Femoral Neck FracturesHEMI-RSADEXANCT00607516
Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
A study testing Cemented primary bipolar hemiarthroplasty of the hip and Uncemented primary bipolar hemiarthroplasty of the hip in people with Femoral Neck Fractures and Bone Density, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Substudy and continuation of HEMI-SAB-UUS (NCT00491673) Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fractures, Bone Density, Acetabular Wear
- What is being tested?
- Cemented primary bipolar hemiarthroplasty of the hip and Uncemented 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
- 22 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2006to Jan 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Femoral neck fracture
- 65 years or older
- Able to walk independently
Who cannot join
- Cognitive dysfunction
- Infection
- Fracture caused by malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
Substudy and continuation of HEMI-SAB-UUS (NCT00491673)
Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.
Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties
Read the detailed description
Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.
- Being tested
- Cemented primary bipolar hemiarthroplasty of the hip, Uncemented primary bipolar hemiarthroplasty of the hip
- Keywords
- fracture, arthroplasty, wear, osteoporosis, bone
- Medical subject headings
- Femoral Neck Fractures, Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented primary bipolar hemiarthroplasty of the hipProcedure or surgery
Also called Spectron, Smith & Nephew, Memphis, TN
Cemented primary bipolar hemiarthroplasty of the hip
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
| Study group | Role | What they receive |
|---|---|---|
| Cemented | Active comparator | Cemented primary bipolar hemiarthroplasty of the hip Receives: Procedure: Cemented primary bipolar hemiarthroplasty of the hip |
| Uncemented | Active comparator | Uncemented primary bipolar hemiarthroplasty of the hip Receives: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular wear in mm
Measured: 1 year
Loss of bone mineral density (BMD)
Measured: 1 year
Secondary outcomes (3)
Functional outcome including pain (Harris Hip Score)
Measured: 1 year
Activities Of Daily Living (Barthels ADL-Index)
Measured: 1 year
Quality Of Life (EQ-5D)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startMar 2006
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lars Nordsletten, Prof MD PhD, Study director, Ullevål University Hospital, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607516
- Sponsor's protocol ID
- HEMI-RSA-DEXA
- Other IDs
- REK I (Norway) 151-05-04061
- Acronym
- HEMI-RSADEXA
- Status last verified
- Feb 2007
- First submitted
- 22 Jan 2008
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT00607516
- Acronym / sponsor ID
- HEMI-RSADEXA / HEMI-RSA-DEXA
- Keywords
- fracture, arthroplasty, wear, osteoporosis, bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 5 Feb 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.
Substudy and continuation of HEMI-SAB-UUS (NCT00491673)
Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.
Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties
Detailed description
Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented | Active comparator | Procedure: Cemented primary bipolar hemiarthroplasty of the hipCemented primary bipolar hemiarthroplasty of the hip |
| Uncemented | Active comparator | Procedure: Uncemented primary bipolar hemiarthroplasty of the hipUncemented primary bipolar hemiarthroplasty of the hip |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Femoral neck fracture
- 65 years or older
- Able to walk independently
Key exclusion criteria (3 listed)
- Cognitive dysfunction
- Infection
- Fracture caused by malignant 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 |
|---|---|---|
| Cemented primary bipolar hemiarthroplasty of the hipAlso: Spectron, Smith & Nephew, Memphis, TNCemented primary bipolar hemiarthroplasty of the hip | Procedure or surgery | Cemented |
| Uncemented primary bipolar hemiarthroplasty of the hipAlso: Corail, DePuy/Johnson and Johnson, United KingdomUncemented primary bipolar hemiarthroplasty of the hip | Procedure or surgery | Uncemented |
Primary outcome
Acetabular wear in mm
Time frame: 1 year
Loss of bone mineral density (BMD)
Time frame: 1 year
3 secondary outcomes
Functional outcome including pain (Harris Hip Score)
Time frame: 1 year
Activities Of Daily Living (Barthels ADL-Index)
Time frame: 1 year
Quality Of Life (EQ-5D)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2009.
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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 director
Ullevål University Hospital, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cemented primary bipolar hemiarthroplasty of the hip and Uncemented primary bipolar hemiarthroplasty of the hip in people with Femoral Neck Fractures and Bone Density, 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 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: status not confirmed, as of the sponsor's last update on 24 Jun 2009. 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?
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?
Acetabular wear in mm (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Jun 2009.