Closed ReductionNCT07132723
Associations Between Time to Reduction and Complications in Patients With Dislocated Total Hip Arthroplasty
An observational study of Closed Reduction and Arthroplasty, Replacement, Hip, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the impact of time to closed reduction on both patient related and organizational factors. These include, length of stay, hospitalization, admission to intensive care unit, rehospitalizations, delirium, all-cause mortality, infection requiring hospital contact, and cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Reduction, Arthroplasty, Replacement, Hip, Length of Stay
- What is being tested?
- Time in minutes from admission to closed reduction
- How many people
- 3,700 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The cohort contains all adults presenting with a dislocated THA, who underwent closed reduction in an operating theatre with anesthesiology being involved, in public hospitals in the Capital and Zealand Regions of Denmark. The study population is extracted from a dataset retrieved from the Electronic Health Record (EHR) system 'Sundhedsplatformen' (Epic Systems Corporation, WI, USA) from 1 January 2017 to 31 December 2024, including granular data from approximately 1.1 million anesthetic procedures
Who may be able to join
- Patients will be considered eligible for inclusion if they meet all of the following criteria:
- Aged 18 years or older
- Presented to the emergency department with a dislocated total hip arthroplasty.
- Undergo closed reduction of the dislocated total hip arthroplasty in the operating theatre, with the involvement of the Department of Anesthesiology.
Who cannot join
- Were primarily booked for open surgical reduction.
- Did not have a complete case log (i.e. time of admission; referral to the operation theatre; anesthesia induction; discharge, etc.) and we were unable to recreate the log using simple code rules.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rikke HF Bjulf, Research fellow contact
Denmark1 site
Department of Anesthesiology, North Zeeland Hospital
Hillerød, 3400
Lars Lundstrøm, +4548296512, lars.hyldborg.lundstroem.02@regionh.dk
Rikke HF Bjulf, Research Fellow
About this study
Official title: Associations Between Time to Reduction and Complications in Patients With Dislocated Total Hip Arthroplasty - A Protocol for an Observational Cohort Study
The aim of the study is to investigate the impact of time to closed reduction on both patient related and organizational factors. These include, length of stay, hospitalization, admission to intensive care unit, rehospitalizations, delirium, all-cause mortality, infection requiring hospital contact, and cardiovascular complications. It is also intended to investigate whether different anaesthetic strategies and airway management are associated with different complication rates.
It is hypothesized that longer waiting time until reduction increase the postoperative length of stay, readmissions, and risk of complications.
- Being tested
- Time in minutes from admission to closed reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time in minutes from admission to closed reductionOther
Also called - Time of day, - Weekday vs. weekend, - Airway management, - Anesthesia method(s)
Time in minutes from admission to closed reduction measured as: From arriving time in the emergency department until the start of surgery in the operating theater.
| Study group | Role | What they receive |
|---|---|---|
| patients underwent closed reduction of dislocated THA | adults presenting with a dislocated THA, who underwent closed reduction in an operating theatre with anesthesiology being involved, in public hospitals Receives: Other: Time in minutes from admission to closed reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post procedure length of stay
Post procedure length of stay from closed reduction until discharge from the hospital (hours)
Measured: 30 days after the closed reduction
Secondary outcomes (7)
All-cause mortality
90 days all-cause mortality (Y/N)
Measured: 90 days after closed reduction
Admissions to Intensive care unit
Admissions to the intensive care unit within 30 days after the closed reduction.
Measured: 30 days after the closed reduction
Readmission
Readmission within 30 days after discharge
Measured: 30 days after discharge
Delirium during admission
Defined as diagnose of delirium (F05.x, obtained from the diagnosis codes from the given admission) or the non-planned administration of haloperidol, olanzapine, risperidone, or quetiapine (as a surrogate for new onset delirium)
Measured: From admission to discharge up to 30 days after closed reduction
Acute kidney failure
Defined as serum creatinine increase of more than 25 μmol/L within a period of less than 48 hours. (As a surrogate for acute kidney failure)
Measured: Post procedure until 30 days after discharge
Infection requiring hospital contact
Defined as diagnosed infection (postoperative infection (T81.4), pneumonia (J13.x-J18.x), Cystitis (N30.x, N39.0), sepsis (R65.x A40.x, A41.x), C. difficile (A04.7) obtained from the diagnose codes from the given admission) or administration of antibiotic treatment (as a surrogate for in-hospital infection
Measured: Post procedure until 30 days after discharge
Cardiovascular complications
Defined as diagnosed arrythmia (I47.x, I48.x, I49.x), myocardial infarction (I21.x, I22.x), cerebral ischemia (I61.x, I63.x, I64.x), hemorrhage(T81), pulmonary embolism(I26.x) or deep venous thrombosis(I80.2) (obtained from the diagnosis codes from the given admission)
Measured: From admission to 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed ReductionStudies 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
- Retrospective
- Enrolment
- 3,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132723
- Sponsor's protocol ID
- HIP_REDUCTION
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Time to Reduction and Complications in Patients With Dislocated Total Hip Arthroplasty - A Protocol for an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07132723
- Acronym / sponsor ID
- HIP_REDUCTION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,700 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 20 Aug 2025 (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 aim of the study is to investigate the impact of time to closed reduction on both patient related and organizational factors. These include, length of stay, hospitalization, admission to intensive care unit, rehospitalizations, delirium, all-cause mortality, infection requiring hospital contact, and cardiovascular complications. It is also intended to investigate whether different anaesthetic strategies and airway management are associated with different complication rates.
It is hypothesized that longer waiting time until reduction increase the postoperative length of stay, readmissions, and risk of complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients underwent closed reduction of dislocated THA | – | Other: Time in minutes from admission to closed reductionadults presenting with a dislocated THA, who underwent closed reduction in an operating theatre with anesthesiology being involved, in public hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort contains all adults presenting with a dislocated THA, who underwent closed reduction in an operating theatre with anesthesiology being involved, in public hospitals in the Capital and Zealand Regions of Denmark. The study population is extracted from a dataset retrieved from the Electronic Health Record (EHR) system 'Sundhedsplatformen' (Epic Systems Corporation, WI, USA) from 1 January 2017 to 31 December 2024, including granular data from approximately 1.1 million anesthetic procedures
Key inclusion criteria (4 listed)
- Patients will be considered eligible for inclusion if they meet all of the following criteria:
- Aged 18 years or older
- Presented to the emergency department with a dislocated total hip arthroplasty.
- Undergo closed reduction of the dislocated total hip arthroplasty in the operating theatre, with the involvement of the Department of Anesthesiology.
Key exclusion criteria (2 listed)
- Were primarily booked for open surgical reduction.
- Did not have a complete case log (i.e. time of admission; referral to the operation theatre; anesthesia induction; discharge, etc.) and we were unable to recreate the log using simple code rules.
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 |
|---|---|---|
| Time in minutes from admission to closed reductionAlso: - Time of day, - Weekday vs. weekend, - Airway management, - Anesthesia method(s)Time in minutes from admission to closed reduction measured as: From arriving time in the emergency department until the start of surgery in the operating theater. | Other | patients underwent closed reduction of dislocated THA |
Primary outcome
Post procedure length of stay
Time frame: 30 days after the closed reduction
Post procedure length of stay from closed reduction until discharge from the hospital (hours)
7 secondary outcomes
All-cause mortality
Time frame: 90 days after closed reduction
Admissions to Intensive care unit
Time frame: 30 days after the closed reduction
Readmission
Time frame: 30 days after discharge
Delirium during admission
Time frame: From admission to discharge up to 30 days after closed reduction
Acute kidney failure
Time frame: Post procedure until 30 days after discharge
Infection requiring hospital contact
Time frame: Post procedure until 30 days after discharge
Cardiovascular complications
Time frame: From admission to 30 days after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Rikke HF Bjulf, Research fellow contact
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 Closed Reduction and Arthroplasty, Replacement, Hip, run by Nordsjaellands Hospital at 1 site in Denmark.
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 4 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: opening soon, as of the sponsor's last update on 20 Aug 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars H Lundstrøm, MD, PhD (+4548296512, lars.hyldborg.lundstroem.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post procedure length of stay (time frame: 30 days after the closed reduction). 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 20 Aug 2025.