Hip FracturesNCT02787031

Variations in Anesthesia Care for Hip Fracture Surgery

An observational study of Hip Fractures and Anesthesia, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation. Read more about this study

Who is it for?: Ages 66 years and older
Conditions the study is for: Hip Fractures, Anesthesia, Death
What is being tested?: Neuraxial anesthesia and General anesthesia
Type of treatment: Surgery or procedure
How many people: 107,317 participants
Where: 1 siteCanada
Study dates: Apr 2002to May 2016
Phase: Observational
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 66 years and older
All sexes
No healthy volunteers
Older adult

Study population: All Ontario residents aged 66 years or older on the day of their emergency hip fracture surgery.

Who may be able to join

Had hip fracture surgery
Admitted to hospital on a non-elective basis

Who cannot join

Do not hold a valid provincial health insurance account

Trial locations and contacts

1 site in 1 country.

Canada1 site

Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y4E9

Other trials in Canada

About this study

Official title: Sources of Variation in Anesthesia Care for Hip Fracture Surgery and the Association With Outcomes

The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation.

Read the detailed description

To evaluate the sources of variance in utilization of neuraxial anesthesia the investigators will use multilevel multivariable modeling strategies. This will allow identification of sources of variation (hospital, vs physician, vs patient characteristics), as well as identification of independent predictors of neuraxial use at each of these three levels.

The investigators will also evaluate the independent association of hospital level variation in neuraxial use on our outcomes of interest using multilevel multivariable regression.

Conditions: Hip Fractures, Anesthesia, Death
Being tested: Neuraxial anesthesia, General anesthesia
Keywords: hip fracture, geriatric, epidemiology, practice variation, anesthesia
Medical subject headings: Hip Fractures, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuraxial anesthesiaProcedure or surgery
Also called spinal anesthesia, epidural anesthesia
General anesthesiaProcedure or surgery

Study groups in NCT02787031
Study group	Role	What they receive
Neuraxial anesthesia		Participants in this group will be those who had a spinal or epidural anesthetic without concurrent general anesthesia Receives: Procedure: Neuraxial anesthesia
General anesthesia		Participants in this group will be those who had general anesthesia, including those who had a general plus a concurrent spinal or epidural anesthetic. Receives: Procedure: General anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With All-Cause Mortality at 30-days
Measured: Day of surgery to day of death, or up to 30 days, whichever comes first

Secondary outcomes (1)

Healthcare Costs From the Perspective of the Universal Healthcare System, Using Standardized Methods (Health System Performance Research Network 2013)
Measured: Day of surgery to day of death, or 30 days after surgery, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2002May 2016

First posted1 Jun 2016 (estimated)
Study startApr 2002
Primary completionMar 2013
Study completionMay 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hip FracturesStudies of the same condition, open and under way.
More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
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: 107,317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02787031
Sponsor's protocol ID: DM2
Status last verified: Feb 2025
First submitted: 17 May 2016
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

McIsaac DI, Wijeysundera DN, Bryson GL, Huang A, McCartney CJL, van Walraven C. Hospital-, Anesthesiologist-, and Patient-level Variation in Primary Anesthesia Type for Hip Fracture Surgery: A Population-based Cross-sectional Analysis. Anesthesiology. 2018 Dec;129(6):1121-1131. doi: 10.1097/ALN.0000000000002453.
PubMed 30273269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

All Hip Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sources of Variation in Anesthesia Care for Hip Fracture Surgery and the Association With Outcomes
ClinicalTrials.gov ID: NCT02787031
Acronym / sponsor ID: DM2
Conditions: Hip Fractures, Anesthesia, Death
Keywords: hip fracture, geriatric, epidemiology, practice variation, anesthesia
Study type: Observational
Recruitment status: Completed
Enrolment: 107,317 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: Apr 2002
Primary completion: Mar 2013 (actual)
Study completion: May 2016 (actual)
First posted: 1 Jun 2016 (estimated)
Results: Posted 17 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation.

Detailed description

The investigators will also evaluate the independent association of hospital level variation in neuraxial use on our outcomes of interest using multilevel multivariable regression.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Neuraxial anesthesia	–	Procedure: Neuraxial anesthesiaParticipants in this group will be those who had a spinal or epidural anesthetic without concurrent general anesthesia
General anesthesia	–	Procedure: General anesthesiaParticipants in this group will be those who had general anesthesia, including those who had a general plus a concurrent spinal or epidural anesthetic.

Who may qualify

Ages: 66 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: All Ontario residents aged 66 years or older on the day of their emergency hip fracture surgery.

Key inclusion criteria (2 listed)

Had hip fracture surgery
Admitted to hospital on a non-elective basis

Key exclusion criteria (1 listed)

Do not hold a valid provincial health insurance account

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
Neuraxial anesthesiaAlso: spinal anesthesia, epidural anesthesia	Procedure or surgery	Neuraxial anesthesia
General anesthesia	Procedure or surgery	General anesthesia

Primary outcome

Number of Participants With All-Cause Mortality at 30-days
Time frame: Day of surgery to day of death, or up to 30 days, whichever comes first

1 secondary outcome

Healthcare Costs From the Perspective of the Universal Healthcare System, Using Standardized Methods (Health System Performance Research Network 2013)
Time frame: Day of surgery to day of death, or 30 days after surgery, whichever comes first

Results and safety

Results posted to the registry on 17 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neuraxial Anesthesia	57,080	57,080
General Anesthesia	50,237	50,237

Primary outcome: Number of Participants With All-Cause Mortality at 30-days

Time frame: Day of surgery to day of death, or up to 30 days, whichever comes first. Count of participants. Unit: Participants

Measure	Neuraxial Anesthesia n = 57080	General Anesthesia n = 0
Value	9122	–

Population analysed: Data were not collected from the participants in the "General Anesthesia" Arm/Group. Only neuraxial group data available for all cause 30-day mortality. The aim was to measure the association of hospital-level utilization of neuraxial anesthesia, independent of patient-level use, with 30-day survival and length of stay and costs.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 30 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neuraxial Anesthesia	0 of 0	0 of 0	9,122 of 57,080
General Anesthesia	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Health administrative data are not initially collected for research purposes. There are patient-level predictors, hospital-level variables, and anesthesiologist variables that we could not measure directly. Surgeon-specific variables such as preference for neuraxial versus general anesthesia could influence anesthesia decision making and should be considered. Patient-preference should contribute to warranted variation. The generalizability of our findings to other jurisdictions is uncertain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30273269McIsaac DI, Wijeysundera DN, Bryson GL, Huang A, McCartney CJL, van Walraven C. Hospital-, Anesthesiologist-, and Patient-level Variation in Primary Anesthesia Type for Hip Fracture Surgery: A Population-based Cross-sectional Analysis. Anesthesiology. 2018 Dec;129(6):1121-1131. doi: 10.1097/ALN.0000000000002453.
Individual participant dataSharing planned: Undecided

Related trials for Hip Fractures

Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures

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.

Daniel McIsaac, MD,MPH,FRCPC principal investigator

The Ottawa Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures and Anesthesia, run by Ottawa Hospital Research Institute at 1 site in Canada.

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 17 Mar 2025. 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 Canada. 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 17 Mar 2025). 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?

Number of Participants With All-Cause Mortality at 30-days (time frame: Day of surgery to day of death, or up to 30 days, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02787031, which also lists 1 linked publication.

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 17 Mar 2025.