Femoral Neck FracturesNCT00317837
Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture
A study testing Unipolar Hemiarthroplasty of the hip joint and bipolar hemiarthroplasty in people with Femoral Neck Fractures, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.
Trial summary
Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Unipolar Hemiarthroplasty of the hip joint and bipolar hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesDenmark
- Study dates
- Oct 2004to Dec 2010
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ages 70 years or above
- Dislocated medial femoral neck fracture (garden type 3-4)
- Residence in the county of Northern Jutland, Denmark
Who cannot join
- Pathologic fracture
- Failed formerly internally fixed fracture of the affected hip
- Degenerative joint disease of the affected hip or rheumatoid arthritis
- Dementia
- Terminal neoplastic disease
- No informed consent
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland
Northern Orthopaedic Division, Klinik Farsoe
Farsø, Northern Jutland
Northern Orthopaedic Division, Klinik Hjoerring
Hjørring, Northern Jutland
About this study
Official title: Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture
Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.
- Conditions
- Femoral Neck Fractures
- Being tested
- Unipolar Hemiarthroplasty of the hip joint, bipolar hemiarthroplasty
- Keywords
- Fracture of Femoral Neck
- 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.
Unipolar Hemiarthroplasty of the hip jointProcedure or surgery
Unipolar Hemiarthroplasty of the hip joint
bipolar hemiarthroplastyProcedure or surgery
bipolar hemiarthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients treated with a cemented modular hemiarthroplasty, with a unipolar head Receives: Procedure: Unipolar Hemiarthroplasty of the hip joint |
| 2 | Active comparator | Patients treated with a modular cemented hemiarthroplasty with a bipolar head. Receives: Procedure: bipolar hemiarthroplasty |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startOct 2004
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Recruitment was too slow, primary investigator has left the organisation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Lamm, MD, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317837
- Sponsor's protocol ID
- ON-04-005-LAM
- Status last verified
- Mar 2014
- First submitted
- 23 Apr 2006
- Last updated
- 31 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT00317837
- Acronym / sponsor ID
- ON-04-005-LAM
- Conditions
- Femoral Neck Fractures
- Keywords
- Fracture of Femoral Neck
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment was too slow, primary investigator has left the organisation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 25 Apr 2006 (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.
Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Unipolar Hemiarthroplasty of the hip jointPatients treated with a cemented modular hemiarthroplasty, with a unipolar head |
| 2 | Active comparator | Procedure: bipolar hemiarthroplastyPatients treated with a modular cemented hemiarthroplasty with a bipolar head. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients ages 70 years or above
- Dislocated medial femoral neck fracture (garden type 3-4)
- Residence in the county of Northern Jutland, Denmark
Key exclusion criteria (6 listed)
- Pathologic fracture
- Failed formerly internally fixed fracture of the affected hip
- Degenerative joint disease of the affected hip or rheumatoid arthritis
- Dementia
- Terminal neoplastic disease
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 |
|---|---|---|
| Unipolar Hemiarthroplasty of the hip jointUnipolar Hemiarthroplasty of the hip joint | Procedure or surgery | 1 |
| bipolar hemiarthroplastybipolar hemiarthroplasty | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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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.
Martin Lamm, MD principal investigator
Northern Orthopaedic Division
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar Hemiarthroplasty of the hip joint and bipolar hemiarthroplasty in people with Femoral Neck Fractures, run by Northern Orthopaedic Division, Denmark at 3 sites in Denmark.
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 6 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: withdrawn, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 31 Mar 2014.