Intertrochanteric Femoral FracturesNCT01173744
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
A study testing Gamma-3 Nail and DHS in people with Intertrochanteric Femoral Fractures, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS). This is a prospective study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intertrochanteric Femoral Fractures
- What is being tested?
- Gamma-3 Nail and DHS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Jul 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute Intertrochanteric fracture - A1-32 AO/OTA
- Abbreviated mental score >6
- Community ambulator (pre-fracture state)
Who cannot join
- Previous arthritis
- Pathological fracture
- Chronic corticosteroid use
- Concomitant lower extremity fractures
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
E. WOlfson medical center
Holon, 58100
Dror Lakstein, MD, ++972-3-5028383, drorale@gmail.com
Dror Lakstein, MD
About this study
The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).
This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.
- Conditions
- Intertrochanteric Femoral Fractures
- Being tested
- Gamma-3 Nail, DHS
- Keywords
- Intertrochanteric femoral fractures - unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma-3 NailDevice
Gamma-3 Nail (stryker)
DHSDevice
DHS (Zimmer)
| Study group | Role | What they receive |
|---|---|---|
| Gamma-3 Nail | Experimental | Not described Receives: Device: Gamma-3 Nail |
| DHS | Active comparator | Not described Receives: Device: DHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome as measured by the Merle d'Aubigne and Postel 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 posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric Femoral 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173744
- Sponsor's protocol ID
- 0076-10-WOMC
- Status last verified
- Jul 2010
- First submitted
- 27 Jul 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures
- ClinicalTrials.gov ID
- NCT01173744
- Acronym / sponsor ID
- 0076-10-WOMC
- Conditions
- Intertrochanteric Femoral Fractures
- Keywords
- Intertrochanteric femoral fractures - unstable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Aug 2010 (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 objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS).
This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma-3 Nail | Experimental | Device: Gamma-3 Nail |
| DHS | Active comparator | Device: DHS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Intertrochanteric fracture - A1-32 AO/OTA
- Abbreviated mental score >6
- Community ambulator (pre-fracture state)
Key exclusion criteria (4 listed)
- Previous arthritis
- Pathological fracture
- Chronic corticosteroid use
- Concomitant lower extremity fractures
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 NailGamma-3 Nail (stryker) | Device | Gamma-3 Nail |
| DHSDHS (Zimmer) | Device | DHS |
Primary outcome
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2011.
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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.
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 and DHS in people with Intertrochanteric Femoral Fractures, run by Wolfson Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Jun 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror Lakstein, MD (++972-3-5028383, drorale@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome as measured by the Merle d'Aubigne and Postel hip score (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 17 Jun 2011.