search
Back to results

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

Primary Purpose

Osteoarthritis, Knee

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Total Knee Arthroplasty (TKA)
Unicompartmental Knee Arthroplasty (UKA)
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Inclusion criteria must and will be restricted to those patients who are generally considered candidates for UKA. Specific inclusion criteria will be restricted to patients:

  • Who report that most of their pain (greater than 75%) is located in the medial part of the knee on a regular basis.
  • With active range of motion from 10° of extension to 100° of flexion.
  • With an intact, competent, anterior cruciate ligament.
  • With overall limb alignment correctable to neutral, indicating a competent medial collateral ligament.
  • With radiographs showing primarily bone-on-bone disease in the medial compartment with minimal wear in both the lateral and patellofemoral compartments of the knee.
  • 50 to 80 years of age.
  • With a Body Mass Index (BMI) less than 40.

For the secondary outcome of motion analysis, 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

Exclusion Criteria:

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

Sites / Locations

  • The Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Total Knee Arthroplasty (TKA)

Unicompartmental Knee Arthroplasty (UKA)

Arm Description

In 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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2014
Last Updated
June 30, 2021
Sponsor
Ottawa Hospital Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03457051
Brief Title
Unicompartmental Knee Arthroplasty (UKA) Versus Total Knee Arthroplasty (TKA) of Medial Osteoarthritis
Official Title
A Randomized Trial Comparing Outcomes of Unicompartmental and Total Knee Replacement for Isolated Medial Osteoarthritis: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of study funding
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total Knee Arthroplasty (TKA)
Arm Type
Active Comparator
Arm Description
In 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.
Arm Title
Unicompartmental Knee Arthroplasty (UKA)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Total Knee Arthroplasty (TKA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Unicompartmental Knee Arthroplasty (UKA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Description
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).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Change in Oxford Knee Score (OKS)
Description
Patient-reported questionnaire. The sum of the questionnaire will be totaled. Oxford Knee Score Scale range 0 (severe arthritis) - 48 (satisfactory joint function)
Time Frame
36 months
Title
Change in Knee Society Score (KSS)
Description
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.
Time Frame
36 months
Title
Quantitative analysis of gait using EMG and motion capture
Description
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.
Time Frame
12 months
Title
Short Term Recovery
Description
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.
Time Frame
6 months
Title
Clinical Measures
Description
Patient complications (if any) will be recorded by the surgeon during post-operative clinical assessments.
Time Frame
6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:Inclusion criteria must and will be restricted to those patients who are generally considered candidates for UKA. Specific inclusion criteria will be restricted to patients: Who report that most of their pain (greater than 75%) is located in the medial part of the knee on a regular basis. With active range of motion from 10° of extension to 100° of flexion. With an intact, competent, anterior cruciate ligament. With overall limb alignment correctable to neutral, indicating a competent medial collateral ligament. With radiographs showing primarily bone-on-bone disease in the medial compartment with minimal wear in both the lateral and patellofemoral compartments of the knee. 50 to 80 years of age. With a Body Mass Index (BMI) less than 40. For the secondary outcome of motion analysis, 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 Exclusion Criteria: Those with inflammatory arthritis Those with no fixed address Those unable to commit to study requirements and follow-ups
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Dervin, MD,MSc,FRCSC
Organizational Affiliation
OHRI / The Ottawa Hospital/ University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs