Displaced Subcapital Femoral FractureNCT01181037
Bipolar H.A Versus Trochanteric Antegrade Nail for Treatment of Displaced Subcapital Femoral Fractures
An observational study of Displaced Subcapital Femoral Fracture, run by Meir Medical Center at 1 site in Israel.
Trial summary
A retrospective study to compare clinical results of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for displaced femoral subcapital fracture. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Displaced Subcapital Femoral Fracture
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Apr 2012
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients sustained a displaced subcapital femoral fracture and were operated on by colsed reduction and internal fixation with T.A.N nail or Bipolar hemiarthroplasty
Who may be able to join
- Displaced femoral subcapital fracture.
- Active patient.
- Age 40-85.
- Patient was treated by one of the two methods.
Who cannot join
- Age out of range.
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective study to compare clinical results of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for displaced femoral subcapital fracture.
- Conditions
- Displaced Subcapital Femoral Fracture
- Keywords
- Displaced subcapital femoral fracture, Bbipolar H.A., CRIF with Ttrochanteric Antegrade Nail
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 |
|---|---|---|
| 100 patients, displaced subcapital fracture, T.A.N nail. | 100 patients sustained a displaced femoral subcapital fracture, that were operated on with closed reduction and internal fixation with TAN nail. | |
| 100 patients, displaced subcapital fracture, Bipolar H.A.. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
describe treatment of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation
A retrospective study will defer between groups
Measured: 6month to 3 years following operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Displaced Subcapital Femoral FractureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181037
- Sponsor's protocol ID
- mmc10039-2010ctil
- Other IDs
- 0392010
- Status last verified
- Mar 2012
- First submitted
- 2 May 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar H.A Versus Trochanteric Antegrade Nail for Treatment of Displaced Subcapital Femoral Fractures
- ClinicalTrials.gov ID
- NCT01181037
- Acronym / sponsor ID
- mmc10039-2010ctil
- Conditions
- Displaced Subcapital Femoral Fracture
- Keywords
- Displaced subcapital femoral fracture, Bbipolar H.A., CRIF with Ttrochanteric Antegrade Nail
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 13 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.
A retrospective study to compare clinical results of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation with Trochanteric Antegrade Nail for displaced femoral subcapital fracture.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients, displaced subcapital fracture, T.A.N nail. | – | –100 patients sustained a displaced femoral subcapital fracture, that were operated on with closed reduction and internal fixation with TAN nail. |
| 100 patients, displaced subcapital fracture, Bipolar H.A.. | – | – |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients sustained a displaced subcapital femoral fracture and were operated on by colsed reduction and internal fixation with T.A.N nail or Bipolar hemiarthroplasty
Key inclusion criteria (4 listed)
- Displaced femoral subcapital fracture.
- Active patient.
- Age 40-85.
- Patient was treated by one of the two methods.
Key exclusion criteria (1 listed)
- Age out of range.
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
describe treatment of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation
Time frame: 6month to 3 years following operation
A retrospective study will defer between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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?
An observational study of Displaced Subcapital Femoral Fracture, run by Meir 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 4 inclusion and 1 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 19 Mar 2012. 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 yaron brin, MD (0545784734, yaronbrin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe treatment of patients that were treated by Bipolar H.A. vs. closed reduction and internal fixation (time frame: 6month to 3 years following operation). 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 19 Mar 2012.