Femoral Neck FracturesPhase 4NCT00464230
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
A Phase 4 study testing Bipolar hemiarthroplasty (Charnley/Hastings) and Internal fixation with two parallel screws (Olmed) in people with Femoral Neck Fractures, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Bipolar hemiarthroplasty (Charnley/Hastings) and Internal fixation with two parallel screws (Olmed)
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2002to Mar 2006
- Phase
- Phase 4
- 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
- Displaced femoral neck fracture
- Age 60 or above
- Able to walk (any aids allowed)
Who cannot join
- Anesthesiologically unfit for arthroplasty surgery
- Previous symptomatic hip pathology (i.e. arthritis)
- Pathological fracture
- Delay of more than 96 hours from injury to treatment
- Not living in hospital area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.
Read the detailed description
We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups:
- Two parallel screws (Olmed).
- Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.
- Conditions
- Femoral Neck Fractures
- Being tested
- Bipolar hemiarthroplasty (Charnley/Hastings), Internal fixation with two parallel screws (Olmed)
- Keywords
- Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living
- Medical subject headings
- Femoral Neck Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar hemiarthroplasty (Charnley/Hastings)Procedure or surgery
Internal fixation with two parallel screws (Olmed)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score at 4, 12 and 24 months
Barthel ADL Index at 4, 12 and 24 months
Eq-5d (Euroqol) at 4, 12 and 24 months
Secondary outcomes (4)
Mortality
Re-operations
Complications
Morbidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startSep 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan Erik Madsen, MD, PhD, Study chair, Orthopedic Center, Ulleval University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464230
- Sponsor's protocol ID
- 12-2005-OS
- Status last verified
- Apr 2007
- First submitted
- 20 Apr 2007
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Waaler Bjornelv GM, Frihagen F, Madsen JE, Nordsletten L, Aas E. Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial. Osteoporos Int. 2012 Jun;23(6):1711-9. doi: 10.1007/s00198-011-1772-1. Epub 2011 Oct 14.
PubMed 21997224Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
PubMed 18056740
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
- ClinicalTrials.gov ID
- NCT00464230
- Acronym / sponsor ID
- 12-2005-OS
- Conditions
- Femoral Neck Fractures
- Keywords
- Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Mar 2006 (actual)
- First posted
- 23 Apr 2007 (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.
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.
Detailed description
We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups:
- Two parallel screws (Olmed).
- Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Displaced femoral neck fracture
- Age 60 or above
- Able to walk (any aids allowed)
Key exclusion criteria (5 listed)
- Anesthesiologically unfit for arthroplasty surgery
- Previous symptomatic hip pathology (i.e. arthritis)
- Pathological fracture
- Delay of more than 96 hours from injury to treatment
- Not living in hospital area
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 |
|---|---|---|
| Bipolar hemiarthroplasty (Charnley/Hastings) | Procedure or surgery | – |
| Internal fixation with two parallel screws (Olmed) | Procedure or surgery | – |
Primary outcome
Harris Hip Score at 4, 12 and 24 months
Barthel ADL Index at 4, 12 and 24 months
Eq-5d (Euroqol) at 4, 12 and 24 months
4 secondary outcomes
Mortality
Re-operations
Complications
Morbidity
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 1 Jul 2011.
- Derived from this study: PubMed 21997224Waaler Bjornelv GM, Frihagen F, Madsen JE, Nordsletten L, Aas E. Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial. Osteoporos Int. 2012 Jun;23(6):1711-9. doi: 10.1007/s00198-011-1772-1. Epub 2011 Oct 14.
- Derived from this study: PubMed 18056740Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
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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.
Jan Erik Madsen, MD, PhD study chair
Orthopedic Center, Ulleval University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bipolar hemiarthroplasty (Charnley/Hastings) and Internal fixation with two parallel screws (Olmed) in people with Femoral Neck Fractures, run by Ullevaal University Hospital at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 1 Jul 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Harris Hip Score at 4, 12 and 24 months. The study lists 3 primary outcomes in all. 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 NCT00464230, which also lists 2 linked publications.
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 1 Jul 2011.