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Osteoarthritis, KneeNCT03457051

Unicompartmental Knee Arthroplasty (UKA) Versus Total Knee Arthroplasty (TKA) of Medial Osteoarthritis

A study testing Total Knee Arthroplasty (TKA) and Unicompartmental Knee Arthroplasty (UKA) in people with Osteoarthritis, Knee, run by Ottawa Hospital Research Institute at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study allows patients to take part of the decision making between a unicompartment knee (partial ) or a total Knee replacement . Using the measures of a decision aid questionnaire which explicitly details the risks and benefits of both procedures.The study will use subjective (reported by patient) and objective… Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Total Knee Arthroplasty (TKA) and Unicompartmental Knee Arthroplasty (UKA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2021to Sep 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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Those with inflammatory arthritis
  • Those with no fixed address
  • Those unable to commit to study requirements and follow-ups

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: A Randomized Trial Comparing Outcomes of Unicompartmental and Total Knee Replacement for Isolated Medial Osteoarthritis: A Feasibility Study

This study allows patients to take part of the decision making between a unicompartment knee (partial ) or a total Knee replacement . Using the measures of a decision aid questionnaire which explicitly details the risks and benefits of both procedures.The study will use subjective (reported by patient) and objective data (which will be measured) to allow the determination if one option is superior to the other. Information gathered from this study will be used to assist future patients in selecting the surgical option that best fits their life style.

A feasibility pilot study of a randomized clinical trial will help to evaluate the outcomes of both procedures and help shape a multicentre Canadian study.

Read the detailed description

Osteoarthritis of the knee is an increasingly common problem for many Canadians aged 50 or greater. When conservative management fails, patients are often offered a type of knee replacement as treatment. The choices are a total knee replacement or a partial knee replacement, which carry distinct advantages and disadvantages. Typically, patients with partial knee replacement have less post operative pain, quicker recovery and enhanced function with greater knee bend. There is however a higher chance of revision where the pain is not relieved or the implant fails. The decision for which replacement to offer is now primarily surgeon driven, shaped by their experience, review of evidence and capability to perform either of these options. Canadian patients would benefit from a decision making model so their own values can shape and determine the decision. This research hopes to evaluate the merits of a patient based decision aid which explicitly details the risks and benefits of both procedures as they are best understood today. Further, the quality of the current evidence is only moderately strong limited by patient selection biases and there is a need for contemporary comparative study trial of the 2 procedures to help clinicians and patients make the decision.

A feasibility pilot study of a randomized clinical trial is being proposed to evaluate the outcomes of both procedures, which will help shape a multicentre Canadian study.

Being tested
Total Knee Arthroplasty (TKA), Unicompartmental Knee Arthroplasty (UKA)
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee Arthroplasty (TKA)Procedure or surgery

    In total (complete) knee arthroplasty (TKA), the orthopaedic surgeon removes the damaged areas of the knee and replaces the components with an artificial joint. The device that will be used is: Stryker TKA Triathlon system implant Cruciate retaining radius femur design. This device has been approved for use by Health Canada.

  • Unicompartmental Knee Arthroplasty (UKA)Procedure or surgery

    Unicompartment (partial) knee arthroplasty (UKA) has been available for over 40 years and differs from TKA in that only the most affected and symptomatic compartment (most commonly medial, but occasionally lateral and patella femoral) are replaced. The device that will be used is: Stryker PKR implant cemented and fixed bearing design. This device has been approved for use by Health Canada.

Study groups in NCT03457051
Study groupRoleWhat they receive
Total Knee Arthroplasty (TKA)Active comparatorIn total (complete) knee arthroplasty (TKA), the orthopaedic surgeon removes the damaged areas of the knee and replaces the components with an artificial joint that is made of plastic or metal.
Receives: Procedure: Total Knee Arthroplasty (TKA)
Unicompartmental Knee Arthroplasty (UKA)ExperimentalUnicompartment (partial) knee arthroplasty (UKA) has been available for over 40 years and differs from TKA in that only the most affected and symptomatic compartment (most commonly medial, but occasionally lateral and patella femoral) are replaced
Receives: Procedure: Unicompartmental Knee Arthroplasty (UKA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. All the items are scored on a scale of 0-4; lower scores are indicative of lower disease burden. Values are summed for a combined WOMAC score (Total score ranges from 0-96, with higher scores indicating worse pain, stiffness, and functional limitations).

    Measured: 36 months

Secondary outcomes (5)

  1. Change in Oxford Knee Score (OKS)

    Patient-reported questionnaire. The sum of the questionnaire will be totaled. Oxford Knee Score Scale range 0 (severe arthritis) - 48 (satisfactory joint function)

    Measured: 36 months

  2. Change in Knee Society Score (KSS)

    The Knee Society Score (KSS) is comprised of 4 components: 1) An "Objective" Knee Score (7 items: 100 points), 2) A Patient Satisfaction Score (5 items: 40 points), 3) A Patient Expectation Score (3 items: 15 points), and 4) A Functional Activity Score (19 items: 100 points). Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

    Measured: 36 months

  3. Quantitative analysis of gait using EMG and motion capture

    A ten-camera infrared motion capture system will be used to track patients gait in a Biomechanics Laboratory. Retroreflective markers will be placed on the body in various locations to track muscle activity. Patients will be asked to perform 5 trials of level walking, 5 trials of inclined and declined walking (12.5% slope), 5 trials of going up and down stairs and 5 trials of sitting and standing motions. Only patients exhibiting the following characteristics will be suitable for assessment: BMI of 35 or less, No other ipsilateral or contralateral lower limb joint disorders.

    Measured: 12 months

  4. Short Term Recovery

    Patients recovery will be evaluated using the 40 item, quality of recovery (QoR-40) questionnaire. The sum of all scores (the total) will be reported (Minimum=40, Maximum=200). Higher scores are indicative of better perceived recovery while lower scores are associated with a worse perceived recovery.

    Measured: 6 months

  5. Clinical Measures

    Patient complications (if any) will be recorded by the surgeon during post-operative clinical assessments.

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2018
  2. Study startJan 2021 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Why it stopped: Lack of study funding

Resources

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457051
Sponsor's protocol ID
OHREB # 20120904-01H
Status last verified
Jun 2021
First submitted
28 Nov 2014
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Total Knee Arthroplasty (TKA) and Unicompartmental Knee Arthroplasty (UKA) in people with Osteoarthritis, Knee, run by Ottawa Hospital Research Institute 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 0 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: withdrawn, as of the sponsor's last update on 2 Jul 2021. 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 was withdrawn before enrolling participants, so there are no results.

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?

Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (time frame: 36 months). 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 NCT03457051.

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 2 Jul 2021.

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