Hip FracturesNCT02986399
Fast Track Hip Fracture - an Optimized Pathway for Hip Fracture Patients
An observational study of Hip Fractures, run by University Hospital, Akershus.
Trial summary
The study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fast track patient pathway
- How many people
- 2,495 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 14 Sep 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult hip fracture patients operated at Akershus university hospital in 2012, 2013, 2014 and 2015.
Who may be able to join
- Operated at Akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015
- 18 years or older
Who cannot join
- stress fracture
About this study
Official title: Influence of a Fast Track Pathway for Hip Fracture Patients on Mortality and Quality of Life
The study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care.
Read the detailed description
The Norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and American Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4 and 12 months after surgery. Using the unique Norwegian personal identification number the data from the Norwegian hip fracture register will be connected with data from the electronic patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture patients was introduced at the end of 2013. Mortality and quality of life data will be compared for all hip fracture patients operated at AHUS two years before and two years after this change in standard care. The combined data from the register and the electronic patient records will be used for regression analysis.
- Conditions
- Hip Fractures
- Being tested
- Fast track patient pathway
- Keywords
- fast track
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast track patient pathwayOther
Admittance: Ambulance - Radiology - Orthopaedic ward. Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Hip fracture patients operated at Akershus University hospital in 2012 and 2013. | |
| Fast track patient pathway | Hip fracture patients operated at Akershus University hospital in 2014 and 2015. Receives: Other: Fast track patient pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality rate
Percentage of patients who die within 30 days from hip fracture surgery
Measured: Within 30 days from surgery
Secondary outcomes (5)
1 year mortality rate
Percentage of patients who die within 1 year from hip fracture surgery
Measured: Within 1 year from surgery
Quality of life
Quality of life measured by EQ-5D
Measured: 4 and 12 months from surgery
Readmissions
Unscheduled, all-cause readmission within 30 days from discharge from the index admission
Measured: Within 30 days from discharge
Postoperative infection
Superficial and / or deep surgical site infection
Measured: Within 1 year from surgery
Re-operation
All-cause re-operation at the site of the index surgery
Measured: Within 1 year from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start1 Jan 2012
- Primary completion14 Sep 2017
- Study completion14 Sep 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,495 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Asbjorn Aaroen, Professor, Study director, Akershus University Hospital and Faculty of Medicine, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986399
- Sponsor's protocol ID
- 284907
- Status last verified
- Feb 2018
- First submitted
- 6 Dec 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Fast Track Pathway for Hip Fracture Patients on Mortality and Quality of Life
- ClinicalTrials.gov ID
- NCT02986399
- Acronym / sponsor ID
- 284907
- Conditions
- Hip Fractures
- Keywords
- fast track
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,495 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 8 Dec 2016 (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 study examines if the introduction of a fast track pathway for hip fracture patients had an influence on mortality and quality of life by comparing these outcomes between all hip fracture patients operated at Akershus University Hospital two years before and two years after this change in standard care.
Detailed description
The Norwegian hip fracture register prospectively collects data on all hip fracture patients including, among others, time to surgery, type of fracture, type of surgery and American Society of Anesthesiologists (ASA) score. The register also collects quality of life data 4 and 12 months after surgery. Using the unique Norwegian personal identification number the data from the Norwegian hip fracture register will be connected with data from the electronic patient record at Akershus University hospital (AHUS). Fast track surgery for hip fracture patients was introduced at the end of 2013. Mortality and quality of life data will be compared for all hip fracture patients operated at AHUS two years before and two years after this change in standard care. The combined data from the register and the electronic patient records will be used for regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | – | –Hip fracture patients operated at Akershus University hospital in 2012 and 2013. |
| Fast track patient pathway | – | Other: Fast track patient pathwayHip fracture patients operated at Akershus University hospital in 2014 and 2015. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hip fracture patients operated at Akershus university hospital in 2012, 2013, 2014 and 2015.
Key inclusion criteria (2 listed)
- Operated at Akershus university hospital for a hip fracture (neck of femur, trochanteric, subtrochanteric) in 2012, 2013, 2014 or 2015
- 18 years or older
Key exclusion criteria (1 listed)
- stress fracture
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 |
|---|---|---|
| Fast track patient pathwayAdmittance: Ambulance - Radiology - Orthopaedic ward. Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status. | Other | Fast track patient pathway |
Primary outcome
30 day mortality rate
Time frame: Within 30 days from surgery
Percentage of patients who die within 30 days from hip fracture surgery
5 secondary outcomes
1 year mortality rate
Time frame: Within 1 year from surgery
Quality of life
Time frame: 4 and 12 months from surgery
Readmissions
Time frame: Within 30 days from discharge
Postoperative infection
Time frame: Within 1 year from surgery
Re-operation
Time frame: Within 1 year from 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 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Asbjorn Aaroen, Professor study director
Akershus University Hospital and Faculty of Medicine, University of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University Hospital, Akershus.
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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
30 day mortality rate (time frame: Within 30 days from 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 5 Feb 2018.