Hip FractureCNCNCT00800124
Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures
A study testing cemented Landos prosthesis vs. uncemented Landos prosthesis in people with Hip Fracture, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- cemented Landos prosthesis vs. uncemented Landos prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2005to Jun 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient with Garden 3 or 4 fracture in acute hip fractures.
- Age over 75 years.
Who cannot join
- Patient or relative refuse enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.
Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.
- Conditions
- Hip Fracture
- Being tested
- cemented Landos prosthesis vs. uncemented Landos prosthesis
- Keywords
- hip fracture, hemiprosthesis, bone cement, clinical outcome
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemented Landos prosthesis vs. uncemented Landos prosthesisProcedure or surgery
Also called Titanium prosthesis, Corail uncemented prosthesis
randomization between the cemented and non-cemented prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Cemented hemiprosthesis |
| 2 | Active comparator | Non-cemented hemiprosthesis Receives: Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startJun 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Sykehuset Buskerud HF
- Responsible party
- Sponsor
- Investigators
- Ove Talsnes, MD, Principal investigator, Sykehsuet Innlandet, Elverum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800124
- Sponsor's protocol ID
- CNC2008
- Acronym
- CNC
- Status last verified
- Nov 2008
- First submitted
- 27 Nov 2008
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
- ClinicalTrials.gov ID
- NCT00800124
- Acronym / sponsor ID
- CNC / CNC2008
- Conditions
- Hip Fracture
- Keywords
- hip fracture, hemiprosthesis, bone cement, clinical outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Rikshospitalet University Hospital, Sykehuset Buskerud HF
- Study start
- Jun 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Dec 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.
The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.
Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Cemented hemiprosthesis |
| 2 | Active comparator | Procedure: cemented Landos prosthesis vs. uncemented Landos prosthesisNon-cemented hemiprosthesis |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient with Garden 3 or 4 fracture in acute hip fractures.
- Age over 75 years.
Key exclusion criteria (1 listed)
- Patient or relative refuse enrollment
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 Landos prosthesis vs. uncemented Landos prosthesisAlso: Titanium prosthesis, Corail uncemented prosthesisrandomization between the cemented and non-cemented prosthesis. | Procedure or surgery | 2 |
Primary outcome
Mortality
Time frame: 1 year after surgery
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 24 Nov 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.
Ove Talsnes, MD principal investigator
Sykehsuet Innlandet, Elverum
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 Landos prosthesis vs. uncemented Landos prosthesis in people with Hip Fracture, run by Sykehuset Innlandet HF 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 2 inclusion and 1 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 24 Nov 2014. 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?
Mortality (time frame: 1 year after surgery). 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 Nov 2014.