A prospective, randomised controlled trial evaluating Total Knee Replacement with the Stryker Triathlon Primary Total Knee System, compared to Bicompartmental Knee Replacement with Restoris MCK Multicompartmental Knee System performed using Stryker's Robotic-arm assisted surgery system, Mako.
This study is a prospective, randomised clinical study comparing clinical outcomes of Knee Replacement using the Oxford Knee Score (OKS), in patients receiving either Bicompartmental Knee Replacement performed using Stryker's robotic-arm assisted surgery system Mako, to Total Knee Replacement using the Triathlon Total Knee System performed with either conventional instrumentation or navigation. Functional and radiographic outcomes will be additionally collected as part of this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Total Knee Replacement
Bicompartmental Knee Replacement
Perth Hip & Knee
Subiaco, Western Australia, Australia
Oxford Knee Score
Comparing clinical outcomes using the Oxford Knee Score. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.
Time frame: pre-op, 6 weeks, 3 months, 12 months, 24 months
Health Related Quality of Life EQ-5D
Comparing functional and clinical outcomes using the EQ-5D. The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. Index values range from 0-1, with 1 being representing "full health". The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'. The VAS scales represents health on the day.
Time frame: 24 months/ 2years
VAS Pain
Comparing functional and clinical outcomes using the VAS pain. Pain at rest and pain during mobilization are measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 100 being the worst pain.
Time frame: 24 months/ 2years
New Knee Society Score (KSS)
Comparing functional and clinical outcomes using the KSS. The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
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Time frame: 24 months/ 2years
Forgotten Joint Score (FJS)
Comparing functional and clinical outcomes using the FJS. The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).
Time frame: 24 months/ 2years
Incidence of Loosening, Reoperation and Revision
To compare incidence of loosening, reoperation and revision rates. The incidence (ie number of participants who experienced lossening, reoperation or revision) will be counted and presented as a whole number or percentage of the total number of patients, however they will be identified from analysing Xrays and checking Serious Adverse Event/ Adverse Event reports.
Time frame: 6 weeks, 3 months, 12 months, 24 months
Length of Hospital Stay
To compare length of hospital stay between the two arms of the study
Time frame: 6 weeks