- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228731
Inpatient vs Outpatient Total Knee Replacement
Cost and Patient Satisfaction Associated With Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is a leading cause of disability and reduced quality of life, presenting a substantial, growing burden to patients and the healthcare system (1). Total knee arthroplasty (TKA) is an established, effective interventions for advanced OA. The prevalence of knee OA is rapidly increasing, resulting in a rising demand for care. The number of procedures is expected to grow by 48%, by 2020 in the US (2). Currently, TKA along with total hip arthroplasty (THA), have a significant impact on healthcare budgets, costing approximately $1.2 billion in annual spending in Canada (3). These staggering numbers highlight the critical need to improve care delivery.
A significant proportion of the overall cost of joint replacement results from the inpatient hospital stay following the procedure. Historically, the standard procedure following TKA required an inpatient hospital stay of two and a half to three weeks, however the introduction of less invasive surgical techniques, improved medical and analgesia management and comprehensive rehabilitation have enabled shorter inpatient stays. Today, the median inpatient stay following TKA is three days in Canada (3). A desire for greater autonomy by the patients as well as patients wanting early mobilization to accelerate recovery and return to activities has led some clinicians to consider an outpatient arthroplasty program. The proposed benefits of outpatient arthroplasty include similar patient outcomes with significantly lower hospital costs, and improved patient satisfaction, independence, and autonomy, however there is a lack of high-quality evidence comparing clinical outcomes of outpatient to inpatient arthroplasty models of care.
A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day major complications or readmissions among patients with a zero to two-day hospital stay compared to those discharged on day three or four postoperative (4). Small cohort studies (5-8) suggest lower costs for outpatients and improved patient satisfaction but have inherent biases; limited to carefully selected patients in privatized health systems.
It is estimated that up to 20% of the overall cost of joint replacement can be attributed to the inpatient stay in hospital at our institution (9). By discharging patients as outpatients, it could be possible to save 20% of the overall costs of joint replacement. Although these preliminary calculations are encouraging, it is not sufficient to effect change solely to achieve cost control, without consideration of safety, effectiveness and patient satisfaction. Further, it is unknown whether the financial savings will be outweighed by additional postoperative costs, increased readmissions or decreased quality of care. A full economic evaluation that simultaneously evaluates cost and effectiveness is crucial prior to implementation. The lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial.
The purpose of this study is to evaluate outpatient care pathways for TKA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient TKA.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacquelyn Marsh, PhD
- Phone Number: 88844 519-661-2111
- Email: jmarsh2@uwo.ca
Study Contact Backup
- Name: Dianne Bryant, PhD
- Phone Number: 83947 519-661-2111
- Email: dianne.bryant@uwo.ca
Study Locations
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Ontario
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London, Ontario, Canada, N6A5A5
- Recruiting
- London Health Sciences Centre
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Contact:
- Lyndsay Somerville
- Phone Number: 5196858500
- Email: lyndsay.somerville@lhsc.on.ca
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Outpatient
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).
|
Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty
|
Active Comparator: Inpatient
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).
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Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Indirect and direct costs of treatment
Time Frame: 1 Year
|
ER visits, clinician visits, caregiver lost productivity, tests, etc.
|
1 Year
|
Rate of early complications and adverse events
Time Frame: 1 Year
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fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
|
1 Year
|
Standardized measure of health outcome (EQ-5D)
Time Frame: 1 Year
|
utility score measured on a scale of 0 (death) to 1 (perfect health)
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1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction questionnaire
Time Frame: 2 Weeks
|
patient satisfaction with care pre-, peri- and postoperative
|
2 Weeks
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Western Ontario McMaster Osteoarthritis Index (WOMAC)
Time Frame: 1 Year
|
functional outcome measured on a total scale of 0 (better function) to 100 (worse function) and made up of subscales for pain, stiffness and function
|
1 Year
|
Knee Society Score
Time Frame: 1 Year
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functional outcome measured on a scale of 0 (worse function) to 100 (best function)
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1 Year
|
Pain Numeric Rating Scale
Time Frame: 1 Year
|
pain measured on a scale from 0 (no pain) to 10 (worst pain imaginable)
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1 Year
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Veterans Rand 12
Time Frame: 1 Year
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quality of life measured on a scale of 0 (worse) to 100 (better) using norm-based scoring
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1 Year
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Oxford Knee Score - English for Canada
Time Frame: 1 Year
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Level of function, activities of daily living, and effects of pain over preceding four weeks, measured with 12 questions each on a scale from 0 (worst outcome) to 4 (best outcome).
A higher score represents a better outcome, with total score range from 1-48.
|
1 Year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brent Lanting, MD, FRCSC, London Health Sciences Centre
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2017-2018: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2019.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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