Clinical trial NCT03564730: Staged Versus Simultaneous Bilateral Knee Arthroplasty
Official title: Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Bilateral, staged, simultaneous
Lead sponsor: Orthopaedic Innovation Centre
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"

Detailed description: This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs.

This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.

Eligibility criteria: Inclusion Criteria:

* Patients considering bilateral knee arthroplasty
* Patients must sign the consent form
* Patients must be willing to complete the study questionnaires for the duration of the study

Exclusion Criteria:

* Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee
* patients who are unable to complete the questionnaires

Primary outcomes:
measure: Veterans Rand 12-item Health Survey Score (VR-12)
timeFrame: 1 Year
Secondary outcomes:
measure: Joint function (Oxford-12 knee score)
timeFrame: Pre-operative, 6 months, 12 months, 18 months, 24 months
measure: Return to work
timeFrame: Pre-operative, 6 months, 12 months, 18 months, 24 months
measure: Patient satisfaction
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Complications
timeFrame: Intraoperative, 6 months, 12 months, 18 months, 24 months
measure: Hospital stay
timeFrame: Up to 1 week
measure: Transfusion rate
timeFrame: Up to 1 week
measure: Costs of knee replacement surgery
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's - McMaster University
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Center - KGH
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: University of Manitoba
name: Eric R. Bohm, MD
role: PRINCIPAL_INVESTIGATOR
References: