Study Stopped
Lack of study funding
Unicompartmental Knee Arthroplasty (UKA) Versus Total Knee Arthroplasty (TKA) of Medial Osteoarthritis
A Randomized Trial Comparing Outcomes of Unicompartmental and Total Knee Replacement for Isolated Medial Osteoarthritis: A Feasibility Study
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJuly 2, 2021
June 1, 2021
4.7 years
November 28, 2014
June 30, 2021
Conditions
Outcome Measures
Primary Outcomes (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).
36 months
Secondary Outcomes (5)
Change in Oxford Knee Score (OKS)
36 months
Change in Knee Society Score (KSS)
36 months
Quantitative analysis of gait using EMG and motion capture
12 months
Short Term Recovery
6 months
Clinical Measures
6months
Study Arms (2)
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.
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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- Those with inflammatory arthritis
- Those with no fixed address
- Those unable to commit to study requirements and follow-ups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Dervin, MD,MSc,FRCSC
OHRI / The Ottawa Hospital/ University of Ottawa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2014
First Posted
March 7, 2018
Study Start
January 1, 2021
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
July 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share