Hip FracturesHEMIUNIBIPOLNCT00746876
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.
A study testing Unipolar hip hemiarthroplasty and Bipolar hip hemiarthroplasty in people with Hip Fractures, run by Sykehuset Asker og Baerum at 1 site in Norway.
Trial summary
Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Unipolar hip hemiarthroplasty and Bipolar hip hemiarthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Dec 2015
- 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
- Displaced femoral neck fracture
- 70 years or older
- Ambulatory status: No walking aids
- No mental illness or impaired cognitive function
Who cannot join
- Pathological fracture (malignant disease)
- Ongoing systemic or local infection
- Radiologically presence of acetabular wear (osteoarthrosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.
Read the detailed description
Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.
- Conditions
- Hip Fractures
- Being tested
- Unipolar hip hemiarthroplasty, Bipolar hip hemiarthroplasty
- Keywords
- Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures
- Medical subject headings
- Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unipolar hip hemiarthroplastyDevice
Also called Modular Cathcart Unipolar, DePuy/Johnson and Johnson
Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
Bipolar hip hemiarthroplastyDevice
Also called Celf-Centering Bipolar, DePuy/Johnson and Johnson
Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures
| Study group | Role | What they receive |
|---|---|---|
| Unipolar | Active comparator | 15 patients randomized for treatment with a unipolar hip hemiarthroplasty Receives: Device: Unipolar hip hemiarthroplasty |
| Bipolar | Active comparator | 15 patients randomized for treatment with a bipolar hip hemiarthroplasty Receives: Device: Bipolar hip hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular wear measured with radiostereometry
Measured: 24 months
Secondary outcomes (2)
Harris hip score
Measured: 24 months
Health-related quality of life (eq-5d)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Asker og Baerum
- Sponsor type
- University, hospital or other
- Collaborators
- Ullevaal University Hospital
- Responsible party
- Principal investigator, Wender Figved, Sykehuset Asker og Baerum
- Investigators
- Asbjørn Hjall, M.D., Study director, Asker and Baerum hospital, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746876
- Sponsor's protocol ID
- HEMI-UNI-BIPOL
- Acronym
- HEMIUNIBIPOL
- Status last verified
- Apr 2016
- First submitted
- 3 Sep 2008
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.
- ClinicalTrials.gov ID
- NCT00746876
- Acronym / sponsor ID
- HEMIUNIBIPOL / HEMI-UNI-BIPOL
- Conditions
- Hip Fractures
- Keywords
- Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sykehuset Asker og BaerumUniversity, hospital or other
- Collaborators
- Ullevaal University Hospital
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 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.
Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.
Detailed description
Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unipolar | Active comparator | Device: Unipolar hip hemiarthroplasty15 patients randomized for treatment with a unipolar hip hemiarthroplasty |
| Bipolar | Active comparator | Device: Bipolar hip hemiarthroplasty15 patients randomized for treatment with a bipolar hip hemiarthroplasty |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Displaced femoral neck fracture
- 70 years or older
- Ambulatory status: No walking aids
- No mental illness or impaired cognitive function
Key exclusion criteria (3 listed)
- Pathological fracture (malignant disease)
- Ongoing systemic or local infection
- Radiologically presence of acetabular wear (osteoarthrosis)
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 hip hemiarthroplastyAlso: Modular Cathcart Unipolar, DePuy/Johnson and JohnsonUnipolar hip hemiarthroplasty for the treatment of femoral neck fractures | Device | Unipolar |
| Bipolar hip hemiarthroplastyAlso: Celf-Centering Bipolar, DePuy/Johnson and JohnsonBipolar hip hemiarthroplasty for the treatment of femoral neck fractures | Device | Bipolar |
Primary outcome
Acetabular wear measured with radiostereometry
Time frame: 24 months
2 secondary outcomes
Harris hip score
Time frame: 24 months
Health-related quality of life (eq-5d)
Time frame: 24 months
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 19 Apr 2016.
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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.
Asbjørn Hjall, M.D. study director
Asker and Baerum hospital, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unipolar hip hemiarthroplasty and Bipolar hip hemiarthroplasty in people with Hip Fractures, run by Sykehuset Asker og Baerum 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 4 inclusion and 3 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 19 Apr 2016. 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.
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?
Acetabular wear measured with radiostereometry (time frame: 24 months). 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 Apr 2016.