Femoral Neck FracturesNCT00764153
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
A study testing Bipolar hemiarthroplasty and Internal fixation in people with Femoral Neck Fractures, run by Ullevaal University Hospital.
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 and Internal fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Dec 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 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
About this study
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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.
Read the detailed description
Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and 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, Internal fixation
- 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 hemiarthroplastyProcedure or surgery
Also called Charnley/Hastings
Lateral approach. FWB.
Internal fixationProcedure or surgery
Also called Olmed (DePuy)
Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
| Study group | Role | What they receive |
|---|---|---|
| Internal fixation | Other | Closed reduction and internal fixation with two parallel screws (Olmed) Receives: Procedure: Internal fixation |
| Bipolar hemiarthroplasty | Other | Hemiarthroplasty with Charnley/ Hastings prosthesis Receives: Procedure: Bipolar hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: 5-6 years
Secondary outcomes (3)
Eq-5d
Measured: 5-6 years
Barthel Index
Measured: 5-6 years
Reoperations and complications
Measured: 5-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startOct 2002
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Jan Erik Madsen, MD PhD, Study chair, Orthopedic Center, Ulleval University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764153
- Sponsor's protocol ID
- 12-2005-OS-2
- Status last verified
- Oct 2014
- First submitted
- 29 Sep 2008
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frihagen 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 18056740Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.
PubMed 18656868Stoen RO, Lofthus CM, Nordsletten L, Madsen JE, Frihagen F. Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years. Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24.
PubMed 23975250
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
- ClinicalTrials.gov ID
- NCT00764153
- Acronym / sponsor ID
- 12-2005-OS-2
- Conditions
- Femoral Neck Fractures
- Keywords
- Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway
- Study start
- Oct 2002
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Oct 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.
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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.
Detailed description
Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and 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 (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal fixation | Other | Procedure: Internal fixationClosed reduction and internal fixation with two parallel screws (Olmed) |
| Bipolar hemiarthroplasty | Other | Procedure: Bipolar hemiarthroplastyHemiarthroplasty with Charnley/ Hastings prosthesis |
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 hemiarthroplastyAlso: Charnley/HastingsLateral approach. FWB. | Procedure or surgery | Bipolar hemiarthroplasty |
| Internal fixationAlso: Olmed (DePuy)Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed) | Procedure or surgery | Internal fixation |
Primary outcome
Harris Hip Score
Time frame: 5-6 years
3 secondary outcomes
Eq-5d
Time frame: 5-6 years
Barthel Index
Time frame: 5-6 years
Reoperations and complications
Time frame: 5-6 years
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 23 Oct 2014.
- Background: 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.
- Background: PubMed 18656868Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25.
- Background: PubMed 23975250Stoen RO, Lofthus CM, Nordsletten L, Madsen JE, Frihagen F. Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years. Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24.
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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, Oslo, Norway
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar hemiarthroplasty and Internal fixation in people with Femoral Neck Fractures, run by Ullevaal University Hospital.
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 23 Oct 2014. 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?
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 (time frame: 5-6 years). 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 NCT00764153, which also lists 3 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 23 Oct 2014.