NCT02544620

Brief Summary

The purpose of this study is to evaluate feasibly of outpatient Total Knee Replacement, Total Hip Replacement and Unicompartmental Knee Replacement in a modern fast-track setup. The design is as an observational prospective study, evaluating patients that fulfil discharge criteria on the day of the surgery. The investigators will further evaluate safety aspects, such a early morbidity and mortality, as well as patient satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

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

Study Start

First participant enrolled

September 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

September 6, 2015

Last Update Submit

March 27, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Fulfilment of same day discharge criteria

    On the days of surgery following discharge criteria are continuously evaluated: * \< 500 ml intraoperative blood loss * Back in patient ward \<15.00 * Received instruction from physiotherapist and is safely mobilized * No clinical symptoms of anemia * Pain \<3 while resting, \<5 during exercise. * Spontaneous urination * Post op x-ray is performed and approved * Relatives or friends with patient for \>24 hours * Motivated and accepts same day discharge * Standard discharge criteria fulfilled * Can be discharged before 20.00 If all of the above criteria are fulfilled, the patient can be discharged

    12 hours

Secondary Outcomes (3)

  • Readmissions

    3 months

  • Patient reported satisfaction

    3 months

  • Use of rescue morphine

    7 days

Study Arms (3)

Total Hip arthroplasty

* Unselected primary THA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP)

Other: Does fulfil of discharge criteria on the day of the surgeryOther: Does not fulfil of discharge criteria on the day of the surgery

Total Knee arthroplasty

* Unselected primary TKA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP)

Other: Does fulfil of discharge criteria on the day of the surgeryOther: Does not fulfil of discharge criteria on the day of the surgery

unicompartmental knee arthroplasty

* Unselected primary UKA * American Society of Anesthesiologists (ASA) score I/II * Can be operated as #1 or #2 * No sleep apnea treated with Continuous positive airway pressure (CPAP)

Other: Does fulfil of discharge criteria on the day of the surgeryOther: Does not fulfil of discharge criteria on the day of the surgery

Interventions

Does fulfil of discharge criteria on the day of the surgeryOTHER
Total Hip arthroplastyTotal Knee arthroplastyunicompartmental knee arthroplasty
Does not fulfil of discharge criteria on the day of the surgeryOTHER
Total Hip arthroplastyTotal Knee arthroplastyunicompartmental knee arthroplasty

Eligibility Criteria

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

* Unselected primary THA/TKA/UKA * ASA score I/II * Can be operated as #1 or #2 * No sleep apnea treated with CPAP

You may qualify if:

  • Unselected primary THA/TKA
  • ASA score I/II
  • Can be operated as #1 or #2
  • No sleep apnea treated with CPAP

You may not qualify if:

  • Selected primary THA/TKA
  • ASA score \> 2
  • Cannot be operated as #1 or #2
  • Sleep apnea treated with CPAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

August 31, 2018

Study Completion

December 31, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

DK(1)