NCT04228731

Brief Summary

This is a prospective cohort study comparing standard inpatient (overnight hospital stay) total knee arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be recruited. This study will compare patient satisfaction and costs from the perspectives of the Ministry of Health, the institution, society and the patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

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

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

January 10, 2020

Last Update Submit

March 4, 2025

Conditions

Osteoarthritis, Knee

Keywords

CostTotal Knee ReplacementOutpatient SurgerySatisfactionArthroplasty

Outcome Measures

Primary Outcomes (3)

  • Indirect and direct costs of treatment

    ER visits, clinician visits, caregiver lost productivity, tests, etc.

    1 Year

  • Rate of early complications and adverse events

    fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.

    1 Year

  • Standardized measure of health outcome (EQ-5D)

    utility score measured on a scale of 0 (death) to 1 (perfect health)

    1 Year

Secondary Outcomes (6)

  • Patient satisfaction questionnaire

    2 Weeks

  • Western Ontario McMaster Osteoarthritis Index (WOMAC)

    1 Year

  • Knee Society Score

    1 Year

  • Veterans Rand 12

    1 Year

  • Pain Numeric Rating Scale

    1 Year

  • +1 more secondary outcomes

Study Arms (2)

Outpatient

EXPERIMENTAL

Patients in the outpatient group (same day discharge following TKA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Procedure: Outpatient

Inpatient

ACTIVE COMPARATOR

Patients in the inpatient group (following day discharge following TKA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Procedure: Inpatient

Interventions

OutpatientPROCEDURE

Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty

Outpatient
InpatientPROCEDURE

Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty

Inpatient

Eligibility Criteria

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

You may qualify if:

  • Osteoarthritis of the knee
  • Booked for primary unilateral total knee arthroplasty
  • Have the ability to read and understand English (printed instructions are provided in English only)
  • Home / cell phone access
  • Planning to be discharged to home environment
  • Patient has an adult to accompany them home post-operatively

You may not qualify if:

  • Cognitive issues that preclude the ability to understand instructions or provide informed consent
  • Lack of a social supports at home
  • American Society of Anaesthesiologists (ASA) score equal to or less than 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

Related Publications (9)

  • Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am. 2014 Apr 16;96(8):624-30. doi: 10.2106/JBJS.M.00285.

    PMID: 24740658BACKGROUND

  • Sutton JC 3rd, Antoniou J, Epure LM, Huk OL, Zukor DJ, Bergeron SG. Hospital Discharge within 2 Days Following Total Hip or Knee Arthroplasty Does Not Increase Major-Complication and Readmission Rates. J Bone Joint Surg Am. 2016 Sep 7;98(17):1419-28. doi: 10.2106/JBJS.15.01109.

    PMID: 27605685BACKGROUND

  • Aynardi M, Post Z, Ong A, Orozco F, Sukin DC. Outpatient surgery as a means of cost reduction in total hip arthroplasty: a case-control study. HSS J. 2014 Oct;10(3):252-5. doi: 10.1007/s11420-014-9401-0. Epub 2014 Jul 12.

    PMID: 25264442BACKGROUND

  • Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005 Jun;(435):154-63. doi: 10.1097/01.blo.0000157173.22995.cf.

    PMID: 15930933BACKGROUND

  • Lovald ST, Ong KL, Malkani AL, Lau EC, Schmier JK, Kurtz SM, Manley MT. Complications, mortality, and costs for outpatient and short-stay total knee arthroplasty patients in comparison to standard-stay patients. J Arthroplasty. 2014 Mar;29(3):510-5. doi: 10.1016/j.arth.2013.07.020. Epub 2013 Aug 21.

    PMID: 23972298BACKGROUND

  • Kolisek FR, McGrath MS, Jessup NM, Monesmith EA, Mont MA. Comparison of outpatient versus inpatient total knee arthroplasty. Clin Orthop Relat Res. 2009 Jun;467(6):1438-42. doi: 10.1007/s11999-009-0730-0. Epub 2009 Feb 18.

    PMID: 19224306BACKGROUND

  • Petis SM, Howard JL, Lanting BA, Marsh JD, Vasarhelyi EM. In-Hospital Cost Analysis of Total Hip Arthroplasty: Does Surgical Approach Matter? J Arthroplasty. 2016 Jan;31(1):53-8. doi: 10.1016/j.arth.2015.08.034. Epub 2015 Aug 29.

    PMID: 26387922BACKGROUND

  • The Arthritis Alliance of Canada, The Impact of Arthritis in Canada: Today and over the next 30 Years, 2011 http://www.arthritisalliance.ca/en/initiativesen/impact-of-arthritis

    BACKGROUND

  • Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2017-2018: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2019.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePersonal Satisfaction

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Inosine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Brent Lanting, MD, FRCSC

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

October 22, 2020

Primary Completion

December 22, 2023

Study Completion

February 14, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)