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One surgery or two? knee replacement study aims to settle debate

NCT ID NCT03564730

Knowledge-focused Sponsor: Orthopaedic Innovation Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares having both knees replaced at the same time versus one after the other in people with knee osteoarthritis. About 224 participants will be randomly assigned to one approach. Researchers will track recovery, joint function, and quality of life to help guide patient and surgeon decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help surgeons and patients decide whether to replace both knees at once or separately, improving recovery planning.
What could go wrong
This is an observational comparison of procedures, not a test of a new treatment. Results may not apply to all patients, and individual risks vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Knee osteoarthritis

Contacts and locations

Locations

  • Concordia Hospital

    Winnipeg, Manitoba, R2K 3S8, Canada

  • Kingston Health Sciences Center - KGH

    Kingston, Ontario, K7L 2V7, Canada

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • McGill University

    Montreal, Quebec, H3A 0G4, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • St. Joseph's - McMaster University

    Hamilton, Ontario, L8N 4A6, Canada

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • University of Calgary

    Calgary, Alberta, T2P 3C5, Canada

More trials for these conditions

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