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Inpatient vs Outpatient Knee Surgery for Osteoarthritis

N/A

Recruiting

Led By Brent Lanting, MD, FRCSC

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Booked for primary unilateral total knee arthroplasty

Osteoarthritis of the knee

Must not have

Cognitive issues that preclude the ability to understand instructions or provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two types of knee surgery in terms of patient satisfaction and cost.

Who is the study for?

This trial is for adults with knee osteoarthritis who are scheduled for primary unilateral total knee replacement, can read and understand English, have a phone, plan to go home after surgery, and have someone to accompany them. It's not for those with cognitive issues or severe health problems (ASA score ≤4).

What is being tested?

The study compares two approaches: standard inpatient total knee replacement requiring an overnight hospital stay versus same-day discharge outpatient surgery. It will evaluate patient satisfaction and the costs involved from various perspectives.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical risks associated with knee replacement surgeries such as pain, swelling, infection risk at the surgical site, blood clots, or complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a first-time knee replacement on one side.

Select...

I have osteoarthritis in my knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I understand instructions and can give informed consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Indirect and direct costs of treatment

Rate of early complications and adverse events

Standardized measure of health outcome (EQ-5D)

Secondary study objectives

Knee Society Score

Oxford Knee Score - English for Canada

Pain Numeric Rating Scale

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OutpatientExperimental Treatment1 Intervention

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).

Group II: InpatientActive Control1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Outpatient

2015

N/A

~1060

0 / 3Eligibility criteria met