Knee OsteoarthritisNCT03564730
Staged Versus Simultaneous Bilateral Knee Arthroplasty
A study testing Simultaneous Knee Arthroplasty (UKA) and Staged Knee Arthroplasty (UKA) in people with Knee Osteoarthritis, run by Orthopaedic Innovation Centre at 8 sites in Canada.
Trial 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?" Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Simultaneous Knee Arthroplasty (UKA) and Staged Knee Arthroplasty (UKA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 8 sitesCanada
- Study dates
- 19 Mar 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
University of Calgary
Calgary, Alberta, T2P 3C5
St. Joseph's - McMaster University
Hamilton, Ontario, L8N 4A6
Kingston Health Sciences Center - KGH
Kingston, Ontario, K7L 2V7
London Health Sciences Centre
London, Ontario, N6A 5W9
McGill University
Montreal, Quebec, H3A 0G4
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
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?"
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Simultaneous Knee Arthroplasty (UKA), Staged Knee Arthroplasty (UKA)
- Keywords
- Bilateral, staged, simultaneous
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous Knee Arthroplasty (UKA)Procedure or surgery
Patient will have both knees completed under one anesthetic.
Staged Knee Arthroplasty (UKA)Procedure or surgery
Patient will have knees completed under 2 anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty (TKA) | Active comparator | Patient will have complete replacement - Simultaneous vs Staged Receives: Procedure: Simultaneous Knee Arthroplasty (UKA); Procedure: Staged Knee Arthroplasty (UKA) |
| Unicompartmental Knee Arthroplasty (UKA) | Active comparator | Patient will have half-knee replacement (partial) - Simultaneous vs Staged Receives: Procedure: Simultaneous Knee Arthroplasty (UKA); Procedure: Staged Knee Arthroplasty (UKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Rand 12-item Health Survey Score (VR-12)
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported.
Measured: 1 Year
Secondary outcomes (7)
Joint function (Oxford-12 knee score)
The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option (0-4). A total of the 12 items will indicated the joint function; lower total score = poorer function.
Measured: Pre-operative, 6 months, 12 months, 18 months, 24 months
Return to work
Assessment of ability to return to work and time away from work following surgery.
Measured: Pre-operative, 6 months, 12 months, 18 months, 24 months
Patient satisfaction
Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.
Measured: 6 months, 12 months, 18 months, 24 months
Complications
Evaluation type and frequency of complication (adverse events).
Measured: Intraoperative, 6 months, 12 months, 18 months, 24 months
Hospital stay
Number of days in hospital
Measured: Up to 1 week
Transfusion rate
Number of unit transfused during hospital stay.
Measured: Up to 1 week
Costs of knee replacement surgery
An attempt to calculate costs of surgery using length of stay data to calculate cost between Simultaneous vs Staged procedures. Length of stay will be calculated in days/hours.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start19 Mar 2018
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Innovation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric R. Bohm, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564730
- Sponsor's protocol ID
- B2017-046
- Status last verified
- Feb 2026
- First submitted
- 11 Jun 2018
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03564730
- Acronym / sponsor ID
- B2017-046
- Conditions
- Knee Osteoarthritis
- Keywords
- Bilateral, staged, simultaneous
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Orthopaedic Innovation CentreUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jun 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty (TKA) | Active comparator | Procedure: Simultaneous Knee Arthroplasty (UKA), Procedure: Staged Knee Arthroplasty (UKA)Patient will have complete replacement - Simultaneous vs Staged |
| Unicompartmental Knee Arthroplasty (UKA) | Active comparator | Procedure: Simultaneous Knee Arthroplasty (UKA), Procedure: Staged Knee Arthroplasty (UKA)Patient will have half-knee replacement (partial) - Simultaneous vs Staged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Simultaneous Knee Arthroplasty (UKA)Patient will have both knees completed under one anesthetic. | Procedure or surgery | Total Knee Arthroplasty (TKA), Unicompartmental Knee Arthroplasty (UKA) |
| Staged Knee Arthroplasty (UKA)Patient will have knees completed under 2 anesthetics. | Procedure or surgery | Total Knee Arthroplasty (TKA), Unicompartmental Knee Arthroplasty (UKA) |
Primary outcome
Veterans Rand 12-item Health Survey Score (VR-12)
Time frame: 1 Year
The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported.
7 secondary outcomes
Joint function (Oxford-12 knee score)
Time frame: Pre-operative, 6 months, 12 months, 18 months, 24 months
Return to work
Time frame: Pre-operative, 6 months, 12 months, 18 months, 24 months
Patient satisfaction
Time frame: 6 months, 12 months, 18 months, 24 months
Complications
Time frame: Intraoperative, 6 months, 12 months, 18 months, 24 months
Hospital stay
Time frame: Up to 1 week
Transfusion rate
Time frame: Up to 1 week
Costs of knee replacement surgery
Time frame: Up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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.
Eric R. Bohm, MD principal investigator
University of Manitoba
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Knee Arthroplasty (UKA) and Staged Knee Arthroplasty (UKA) in people with Knee Osteoarthritis, run by Orthopaedic Innovation Centre at 8 sites 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Veterans Rand 12-item Health Survey Score (VR-12) (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2026.