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

NCT ID: NCT03457051

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2025-09-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total Knee Arthroplasty (TKA)

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.

Group Type: ACTIVE_COMPARATOR

Total Knee Arthroplasty (TKA)

Intervention Type: PROCEDURE

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)

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

Group Type: EXPERIMENTAL

Unicompartmental Knee Arthroplasty (UKA)

Intervention Type: PROCEDURE

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.

Interventions

Total Knee Arthroplasty (TKA)

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

Unicompartmental Knee Arthroplasty (UKA)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Dervin, MD,MSc,FRCSC

Role: PRINCIPAL_INVESTIGATOR

OHRI / The Ottawa Hospital/ University of Ottawa

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

OHREB # 20120904-01H

Identifier Type: -

Identifier Source: org_study_id