Femoral Neck FractureNCT01114646
Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty
A study testing Cemented Hip Hemiarthroplasty and VerSys Beaded FullCoat, Zimmer in people with Femoral Neck Fracture, run by Hartford Hospital at 1 site in United States.
Trial summary
Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Cemented Hip Hemiarthroplasty and VerSys Beaded FullCoat, Zimmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 55 years
- non-pathologic, displaced subcapital femoral neck fracture
- designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon
- able to ambulate ten feet prior to presentation
Who cannot join
- unable to walk ten feet prior to hip fracture
- multiple extremity trauma
- pathologic fracture of the hip (including malignancy)
- clinically recognized acute myocardial infarction within thirty days prior to enrollment
- previously participated in the trial
- symptoms associated with anemia
- pre-existing metabolic bone disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.
In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.
- Conditions
- Femoral Neck Fracture
- Being tested
- Cemented Hip Hemiarthroplasty, VerSys Beaded FullCoat, Zimmer
- Keywords
- Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture
- 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.
Cemented Hip HemiarthroplastyDevice
The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
VerSys Beaded FullCoat, ZimmerDevice
The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
| Study group | Role | What they receive |
|---|---|---|
| Cemented Hip Hemiarthroplasty | Other | This arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). Receives: Device: Cemented Hip Hemiarthroplasty |
| Press-Fit Hip Hemiarthroplasty | Experimental | This arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), Receives: Device: VerSys Beaded FullCoat, Zimmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Assessment of post-operative mortality at one-year.
Measured: 1 year
Post-Operative Unstable Angina
Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.
Measured: 1 week post-operation
Post-Operative Myocardial Infarction
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
Measured: 1 week post-operation
Secondary outcomes (2)
Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
A modified version of the Older Americans Resources and Services Instrument (OARS) which asks about performance of tasks of daily living during the preceding two weeks.14 These activities include: getting to places, walking distances, shopping for groceries or clothes, preparing meals and doing housecleaning.
Measured: 1 year
Energy/Fatigue Scale
An inquire about fatigue, level of energy and self-efficiency.
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 posted3 May 2010 (estimated)
- Study startMar 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral Neck 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Joseph P. DeAngelis, MD, Study director, Hartford HospitalCourtland G. Lewis, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114646
- Sponsor's protocol ID
- 03001334HU
- Other IDs
- 124013
- Status last verified
- Mar 2013
- First submitted
- 29 Apr 2010
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Status, Morbidity and Mortality in Cemented Versus Uncemented Hemiarthroplasty for Subcapital Hip Fractures: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01114646
- Acronym / sponsor ID
- 03001334HU
- Conditions
- Femoral Neck Fracture
- Keywords
- Hemiarthroplasty, Cemented, Press Fit, Mortality, Morbidity, Functional Status, Displaced femoral neck fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Mar 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 May 2010 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. Currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. This technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). In 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty.
In this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. We propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cemented Hip Hemiarthroplasty | Other | Device: Cemented Hip HemiarthroplastyThis arm received a hemiarthroplasty with a cemented femoral prosthesis (VerSys LD/Fx, Zimmer, Warsaw, IN). |
| Press-Fit Hip Hemiarthroplasty | Experimental | Device: VerSys Beaded FullCoat, ZimmerThis arm received a press-fit hemiarthroplasty (VerSys Beaded FullCoat, Zimmer, Warsaw, IN), |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 55 years
- non-pathologic, displaced subcapital femoral neck fracture
- designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon
- able to ambulate ten feet prior to presentation
Key exclusion criteria (7 listed)
- unable to walk ten feet prior to hip fracture
- multiple extremity trauma
- pathologic fracture of the hip (including malignancy)
- clinically recognized acute myocardial infarction within thirty days prior to enrollment
- previously participated in the trial
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 Hip HemiarthroplastyThe cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN. | Device | Cemented Hip Hemiarthroplasty |
| VerSys Beaded FullCoat, ZimmerThe press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN, | Device | Press-Fit Hip Hemiarthroplasty |
Primary outcome
Mortality
Time frame: 1 year
Assessment of post-operative mortality at one-year.
Post-Operative Unstable Angina
Time frame: 1 week post-operation
Unstable angina was defined as the new onset of prolonged chest pain (greater than or equal to 30 minutes) or two episodes of chest pain thought to be of cardiac origin or an electrocardiogram showing new T-wave inversion, ST depression or elevation with enzymes non-diagnostic of myocardial ischemia.
Post-Operative Myocardial Infarction
Time frame: 1 week post-operation
Myocardial infarction required a positive troponin or electrocardiogram consistent with definite infarction.
2 secondary outcomes
Instrumental Activities of Daily Living (IADL) and Physical Activities of Daily Living (PADL) Scale
Time frame: 1 year
Energy/Fatigue Scale
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph P. DeAngelis, MD study director
Hartford Hospital
Courtland G. Lewis, MD principal investigator
Hartford Hospital
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 Hip Hemiarthroplasty and VerSys Beaded FullCoat, Zimmer in people with Femoral Neck Fracture, run by Hartford Hospital at 1 site in United States.
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 7 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 7 Aug 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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). The study lists 3 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 7 Aug 2018.