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2009
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657902
- Sponsor's protocol ID
- 1960/2015
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?
- ClinicalTrials.gov ID
- NCT02657902
- Acronym / sponsor ID
- 1960/2015
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2015 (actual)
- First posted
- 18 Jan 2016 (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.
The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma 3 Nail | – | Procedure: Fractures were treated with a Gamma 3 intramedullary nailFractures that were treated with a Gamma 3 nail |
| Gamma 3 Nail + U-Blade | – | Procedure: Fractures were treated with a Gamma 3 intramedullary nail + U-BladeFractures that were treated with a Gamma 3 nail and additional with antirotation U-blade lag screws. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)
Key inclusion criteria (1 listed)
- OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)
Key exclusion criteria (2 listed)
- Patients with pathological fractures
- Patients treated with a long gamma nail were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractures were treated with a Gamma 3 intramedullary nail | Procedure or surgery | Gamma 3 Nail |
| Fractures were treated with a Gamma 3 intramedullary nail + U-Blade | Procedure or surgery | Gamma 3 Nail + U-Blade |
Primary outcome
Cutout rate
Time frame: 3 months after intervention
Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw
1 secondary outcome
Mobility
Time frame: 3 months after intervention
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 18 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Medical University of Vienna.
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 1 inclusion and 2 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cutout rate (time frame: 3 months after intervention). 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 18 Jan 2016.