Intertrochanteric Fractures of the HipNCT01238068
Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures
A study testing gamma nail stryker in people with Intertrochanteric Fractures of the Hip, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intertrochanteric Fractures of the Hip
- What is being tested?
- gamma nail stryker
- 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
- Nov 2010to Nov 2011
- 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
- patients diagozied with acute intertrochantric unstable fracture
- a minimum minimental score of 6
- ability to walk 500 meters indepedently
Who cannot join
- pathological fracture
- multiple fractures
- neurological conditions
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Medical center
Tel Aviv
ortal sgal, MD, ortal_San@yahoo.com
About this study
The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.
- Conditions
- Intertrochanteric Fractures of the Hip
- Being tested
- gamma nail stryker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma nail strykerDevice
for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw
| Study group | Role | What they receive |
|---|---|---|
| Gamma nail, fracture stabilization, better walking | Active comparator | Not described Receives: Device: gamma nail stryker |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip function score
at the last clinical visit (1 year) the patient will perform hip score testing and record.
Measured: 1 year
Secondary outcomes (1)
x-ray, surgical outcome
in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record
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 posted10 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intertrochanteric Fractures of the HipStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238068
- Sponsor's protocol ID
- TAMSC-10-OS-10-357-CTIL
- Status last verified
- Oct 2010
- First submitted
- 26 Oct 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
Publications
Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.
PubMed 35080771
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures
- ClinicalTrials.gov ID
- NCT01238068
- Acronym / sponsor ID
- TAMSC-10-OS-10-357-CTIL
- Conditions
- Intertrochanteric Fractures of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 10 Nov 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 study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gamma nail, fracture stabilization, better walking | Active comparator | Device: gamma nail stryker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients diagozied with acute intertrochantric unstable fracture
- a minimum minimental score of 6
- ability to walk 500 meters indepedently
Key exclusion criteria (3 listed)
- pathological fracture
- multiple fractures
- neurological conditions
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 nail strykerfor acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw | Device | Gamma nail, fracture stabilization, better walking |
Primary outcome
hip function score
Time frame: 1 year
at the last clinical visit (1 year) the patient will perform hip score testing and record.
1 secondary outcome
x-ray, surgical outcome
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 10 Nov 2010.
- Derived from this study: PubMed 35080771Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.
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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 nail stryker in people with Intertrochanteric Fractures of the Hip, run by Tel-Aviv Sourasky 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 3 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 10 Nov 2010. 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 ortal segal, MD (972-52-60172, ortal_San@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip function 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?
On the ClinicalTrials.gov record for NCT01238068, which also lists 1 linked publication.
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 10 Nov 2010.