Femoral Neck FracturesNCT00749710
Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
A study testing clopidogrel and no antiaggregant therapy in people with Femoral Neck Fractures and Pertrochanteric Fractures, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Neck Fractures, Pertrochanteric Fractures, Antiaggregant Therapy
- What is being tested?
- clopidogrel and no antiaggregant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 60
- pertrochanteric or femoral neck fracture within 48 hours
- clopidogrel treatment - study group
- no antiaggregant treatment - control group
- ASA score <=3
Who cannot join
- hematologic malignancy
- hematologic malfunction
- warfarin treatment
- previous active GI or other internal bleeding - within 1 year
- thrombocytopenia < 150
Trial locations and contacts
No sites are listed yet.
About this study
Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.
Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.
Read more
Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.
No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.
Study hypothesis:
Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.
- Being tested
- clopidogrel, no antiaggregant therapy
- Keywords
- femoral neck fractures, pertrochanteric fractures, antiaggregant therapy, clopidogrel, plavix
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clopidogrelProcedure or surgery
ORIF - surgical treatment
no antiaggregant therapyProcedure or surgery
ORIF - surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | immediate operation - ORIF - of hip fracture in patient treated with clopidogrel Receives: Procedure: clopidogrel |
| 2 | Active comparator | ORIF - surgical treatment patients not on antiaggregant therapy Receives: Procedure: no antiaggregant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications
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 posted9 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (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 Femoral Neck FracturesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Ely Steinberg, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749710
- Sponsor's protocol ID
- TASMC-08-ES-143-CTIL
- Other IDs
- non
- Status last verified
- Sep 2008
- First submitted
- 8 Sep 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. doi: 10.1007/s11914-003-0013-8.
PubMed 16036069
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel
- ClinicalTrials.gov ID
- NCT00749710
- Acronym / sponsor ID
- TASMC-08-ES-143-CTIL
- Keywords
- femoral neck fractures, pertrochanteric fractures, antiaggregant therapy, clopidogrel, plavix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Sep 2008 (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.
Patients suffering from femoral neck or pertrochanteric fractures have a high rate of mortality and morbidity associated mainly with deconditioning and immobilization. Surgical management including open reduction and internaql fixation has been shown to reduce complication and improve outcome in such patients. Delay of surgery produces less optimal results and is associated with higher morbidity even after 24-48 hours of fracture event.
Patients treated with platelet antiaggregants are exposed to higher blood loss during surgery and related complications, as demonstrated in patients treated with Aspirin. However, cessation of antiaggregant therapy before surgery may be associated with complications of a hypercoagulable state and surgery delay.
Clpopidogrel is a fairly new approved antiaggregant drug indicated in cases of failed aspirin treatment in ischemic heart disease and cerebrovascular disease patients as well as in primary prevention of stent restenosis.
No data regarding complications of hip surgery in patients treated with Clpopidogrel is available.
Study hypothesis:
Definitive surgical treatment of patients treated with clopidogrel undergoing open reduction and internal fixation of pertrochnteric and femoral neck fractures is safe although associated with more extensive blood loss during surgery and postoperative wound complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: clopidogrelimmediate operation - ORIF - of hip fracture in patient treated with clopidogrel |
| 2 | Active comparator | Procedure: no antiaggregant therapyORIF - surgical treatment patients not on antiaggregant therapy |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 60
- pertrochanteric or femoral neck fracture within 48 hours
- clopidogrel treatment - study group
- no antiaggregant treatment - control group
- ASA score <=3
Key exclusion criteria (5 listed)
- hematologic malignancy
- hematologic malfunction
- warfarin treatment
- previous active GI or other internal bleeding - within 1 year
- thrombocytopenia < 150
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 |
|---|---|---|
| clopidogrelORIF - surgical treatment | Procedure or surgery | 1 |
| no antiaggregant therapyORIF - surgical treatment | Procedure or surgery | 2 |
Primary outcome
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications
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 9 Sep 2008.
- Background: PubMed 16036069Wehren LE, Magaziner J. Hip fracture: risk factors and outcomes. Curr Osteoporos Rep. 2003 Sep;1(2):78-85. doi: 10.1007/s11914-003-0013-8.
Related trials for Femoral Neck Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
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.
Ely Steinberg, MD principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing clopidogrel and no antiaggregant therapy in people with Femoral Neck Fractures and Pertrochanteric Fractures, run by Tel-Aviv Sourasky Medical Center.
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 5 inclusion and 5 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 9 Sep 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ely Steinberg, MD (972-52-4266346, steinberge@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality 30 days, 1 year functional score 1 year blood loss at surgery blood transfusions during hospitalization wound complications (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 NCT00749710, 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 9 Sep 2008.