Fracture of Neck of Femur (Hip)NCT05548257
Mortality and Related Risk Factors After Hip Arthroplasty
An observational study of Fracture of Neck of Femur (Hip) and Femoral Head Necrosis, run by RenJi Hospital.
Trial summary
The patients who underwent hip arthroplasty in our hospital from January 2017 to December 2020 were reviewed. The perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Neck of Femur (Hip), Femoral Head Necrosis, Dislocation of Hip Joint
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2022to 4 Aug 2023
- 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: All adult patients undergoing hip arthroplasty in Renji Hospital.
Who may be able to join
- All patients undergoing hip arthroplasty in Renji Hospital during 2017.1-2020.12
Who cannot join
- Patients who did not undergo surgery after admission Age < 18 years Patients undergoing the second operation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mortality and Related Risk Factors After Hip Arthroplasty, a Retrospective Study
The patients who underwent hip arthroplasty in our hospital from January 2017 to December 2020 were reviewed. The perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed.
- Conditions
- Fracture of Neck of Femur (Hip), Femoral Head Necrosis, Dislocation of Hip Joint, Dysplasia of Hip Joint
- Medical subject headings
- Femoral Neck Fractures, Hip Dislocation
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 |
|---|---|---|
| All patients were reviewed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors of mortality one year after operation
Measured: From about even days before operation to 12 months after operation
Secondary outcomes (1)
Risk factors of lower activities of daily living score at 12 months after operation
Measured: From about even days before operation to 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Sep 2022 (estimated)
- Primary completion4 Aug 2023 (estimated)
- Study completion4 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Neck of Femur (Hip)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548257
- Sponsor's protocol ID
- LY2022-012-B
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Related Risk Factors After Hip Arthroplasty, a Retrospective Study
- ClinicalTrials.gov ID
- NCT05548257
- Acronym / sponsor ID
- LY2022-012-B
- Conditions
- Fracture of Neck of Femur (Hip), Femoral Head Necrosis, Dislocation of Hip Joint, Dysplasia of Hip Joint
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (estimated)
- Primary completion
- 4 Aug 2023 (estimated)
- Study completion
- 4 Aug 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
The patients who underwent hip arthroplasty in our hospital from January 2017 to December 2020 were reviewed. The perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients were reviewed | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing hip arthroplasty in Renji Hospital.
Key inclusion criteria (1 listed)
- All patients undergoing hip arthroplasty in Renji Hospital during 2017.1-2020.12
Key exclusion criteria (1 listed)
- Patients who did not undergo surgery after admission Age < 18 years Patients undergoing the second operation
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
Risk factors of mortality one year after operation
Time frame: From about even days before operation to 12 months after operation
1 secondary outcome
Risk factors of lower activities of daily living score at 12 months after operation
Time frame: From about even days before operation to 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Neck of Femur (Hip) and Femoral Head Necrosis, run by RenJi Hospital.
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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leilei WANG, master (8618801966298, wangleilei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of mortality one year after operation (time frame: From about even days before operation to 12 months after operation). 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 21 Sep 2022.