Clinical trial NCT03457051: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: 36 months
Secondary outcomes:
measure: Change in Oxford Knee Score (OKS)
timeFrame: 36 months
measure: Change in Knee Society Score (KSS)
timeFrame: 36 months
measure: Quantitative analysis of gait using EMG and motion capture
timeFrame: 12 months
measure: Short Term Recovery
timeFrame: 6 months
measure: Clinical Measures
timeFrame: 6months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI / The Ottawa Hospital/ University of Ottawa
name: Geoffrey Dervin, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: