NCT03984942

Brief Summary

A Quality Study in the use of Post-Anaesthesia Care Unit(PACU) in Hip and Knee Arthroplasty, and the ability to bypass this unit. The investigators wish to investigate the amount of patients who is required to be secondary admitted to the PACU, after primary discharge from the operating room to the surgical ward, thereby bypassing the PACU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

June 11, 2019

Last Update Submit

January 30, 2021

Conditions

SurgeryKnee OsteoarthritisPostoperative ComplicationsHip OsteoarthritisArthroplasty Complications

Keywords

Knee ArthroplastyHip ArthroplastyPostoperative Anaesthesia Care Unit

Outcome Measures

Primary Outcomes (1)

  • Bypassing PACU

    Number of patients in need of secondary relocation to the Post Anaesthesia Care unit after knee and hip arthroplasty.

    Within the first 24 hours.

Secondary Outcomes (5)

  • Postoperative actions and interventions by nurses within 2 hours.

    2 hours after surgery.

  • Postoperative actions and interventions within 24 hours.

    24 hours after surgery.

  • 30 day Follow-up.

    30 days

  • 90 day Follow-up.

    90 days

  • Complications after surgery.

    90 days

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Every patient planned for unilateral Primary Total Hip and Knee Arthroplasty and unilateral unicompartmental knee arthroplasty within a year, or until 600 patients is included.

You may qualify if:

  • Planned elective unilateral primary Hip- og Knee-Arthroplasty and unicompartmental Knee-Arthroplasty.
  • Above 18 years.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital, Capital Region of Denmark.

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, KneePostoperative ComplicationsOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eske Aasvang, Dr.Med.

    Centre for abdominal surgery, rigshospitalet.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2019

First Posted

June 13, 2019

Study Start

October 1, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

DK(1)