NCT07834242

Brief Summary

Beneficial and harmful effects of spinal versus general anaesthesia in patients undergoing hip and knee arthroplasty.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
60mo left

Started Oct 2026

Longer than P75 for not_applicable

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

September 7, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

September 29, 2026

Status Verified

August 1, 2026

Enrollment Period

4.9 years

First QC Date

September 7, 2026

Last Update Submit

September 24, 2026

Conditions

Hip ArthroplastyKnee ArthroplastySpinal AnesthesiaGeneral AnesthesiaLength of Hospital StayPatient SatisfactionPostoperative ComplicationsQuality of Recovery (QoR-15)Health-Related Quality-of-Life (EQ-5D-5L)

Outcome Measures

Primary Outcomes (1)

  • Hospital-free days within 30 days

    Defined as the number of days within the first 30 days following hip or knee arthroplasty surgery during which a participant is alive and not admitted to a hospital.

    Postoperative day 0-30

Secondary Outcomes (2)

  • Major complications

    Postoperative day 0-30

  • Quality of Recovery

    24 hours postoperatively

Other Outcomes (5)

  • Patient satisfaction with anaesthesia

    24 hours postoperatively

  • Health-related quality of life (EQ5D5L-VAS)

    Postoperative day 30

  • Number of unplanned hospital-visits

    Postoperative day 0-30

  • +2 more other outcomes

Study Arms (2)

Spinal Anaesthesia

EXPERIMENTAL
Procedure: Spinal anaesthesia

General Anaesthesia

ACTIVE COMPARATOR
Procedure: General anaesthesia

Interventions

Spinal anaesthesiaPROCEDURE

Spinal anaesthesia according to local practice, including optional sedation with sedative-hypnotic pharmacological agents

Spinal Anaesthesia
General anaesthesiaPROCEDURE

General anaesthesia according to local practice

General Anaesthesia

Eligibility Criteria

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

You may qualify if:

  • Scheduled for elective primary elective hip or knee arthroplasty, including unicompartmental knee

You may not qualify if:

  • Scheduled for elective primary hip or knee arthroplasty, including unicompartmental knee
  • Age ≥ 18 years
  • Unable to communicate in written and/or spoken Danish Contraindications against either spinal or general anaesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative ComplicationsPatient Satisfaction

Interventions

Anesthesia, SpinalAnesthesia, General

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Chair Professor

Study Record Dates

First Submitted

September 7, 2026

First Posted

September 22, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

September 29, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Data will be published anonymised in accordance with ICMJE (International Committee of Medical Journal Editors) guidelines.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The study protocol and statistical analysis plan will be available after they have been published.