SARS-CoV2 InfectionCOLCOVIDNCT04944329
Hip Fracture and COVID-19
An observational study of SARS-CoV2 Infection and Hip Fractures, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- SARS-CoV2 Infection, Hip Fractures, Surgery
- What is being tested?
- Hip fracture surgery
- Type of treatment
- Surgery or procedure
- How many people
- 73,661 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 31 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with hip fracture, and with or without a SARS-COV-2 disease: We included all patients older than 65 years with hip fracture hospitalization recorded between March 1, 2020 and December 31, detected through ICD-10 diagnosis codes , and with a DRG Codes (Diagnosis Related Group) indicating a surgical procedure. Patient with hip fracture hospitalization without a care code indicating a surgical procedure were excluded. Among these patients, we searched for hospitalizations with SARS-CoV2 diagnostic that occurred within 30 days before the date of hospital admission for hip fracture.
Who may be able to join
- Age > 65 yars
- hip fracture hospitalization
- care code indicating a surgical procedure
Who cannot join
- -Patient with hip fracture hospitalization without a care code indicating a surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality.
During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery.
For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.
- Conditions
- SARS-CoV2 Infection, Hip Fractures, Surgery
- Being tested
- Hip fracture surgery
- Medical subject headings
- COVID-19, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip fracture surgeryProcedure or surgery
Hip fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| COLCOVID | adults undergoing hip fracture surgery Receives: Procedure: Hip fracture surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
hospital mortality within 30 days of the date of hospital admission for hip fracture
Measured: Day 0 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 73,661 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Cuvillon, Principal investigator, CHU NIMES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944329
- Sponsor's protocol ID
- LOCAL/2021/PC-02
- Acronym
- COLCOVID
- Status last verified
- Jun 2021
- First submitted
- 26 Jun 2021
- Last updated
- 1 Jul 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Covid-19 Disease and Mortality After Hip Fracture Surgery in Elderly: a Multicentre National French Survey
- ClinicalTrials.gov ID
- NCT04944329
- Acronym / sponsor ID
- COLCOVID / LOCAL/2021/PC-02
- Conditions
- SARS-CoV2 Infection, Hip Fractures, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73,661 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jun 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.
Hip fracture in the elderly is a worldwide public health issue and a medical challenge for early postoperative rehabilitation. More than 2 million people are treated annually with an annual incidence between 100 and 300/100,000 (USA, Europe, China), resulting in a cost of billion dollars and a strain on most surgical facilities. In this context, an early surgical management of patient with fracture within the first 24-48h has been shown to reduce morbidity, length of hospital stay and mortality.
During the Covid-19 pandemics, a higher risk of 30-day mortality has been reported in patients with pre-operative SARS-CoV-2 infection diagnosed 0-2 weeks, 3-4 weeks and 5-6 weeks before surgery compared with patients who did not have a pre-operative SARS-CoV-2 infection. However, this risk seems to disappear in patients diagnosed with SARS-CoV-2 ≥ 7 weeks before surgery. These findings led to propose delayed elective surgery when the benefit-risk ratio was acceptable (cancer, cardiac surgeries). However, delaying surgery in COVID-19 patients (with high risk of immune and thrombotic disorders) with hip fracture could be questionable as the risk related to COVID-19 could be counteracted by the risk delayed surgery.
For assessing the mortality risk related to hip fracture surgery associated with COVID-19, we decided to use the French national hospital discharge records database for comparing the 30-day postoperative mortality in patients with hip fracture and with or without an hospitalization for SARS-COV-2 infection in the 30 previous days before surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COLCOVID | – | Procedure: Hip fracture surgeryadults undergoing hip fracture surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with hip fracture, and with or without a SARS-COV-2 disease: We included all patients older than 65 years with hip fracture hospitalization recorded between March 1, 2020 and December 31, detected through ICD-10 diagnosis codes , and with a DRG Codes (Diagnosis Related Group) indicating a surgical procedure. Patient with hip fracture hospitalization without a care code indicating a surgical procedure were excluded. Among these patients, we searched for hospitalizations with SARS-CoV2 diagnostic that occurred within 30 days before the date of hospital admission for hip fracture.
Key inclusion criteria (3 listed)
- Age > 65 yars
- hip fracture hospitalization
- care code indicating a surgical procedure
Key exclusion criteria (1 listed)
- -Patient with hip fracture hospitalization without a care code indicating a surgical procedure
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 |
|---|---|---|
| Hip fracture surgeryHip fracture surgery | Procedure or surgery | COLCOVID |
Primary outcome
Hospital Mortality
Time frame: Day 0 to Day 30
hospital mortality within 30 days of the date of hospital admission for hip fracture
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 1 Jul 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.
Philippe Cuvillon principal investigator
CHU NIMES
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 SARS-CoV2 Infection and Hip Fractures, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 3 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 1 Jul 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 France. 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?
Hospital Mortality (time frame: Day 0 to Day 30). 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 1 Jul 2021.