Hip FracturesHIP COVIDNCT04882670
COVID-19 Pandemic on Health Care and Rehabilitation Outcomes
An observational study of Hip Fractures and Covid19, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Fragility fracture is easily associated with a clinical worsening of patients in terms of quality of life and disability in the medium and long term. Following this traumatic event, more than half of the patients are unable to recover pre-fracture motor skills such as the ability to walk. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Covid19
- How many people
- 360 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2021to 31 Jul 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: hip fracture patients who are admitted to the emergency room of an orthopedic university hospital
Who may be able to join
- Patients diagnosed with fragility hip fracture such as pertrochanteric fracture, femoral neck fracture and subtrochanteric fracture
- Age 65 or older
Who cannot join
- Patients diagnosed with a fragility hip fracture whose nursing record was not scanned at the time of the investigation
- Patients with fragility fractures of the diaphyseal and / or distal femur and acetabular fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of the COVID-19 Pandemic on Health Care and Rehabilitation Outcomes in Frail Patients With a Hip Fracture. A Retrospective Prognostic Study
Fragility fracture is easily associated with a clinical worsening of patients in terms of quality of life and disability in the medium and long term. Following this traumatic event, more than half of the patients are unable to recover pre-fracture motor skills such as the ability to walk. The impact of the COVID-19 pandemic on this type of patient has not been described and it is easy to hypothesize that, given their intrinsic frailty condition, they may have been significantly affected by changes in care pathways.
Read the detailed description
The global health emergency due to the spread of COVID-19 has caused unprecedented pressure on the health systems of the various countries involved. COVID-19 has had a direct impact on the health status of people with an extremely high number of ICU admissions and deaths, but it has also led to a series of equally strong indirect consequences as described in various fields by multiple authors. In order to cope with the great health demand linked to the epidemic, hospitals had to invest human and physical resources, subtracting them from other care activities: operating theaters, surgical and non-surgical departments and the related staff normally destined for patient care were redirected and relocated to the care of COVID patients.
In the field of orthopedic surgery in the first phase of the spread of the epidemic, all non-essential interventions have been postponed and for essential interventions specific paths have been created at hospitals capable of operating even during the pandemic. This organization has led to a reduction in the overall number of hospitalized patients but the number of old patients operated for hip fracture has not decreased. From the point of view of the impact of the COVID-19 pandemic on all patients operated for hip fracture with respect to the care outcomes during the postoperative hospital stay, the available data are lacking.
- Conditions
- Hip Fractures, Covid19
- Medical subject headings
- Hip Fractures, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hip fracture | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pressure ulcer
The lesions were described according to the site of onset and classified by severity categories in accordance with the guide drawn up by the National Pressure Ulcer Advisory Panel - N.P.U.A.P. (NPUAP, EPUAP, \& PPPIA, 2019)
Measured: through hospitalization, an average of 9 days
Secondary outcomes (4)
Incidence of urinary infections
positive urine-culture test report
Measured: through hospitalization, an average of 9 days
Number of accidental falls
The incidence of falls during the hospitalization
Measured: through hospitalization, an average of 9 days
Start day for walking
The first time the patient is able to walk
Measured: through hospitalization, an average of 9 days
Level of independence
ILOA scale, ranged from 0 to 50; 0 is the better level of independence and 50 the worse level of independence.
Measured: 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 Feb 2021
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
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.
- More trials run by Istituto Ortopedico RizzoliThe 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882670
- Sponsor's protocol ID
- 0001531
- Acronym
- HIP COVID
- Status last verified
- Aug 2021
- First submitted
- 16 Feb 2021
- Last updated
- 5 Aug 2021
- 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 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the COVID-19 Pandemic on Health Care and Rehabilitation Outcomes in Frail Patients With a Hip Fracture. A Retrospective Prognostic Study
- ClinicalTrials.gov ID
- NCT04882670
- Acronym / sponsor ID
- HIP COVID / 0001531
- Conditions
- Hip Fractures, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 May 2021 (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.
Fragility fracture is easily associated with a clinical worsening of patients in terms of quality of life and disability in the medium and long term. Following this traumatic event, more than half of the patients are unable to recover pre-fracture motor skills such as the ability to walk. The impact of the COVID-19 pandemic on this type of patient has not been described and it is easy to hypothesize that, given their intrinsic frailty condition, they may have been significantly affected by changes in care pathways.
Detailed description
The global health emergency due to the spread of COVID-19 has caused unprecedented pressure on the health systems of the various countries involved. COVID-19 has had a direct impact on the health status of people with an extremely high number of ICU admissions and deaths, but it has also led to a series of equally strong indirect consequences as described in various fields by multiple authors. In order to cope with the great health demand linked to the epidemic, hospitals had to invest human and physical resources, subtracting them from other care activities: operating theaters, surgical and non-surgical departments and the related staff normally destined for patient care were redirected and relocated to the care of COVID patients.
In the field of orthopedic surgery in the first phase of the spread of the epidemic, all non-essential interventions have been postponed and for essential interventions specific paths have been created at hospitals capable of operating even during the pandemic. This organization has led to a reduction in the overall number of hospitalized patients but the number of old patients operated for hip fracture has not decreased. From the point of view of the impact of the COVID-19 pandemic on all patients operated for hip fracture with respect to the care outcomes during the postoperative hospital stay, the available data are lacking.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hip fracture | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hip fracture patients who are admitted to the emergency room of an orthopedic university hospital
Key inclusion criteria (2 listed)
- Patients diagnosed with fragility hip fracture such as pertrochanteric fracture, femoral neck fracture and subtrochanteric fracture
- Age 65 or older
Key exclusion criteria (2 listed)
- Patients diagnosed with a fragility hip fracture whose nursing record was not scanned at the time of the investigation
- Patients with fragility fractures of the diaphyseal and / or distal femur and acetabular fractures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of pressure ulcer
Time frame: through hospitalization, an average of 9 days
The lesions were described according to the site of onset and classified by severity categories in accordance with the guide drawn up by the National Pressure Ulcer Advisory Panel - N.P.U.A.P. (NPUAP, EPUAP, \& PPPIA, 2019)
4 secondary outcomes
Incidence of urinary infections
Time frame: through hospitalization, an average of 9 days
Number of accidental falls
Time frame: through hospitalization, an average of 9 days
Start day for walking
Time frame: through hospitalization, an average of 9 days
Level of independence
Time frame: 5 days 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 5 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 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 Aug 2021. 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 Italy. 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?
Incidence of pressure ulcer (time frame: through hospitalization, an average of 9 days). 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 Aug 2021.