Hip FracturesNCT03265275
Why Still in Hospital After Hip Fracture Surgery?
An observational study of Hip Fractures, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
At our institution, hip fracture patients are admitted and treated according to a fast track patient pathway. The aim of this study is to identify areas of this patient pathway that can be improved. 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
- Type of treatment
- Injection or infusion
- How many people
- 182 participants
- Where
- 1 siteNorway
- Study dates
- 11 Sep 2017to 31 Mar 2020
- 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: Patients over 18 years of age, who have been operated for a hip fracture at the orthopedic department, Akershus University Hospital.
Who may be able to join
- Operated at the orthopedic department, Akershus University Hospital, for a hip fracture
Who cannot join
- Lack of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
At our institution, hip fracture patients are admitted and treated according to a fast track patient pathway. The aim of this study is to identify areas of this patient pathway that can be improved. To achieve this, the study will investigate the underlying reasons for the continued need for hospitalization on the consecutive days after hip fracture surgery.
Read the detailed description
The study will be conducted at the orthopedic department, Akershus University Hospital, as a prospective observational study and will include approximately 200 consecutive hip fracture patients. The patients will be evaluated once daily for the fulfillment of predefined discharge criteria. If the discharge criteria are not met or if the criteria are met but the patient is not discharged in spite of this the underlying reason(s) are recorded.
- 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
Prehospital services establish a working diagnosis of hip fracture and initiate first line treatment. In the emergency department a specially trained nurse triages the patient. Patients without signs of other acute disease or trauma and who have not previously been operated in the same hip are directly transported to the x-ray suite. The x-rays are reviewed by the radiographer and in case of an obvious fracture of the hip the patient is transported directly to the orthopedic ward where the patient is received by a nurse and seen by an orthopedic surgeon. The pathway includes standard procedures for blood sampling, pain relief, including a fascia iliaca compartment block, intravenous fluids, transfusion triggers, management of anticoagulants and premedication. The pathway puts focus on prevention of pressure sores, a short preoperative fasting period and early mobilization. Screening tools are used to assess for delirium, nutritional status and fall risk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors necessitating hospitalization after hip fracture surgery
Recorded as: acute anemia, delirium, medical complications, pain, dizziness, nausea/vomiting, logistical reasons, unwillingness to be discharged, other (specified as free text)
Measured: Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture surgery
Secondary outcomes (2)
Percentage of patients discharged to their preoperative level of care
Measured: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
Length of hospital stay
Length of hospital stay in days, stratified after type of operation
Measured: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start11 Sep 2017
- Primary completion28 Feb 2020
- Study completion31 Mar 2020
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
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Asbjorn Aaroen, Professor, Study director, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265275
- Sponsor's protocol ID
- 2017/CP
- Status last verified
- Nov 2020
- First submitted
- 23 Aug 2017
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Still in Hospital After Hip Fracture Surgery?
- ClinicalTrials.gov ID
- NCT03265275
- Acronym / sponsor ID
- 2017/CP
- Conditions
- Hip Fractures
- Keywords
- Fast track
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
At our institution, hip fracture patients are admitted and treated according to a fast track patient pathway. The aim of this study is to identify areas of this patient pathway that can be improved. To achieve this, the study will investigate the underlying reasons for the continued need for hospitalization on the consecutive days after hip fracture surgery.
Detailed description
The study will be conducted at the orthopedic department, Akershus University Hospital, as a prospective observational study and will include approximately 200 consecutive hip fracture patients. The patients will be evaluated once daily for the fulfillment of predefined discharge criteria. If the discharge criteria are not met or if the criteria are met but the patient is not discharged in spite of this the underlying reason(s) are recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age, who have been operated for a hip fracture at the orthopedic department, Akershus University Hospital.
Key inclusion criteria (1 listed)
- Operated at the orthopedic department, Akershus University Hospital, for a hip fracture
Key exclusion criteria (1 listed)
- Lack of written informed consent
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 pathwayPrehospital services establish a working diagnosis of hip fracture and initiate first line treatment. In the emergency department a specially trained nurse triages the patient. Patients without signs of other acute disease or trauma and who have not previously been operated in the same hip are directly transported to the x-ray suite. The x-rays are reviewed by the radiographer and in case of an obvious fracture of the hip the patient is transported directly to the orthopedic ward where the patient is received by a nurse and seen by an orthopedic surgeon. The pathway includes standard procedures for blood sampling, pain relief, including a fascia iliaca compartment block, intravenous fluids, transfusion triggers, management of anticoagulants and premedication. The pathway puts focus on prevention of pressure sores, a short preoperative fasting period and early mobilization. Screening tools are used to assess for delirium, nutritional status and fall risk. | Other | – |
Primary outcome
Factors necessitating hospitalization after hip fracture surgery
Time frame: Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture surgery
Recorded as: acute anemia, delirium, medical complications, pain, dizziness, nausea/vomiting, logistical reasons, unwillingness to be discharged, other (specified as free text)
2 secondary outcomes
Percentage of patients discharged to their preoperative level of care
Time frame: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
Length of hospital stay
Time frame: At hospital discharge, typically between 1 to 14 days after hip fracture 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 30 Nov 2020.
- 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
University Hospital, Akershus
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, run by University Hospital, Akershus 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 1 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 30 Nov 2020. 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?
Factors necessitating hospitalization after hip fracture surgery (time frame: Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture 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 30 Nov 2020.