Femoral Neck FracturesHEMI04NCT00491673
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
A study testing Uncemented primary bipolar hemiarthroplasty of the hip and Cemented primary bipolar hemiarthroplasty of the hip in people with Femoral Neck Fractures, run by Ullevaal University Hospital at 2 sites in Norway.
Trial summary
There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly No definite conclusions have been made in regards to what kind of arthroplasty is favourable Cemented implants are associated with increased risk of perioperative cardiovascular… 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?
- Uncemented primary bipolar hemiarthroplasty of the hip and Cemented primary bipolar hemiarthroplasty of the hip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 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
- Dislocated intracapsular femoral neck fracture
- ≥ 70 years old
Who cannot join
- Pathological fracture
- Systemic or local infection
- Short life expectancy/not mobile at all
- Symptomatic coxarthrosis
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ullevål University Hospital
Oslo, Oslo, 0407
Sykehuset Asker And Baerum
Oslo, Rud, 1309
About this study
There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly
No definite conclusions have been made in regards to what kind of arthroplasty is favourable
Read more
Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.
Cementless implants are associated with increased postoperative pain and decreased walking ability.
This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years
Read the detailed description
Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group
Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.
Recorded after surgery:
Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision
Recorded at discharge, 3 months, 1 year and 5 years:
X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids
Publication: International orthopaedic journal.
- Conditions
- Femoral Neck Fractures
- Being tested
- Uncemented primary bipolar hemiarthroplasty of the hip, Cemented primary bipolar hemiarthroplasty of the hip
- Keywords
- Fracture, Femoral neck, Arthroplasty
- Medical subject headings
- Femoral Neck Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented primary bipolar hemiarthroplasty of the hipProcedure or surgery
Also called Corail, DePuy/Johnson and Johnson, United Kingdom
Uncemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hipProcedure or surgery
Also called Spectron, Smith & Nephew, Memphis, TN
Cemented primary bipolar hemiarthroplasty of the hip
| Study group | Role | What they receive |
|---|---|---|
| Uncemented | Active comparator | Uncemented primary bipolar hemiarthroplasty of the hip Receives: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip |
| Cemented | Active comparator | Cemented primary bipolar hemiarthroplasty of the hip Receives: Procedure: Cemented primary bipolar hemiarthroplasty of the hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome including pain (Harris Hip Score)
Measured: 5 years
Secondary outcomes (4)
All Cause Mortality
Measured: 5 years
Activities Of Daily Living (Barthels ADL-Index)
Measured: 5 years
Quality Of Life (EQ-5D)
Measured: 5 years
Any treatment related complication
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startSep 2004
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asker & Baerum Hospital
- Investigators
- Lars Nordsletten, Prof MD PhD, Study chair, Ullevål University Hospital, University of OsloWender Figved, MD, PhD, Principal investigator, Asker and Baerum HospitalLars Nordsletten, Prof MD PhD, Study director, Ullevål University Hospital, University of OsloEllen Langslet, MD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491673
- Sponsor's protocol ID
- HEMI-SAB-UUS
- Acronym
- HEMI04
- Status last verified
- Sep 2010
- First submitted
- 25 Jun 2007
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT00491673
- Acronym / sponsor ID
- HEMI04 / HEMI-SAB-UUS
- Conditions
- Femoral Neck Fractures
- Keywords
- Fracture, Femoral neck, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Asker & Baerum Hospital
- Study start
- Sep 2004
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 26 Jun 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.
There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly
No definite conclusions have been made in regards to what kind of arthroplasty is favourable
Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.
Cementless implants are associated with increased postoperative pain and decreased walking ability.
This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years
Detailed description
Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group
Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.
Recorded after surgery:
Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision
Recorded at discharge, 3 months, 1 year and 5 years:
X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids
Publication: International orthopaedic journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncemented | Active comparator | Procedure: Uncemented primary bipolar hemiarthroplasty of the hipUncemented primary bipolar hemiarthroplasty of the hip |
| Cemented | Active comparator | Procedure: Cemented primary bipolar hemiarthroplasty of the hipCemented primary bipolar hemiarthroplasty of the hip |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Dislocated intracapsular femoral neck fracture
- ≥ 70 years old
Key exclusion criteria (4 listed)
- Pathological fracture
- Systemic or local infection
- Short life expectancy/not mobile at all
- Symptomatic coxarthrosis
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 |
|---|---|---|
| Uncemented primary bipolar hemiarthroplasty of the hipAlso: Corail, DePuy/Johnson and Johnson, United KingdomUncemented primary bipolar hemiarthroplasty of the hip | Procedure or surgery | Uncemented |
| Cemented primary bipolar hemiarthroplasty of the hipAlso: Spectron, Smith & Nephew, Memphis, TNCemented primary bipolar hemiarthroplasty of the hip | Procedure or surgery | Cemented |
Primary outcome
Functional outcome including pain (Harris Hip Score)
Time frame: 5 years
4 secondary outcomes
All Cause Mortality
Time frame: 5 years
Activities Of Daily Living (Barthels ADL-Index)
Time frame: 5 years
Quality Of Life (EQ-5D)
Time frame: 5 years
Any treatment related complication
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
- Pubmed link to publication of 1-year resultsLink provided by the sponsor.
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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.
Lars Nordsletten, Prof MD PhD study chair
Ullevål University Hospital, University of Oslo
Wender Figved, MD, PhD principal investigator
Asker and Baerum Hospital
Lars Nordsletten, Prof MD PhD study director
Ullevål University Hospital, University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented primary bipolar hemiarthroplasty of the hip and Cemented primary bipolar hemiarthroplasty of the hip in people with Femoral Neck Fractures, run by Ullevaal University Hospital at 2 sites 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 2 inclusion and 4 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 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Functional outcome including pain (Harris Hip Score) (time frame: 5 years). 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 24 Sep 2010.