Back to resultsA Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
Primary Purpose
Non-inflammatory Degenerative Joint Disease
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Stryker Triathlon Primary Total Knee System
Restoris MCK Multicompartmental Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Non-inflammatory Degenerative Joint Disease
Eligibility Criteria
Inclusion Criteria:
- The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
- The patient has no fixed flexion greater than 10 degrees.
- The patient has maximal flexion greater than 100 degrees
- The patient has a passively correctable varus deformity
- The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
- The patient has no significant patellofemoral malalignment
- The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
- The patient has pain that is not localised to the medial compartment only
- The patient is a male or non-pregnant female.
- The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion Criteria:
- The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
- The patient is undergoing revision surgery
- The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
- The patient has active, local infection or previous intra-articular infection
- The patient has skeletal immaturity
- The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
- The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
- The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
- Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
- Patients with tricompartmental disease are contraindicated from the study
Sites / Locations
- Perth Hip & Knee
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bicompartmental Knee Replacement (BKR)
Total Knee Replacement (TKR)
Arm Description
Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
Length of Hospital Stay
To compare length of hospital stay between the two arms of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02650284
Brief Title
A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
Official Title
A Prospective, Randomised Controlled Trial Evaluating Total Knee Replacement With the Stryker Triathlon Primary Total Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako, Compared to Bicompartmental Knee Replacement With Restoris MCK Multicompartmental Knee System Performed Using Stryker's Robotic-arm Assisted Surgery System, Mako
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Participant recruitment difficulties. Ruling to terminate study made Oct 2019
Study Start Date
August 12, 2015 (Actual)
Primary Completion Date
March 6, 2019 (Actual)
Study Completion Date
March 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker South Pacific
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-inflammatory Degenerative Joint Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bicompartmental Knee Replacement (BKR)
Arm Type
Other
Arm Description
Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Arm Title
Total Knee Replacement (TKR)
Arm Type
Other
Arm Description
Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Intervention Type
Device
Intervention Name(s)
Stryker Triathlon Primary Total Knee System
Intervention Description
Total Knee Replacement
Intervention Type
Device
Intervention Name(s)
Restoris MCK Multicompartmental Knee System
Intervention Description
Bicompartmental Knee Replacement
Primary Outcome Measure Information:
Title
Oxford Knee Score
Description
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
Secondary Outcome Measure Information:
Title
Health Related Quality of Life EQ-5D
Description
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
Title
VAS Pain
Description
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
Title
New Knee Society Score (KSS)
Description
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.
Time Frame
24 months/ 2years
Title
Forgotten Joint Score (FJS)
Description
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
Title
Incidence of Loosening, Reoperation and Revision
Description
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
Title
Length of Hospital Stay
Description
To compare length of hospital stay between the two arms of the study
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is a suitable candidate for a Bicompartmental Knee Replacement and has moderate to severe patellofemoral wear and medial compartment wear (surgeons discretion)
The patient has no fixed flexion greater than 10 degrees.
The patient has maximal flexion greater than 100 degrees
The patient has a passively correctable varus deformity
The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
The patient has no significant patellofemoral malalignment
The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
The patient has pain that is not localised to the medial compartment only
The patient is a male or non-pregnant female.
The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion Criteria:
The patient has a clinically deficient ACL and cruciate and collateral ligament insufficiency on CT arthrogram.
The patient is undergoing revision surgery
The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
The patient has active, local infection or previous intra-articular infection
The patient has skeletal immaturity
The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
Patients with tricompartmental disease are contraindicated from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gavin Clark, Dr
Organizational Affiliation
Perth Hip and Knee and St John of God Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perth Hip & Knee
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
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A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
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