Pertrochanteric and Subtrochanteric Femur FracturesNCT00367406
Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
A study testing Gamma 3 nail versus ACE trochanteric nail in people with Pertrochanteric and Subtrochanteric Femur Fractures, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail. Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric and Subtrochanteric Femur Fractures
- What is being tested?
- Gamma 3 nail versus ACE trochanteric nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2006to Jul 2015
- Phase
- Interventional
- 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
Who may be able to join
- Pertrochanteric or subtrochanteric femur fracture
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail.
Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.
- Being tested
- Gamma 3 nail versus ACE trochanteric nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma 3 nail versus ACE trochanteric nailDevice
Comparing Gamma 3 nail versus ACE trochanteric nail
| Study group | Role | What they receive |
|---|---|---|
| Treatment with a Gamma 3 nail. | Experimental | Not described Receives: Device: Gamma 3 nail versus ACE trochanteric nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consolidation of the fracture
Measured: From surgery untill healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2006 (estimated)
- Study startNov 2006
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanteric and Subtrochanteric Femur FracturesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367406
- Sponsor's protocol ID
- 2006/280
- Status last verified
- Dec 2014
- First submitted
- 21 Aug 2006
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Gamma 3 Nail and ACE Trochanteric Nail
- ClinicalTrials.gov ID
- NCT00367406
- Acronym / sponsor ID
- 2006/280
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Nov 2006 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Aug 2006 (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.
Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail.
Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with a Gamma 3 nail. | Experimental | Device: Gamma 3 nail versus ACE trochanteric nail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pertrochanteric or subtrochanteric femur fracture
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gamma 3 nail versus ACE trochanteric nailComparing Gamma 3 nail versus ACE trochanteric nail | Device | Treatment with a Gamma 3 nail. |
Primary outcome
Consolidation of the fracture
Time frame: From surgery untill healing
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 20 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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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.
René Verdonk, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma 3 nail versus ACE trochanteric nail in people with Pertrochanteric and Subtrochanteric Femur Fractures, run by University Hospital, Ghent at 1 site in Belgium.
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 0 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Consolidation of the fracture (time frame: From surgery untill healing). 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 20 Dec 2022.