Osteoarthritis, KneeNCT04228731
Inpatient vs Outpatient Total Knee Replacement
A study testing Outpatient and Inpatient in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Outpatient and Inpatient
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2020to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cost and Patient Satisfaction Associated With Total Knee Arthroplasty
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Outpatient, Inpatient
- Keywords
- Cost, Total Knee Replacement, Outpatient Surgery, Satisfaction, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientProcedure or surgery
Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty
InpatientProcedure or surgery
Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indirect and direct costs of treatment
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Measured: 1 Year
Rate of early complications and adverse events
fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Measured: 1 Year
Standardized measure of health outcome (EQ-5D)
utility score measured on a scale of 0 (death) to 1 (perfect health)
Measured: 1 Year
Secondary outcomes (6)
Patient satisfaction questionnaire
patient satisfaction with care pre-, peri- and postoperative
Measured: 2 Weeks
Western Ontario McMaster Osteoarthritis Index (WOMAC)
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
Measured: 1 Year
Knee Society Score
functional outcome measured on a scale of 0 (worse function) to 100 (best function)
Measured: 1 Year
Veterans Rand 12
quality of life measured on a scale of 0 (worse) to 100 (better) using norm-based scoring
Measured: 1 Year
Pain Numeric Rating Scale
pain measured on a scale from 0 (no pain) to 10 (worst pain imaginable)
Measured: 1 Year
Oxford Knee Score - English for Canada
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start22 Oct 2020
- Primary completion22 Dec 2023
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brent Lanting, MD, FRCSC, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228731
- Sponsor's protocol ID
- 115081
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2020
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24740658Sutton 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.
PubMed 27605685Aynardi 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.
PubMed 25264442Bertin 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.
PubMed 15930933Lovald 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.
PubMed 23972298Kolisek 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.
PubMed 19224306Petis 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.
PubMed 26387922The 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 at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost and Patient Satisfaction Associated With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04228731
- Acronym / sponsor ID
- 115081
- Conditions
- Osteoarthritis, Knee
- Keywords
- Cost, Total Knee Replacement, Outpatient Surgery, Satisfaction, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Experimental | Procedure: OutpatientPatients 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). |
| Inpatient | Active comparator | Procedure: InpatientPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutpatientPatients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty | Procedure or surgery | Outpatient |
| InpatientPatients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty | Procedure or surgery | Inpatient |
Primary outcome
Indirect and direct costs of treatment
Time frame: 1 Year
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Rate of early complications and adverse events
Time frame: 1 Year
fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Standardized measure of health outcome (EQ-5D)
Time frame: 1 Year
utility score measured on a scale of 0 (death) to 1 (perfect health)
6 secondary outcomes
Patient satisfaction questionnaire
Time frame: 2 Weeks
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Time frame: 1 Year
Knee Society Score
Time frame: 1 Year
Veterans Rand 12
Time frame: 1 Year
Pain Numeric Rating Scale
Time frame: 1 Year
Oxford Knee Score - English for Canada
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 24740658Kurtz 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.
- Background: PubMed 27605685Sutton 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.
- Background: PubMed 25264442Aynardi 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.
- Background: PubMed 15930933Bertin 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.
- Background: PubMed 23972298Lovald 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.
- Background: PubMed 19224306Kolisek 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.
- Background: PubMed 26387922Petis 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.
- BackgroundThe 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
- BackgroundCanadian Institute for Health Information. Hip and Knee Replacements in Canada, 2017-2018: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Lanting, MD, FRCSC principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient and Inpatient in people with Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indirect and direct costs of treatment (time frame: 1 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228731, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.