NCT07132723

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 20, 2025

Status Verified

February 1, 2025

Enrollment Period

12 days

First QC Date

February 25, 2025

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post procedure length of stay

    Post procedure length of stay from closed reduction until discharge from the hospital (hours)

    30 days after the closed reduction

Secondary Outcomes (7)

  • All-cause mortality

    90 days after closed reduction

  • Admissions to Intensive care unit

    30 days after the closed reduction

  • Readmission

    30 days after discharge

  • Delirium during admission

    From admission to discharge up to 30 days after closed reduction

  • Acute kidney failure

    Post procedure until 30 days after discharge

  • +2 more secondary outcomes

Study Arms (1)

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

Other: Time in minutes from admission to closed reduction

Interventions

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.

Also known as: - Time of day, - Weekday vs. weekend, - Airway management, - Anesthesia method(s), - Neuromuscular blocking agent (Yes/No)
patients underwent closed reduction of dislocated THA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, North Zeeland Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Interventions

TimeAirway ManagementNeuromuscular Blocking Agents

Intervention Hierarchy (Ancestors)

Physical PhenomenaTherapeuticsNeuromuscular AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Lars H Lundstrøm, MD, PhD

CONTACT

Rikke HF Bjulf, Research fellow

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

August 20, 2025

Study Start

August 20, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-02

Locations