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Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER)

Primary Purpose

Osteo Arthritis Knee, Arthritis Knee, Arthropathy of Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MAKO™ Partial Knee Arthroplasty
Triathlon (Stryker) Total Knee Arthroplasty
Sponsored by
NHS Lothian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Arthroplasty, Robotic, Knee, Total, Partial, Outcome, MAKO

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Listed for elective primary TKA for end stage medial compartment osteoarthritis
  • Intact anterior cruciate ligament
  • Full thickness and good quality lateral cartilage
  • Correctable intra-articular varus deformity and intact medial collateral ligament
  • American Society of Anesthesiologists (ASA) grades 1 and 2
  • Male or female, age 50 - 75 at the time of listing for surgery
  • Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA

Exclusion Criteria:

  • Varus deformity of > 20 degrees
  • Fixed flexion of >10 degrees
  • Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study
  • Requires patella resurfacing or lateral compartment has significant OA
  • Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
  • Inflammatory disorder e.g. rheumatoid arthritis
  • Symptomatic foot, hip or spine pathology
  • Prior surgery (other than arthroscopy) or septic arthritis of the knee
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,

Sites / Locations

  • Nicholas Clement

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual Total Knee Arthroplasty

Robotic Assisted Unicompartmental Knee Arthroplasty

Arm Description

This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the "feel" though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.

This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.

Outcomes

Primary Outcome Measures

Oxford knee score
Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best).

Secondary Outcome Measures

Oxford knee score and Activity and Participation Questionnaire
The Oxford knee score is a knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best). The additional Activity and Participation Questionnaire is a higher functioning supplementary questionnaire consisting of a further eight questions scored 0 (worst) to 4 (best).
Forgotten Joint Score
Knee specific functional outcome. It uses a five-point Likert response format, consisting of 12 equally weighted questions with the raw score transformed to range from zero (worst) to 100 (best) points.
Patient satisfaction
Patient satisfaction will be assessed following surgery by asking four questions with a different focus: i. "Overall how satisfied are you with the results of your knee replacement surgery?" ii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do housework or yard work (such as cooking, cleaning, or gardening and raking leaves)?" iii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do recreational activities (such as taking walks, swimming, bicycling, playing golf, dancing, going out with friends)?" iv. "How satisfied are you with the results of your knee replacement surgery for relieving your pain?" The response to each question will be recorded using a four point Likert scale: very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied.
EQ-5D-3L
Quality of life will be assessed using the EQ-5D-3L general health questionnaire which evaluates five domains (-5D), which include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This is a two page questionnaire that consists of five dimensions, with the responses recorded at three levels (3L) of severity (no problems; some problems or extreme problems). The utility index is on a scale of -0.594 to 1, where 1 represents perfect health and a negative value represents a state perceived as worse than death. The second page consists of a standard vertical 20cm visual analogue scale (EQ-5D VAS) which is transformed to a scale of 0 (worst) to 100 (best) measuring current health-related quality of life. Each patient's health state, derived from the EQ-5D, will be measured before and after their surgery to determine the change in their health gain or loss after their knee replacement surgery.
Range of movement
A goniometer will be used to measure range of movement by a blinded researcher prior to surgery (baseline), at discharge (immediately post surgery prior to discharge home) and at review appoints. Three measurements will be recorded for extension and flexion of the knee and an average will be documented.
Cost effectiveness
Cost utility analysis will be undertaken to establish the incremental cost effectiveness ratio (ICER). Each patient's health state, derived from the EQ-5D, will be measured before and after their surgery to determine the change in their health gain or loss after their knee replacement surgery. The health state will then be multiplied by the time spent in that state to derive the QALYs gained or lost. The cost per QALY will then be calculated by dividing the cost of the procedure by the QALYs gained after total knee arthroplasty (intervention). A health service resource use questionnaire will be completed by the patient at the 3, 6 and 12 month research assessment. The questionnaire collects data on primary, secondary and community care and associated with the knee replacement over the previous months. Inpatient and surgical data will be collected on the case report forms (CRF's) and complications will be recorded at each visit.
Knee stability and power
Knee stability (stress testing) and power (power rig) will be measured. A stress will be applied to the knee and the joint space opening will be measured using an ultrasound probe which will be used as a marker of knee stability. The power of the knee joint will be assessed using a standardise power rig Specific assessment of the patient's power output will be evaluated by a Leg Extensor Power Rig (Nottingham, UK), well validated for use with this population group.
Patient expectation pre-operative and fulfilment
The Hospital of Special Surgery Expectation questionnaire is a validated measure of patient pre-operative expectations of surgery. The level of patient expectation is indicated on a 5 point Likert scale as 'very important', 'somewhat important', 'a little important', 'I do not expect this' or 'this does not apply to me'. After surgery patients will complete a similar expectation questionnaire, but are asked whether the same expectations had been fulfilled, which again is assessed on a 5 point Likert scale as: 'greatly', 'a lot', 'a little', 'I did not expect this' or 'this did not apply to me'.

Full Information

First Posted
February 16, 2022
Last Updated
June 8, 2022
Sponsor
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT05290818
Brief Title
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Acronym
TRAKER
Official Title
Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Lothian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.
Detailed Description
Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment. Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease. The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee. A single centre randomised control trial will be carried out powered to the Oxford knee score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Arthritis Knee, Arthropathy of Knee
Keywords
Arthroplasty, Robotic, Knee, Total, Partial, Outcome, MAKO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control Trial (1:2 ratio: 53 in the rUKA arm and 106 in the mTKA)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Total Knee Arthroplasty
Arm Type
Active Comparator
Arm Description
This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the "feel" though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.
Arm Title
Robotic Assisted Unicompartmental Knee Arthroplasty
Arm Type
Experimental
Arm Description
This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.
Intervention Type
Device
Intervention Name(s)
MAKO™ Partial Knee Arthroplasty
Other Intervention Name(s)
Robotic-arm assisted partial knee arthroplasty
Intervention Description
The robotic-arm will be used to position a partial knee arthroplasty.
Intervention Type
Device
Intervention Name(s)
Triathlon (Stryker) Total Knee Arthroplasty
Other Intervention Name(s)
Total Knee Replacement
Intervention Description
Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.
Primary Outcome Measure Information:
Title
Oxford knee score
Description
Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best).
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Oxford knee score and Activity and Participation Questionnaire
Description
The Oxford knee score is a knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best). The additional Activity and Participation Questionnaire is a higher functioning supplementary questionnaire consisting of a further eight questions scored 0 (worst) to 4 (best).
Time Frame
Baseline to 3, 6 and 12 months
Title
Forgotten Joint Score
Description
Knee specific functional outcome. It uses a five-point Likert response format, consisting of 12 equally weighted questions with the raw score transformed to range from zero (worst) to 100 (best) points.
Time Frame
Baseline to 3, 6 and 12 months
Title
Patient satisfaction
Description
Patient satisfaction will be assessed following surgery by asking four questions with a different focus: i. "Overall how satisfied are you with the results of your knee replacement surgery?" ii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do housework or yard work (such as cooking, cleaning, or gardening and raking leaves)?" iii. "How satisfied are you with the results of your knee replacement surgery for improving your ability to do recreational activities (such as taking walks, swimming, bicycling, playing golf, dancing, going out with friends)?" iv. "How satisfied are you with the results of your knee replacement surgery for relieving your pain?" The response to each question will be recorded using a four point Likert scale: very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied.
Time Frame
3, 6 and 12 months
Title
EQ-5D-3L
Description
Quality of life will be assessed using the EQ-5D-3L general health questionnaire which evaluates five domains (-5D), which include: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This is a two page questionnaire that consists of five dimensions, with the responses recorded at three levels (3L) of severity (no problems; some problems or extreme problems). The utility index is on a scale of -0.594 to 1, where 1 represents perfect health and a negative value represents a state perceived as worse than death. The second page consists of a standard vertical 20cm visual analogue scale (EQ-5D VAS) which is transformed to a scale of 0 (worst) to 100 (best) measuring current health-related quality of life. Each patient's health state, derived from the EQ-5D, will be measured before and after their surgery to determine the change in their health gain or loss after their knee replacement surgery.
Time Frame
Baseline to 3, 6 and 12 months
Title
Range of movement
Description
A goniometer will be used to measure range of movement by a blinded researcher prior to surgery (baseline), at discharge (immediately post surgery prior to discharge home) and at review appoints. Three measurements will be recorded for extension and flexion of the knee and an average will be documented.
Time Frame
Baseline to 3, 6 and 12 months
Title
Cost effectiveness
Description
Cost utility analysis will be undertaken to establish the incremental cost effectiveness ratio (ICER). Each patient's health state, derived from the EQ-5D, will be measured before and after their surgery to determine the change in their health gain or loss after their knee replacement surgery. The health state will then be multiplied by the time spent in that state to derive the QALYs gained or lost. The cost per QALY will then be calculated by dividing the cost of the procedure by the QALYs gained after total knee arthroplasty (intervention). A health service resource use questionnaire will be completed by the patient at the 3, 6 and 12 month research assessment. The questionnaire collects data on primary, secondary and community care and associated with the knee replacement over the previous months. Inpatient and surgical data will be collected on the case report forms (CRF's) and complications will be recorded at each visit.
Time Frame
Baseline to 3, 6 and 12 months, and projected for the patients lifetime
Title
Knee stability and power
Description
Knee stability (stress testing) and power (power rig) will be measured. A stress will be applied to the knee and the joint space opening will be measured using an ultrasound probe which will be used as a marker of knee stability. The power of the knee joint will be assessed using a standardise power rig Specific assessment of the patient's power output will be evaluated by a Leg Extensor Power Rig (Nottingham, UK), well validated for use with this population group.
Time Frame
Baseline to 3, 6 and 12 months
Title
Patient expectation pre-operative and fulfilment
Description
The Hospital of Special Surgery Expectation questionnaire is a validated measure of patient pre-operative expectations of surgery. The level of patient expectation is indicated on a 5 point Likert scale as 'very important', 'somewhat important', 'a little important', 'I do not expect this' or 'this does not apply to me'. After surgery patients will complete a similar expectation questionnaire, but are asked whether the same expectations had been fulfilled, which again is assessed on a 5 point Likert scale as: 'greatly', 'a lot', 'a little', 'I did not expect this' or 'this did not apply to me'.
Time Frame
Baseline to 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Listed for elective primary TKA for end stage medial compartment osteoarthritis Intact anterior cruciate ligament Full thickness and good quality lateral cartilage Correctable intra-articular varus deformity and intact medial collateral ligament American Society of Anesthesiologists (ASA) grades 1 and 2 Male or female, age 50 - 75 at the time of listing for surgery Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA Exclusion Criteria: Varus deformity of > 20 degrees Fixed flexion of >10 degrees Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments Female participants who are pregnant, lactating or planning pregnancy during the course of the study Requires patella resurfacing or lateral compartment has significant OA Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons Inflammatory disorder e.g. rheumatoid arthritis Symptomatic foot, hip or spine pathology Prior surgery (other than arthroscopy) or septic arthritis of the knee Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas D Clement, MD, PhD
Phone
+44 131 536 1000
Email
nick.clement@nhslothian.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
James T Patton, FRCS
Phone
+44 131 536 1000
Email
Sam.Patton@nhslothian.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas D Clement, MD, PhD
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicholas Clement
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH16 6SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual patient data available.
Citations:
PubMed Identifier
31256672
Citation
Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1.
Results Reference
background
PubMed Identifier
32435451
Citation
Clement ND, Bell A, Simpson P, Macpherson G, Patton JT, Hamilton DF. Robotic-assisted unicompartmental knee arthroplasty has a greater early functional outcome when compared to manual total knee arthroplasty for isolated medial compartment arthritis. Bone Joint Res. 2020 May 16;9(1):15-22. doi: 10.1302/2046-3758.91.BJR-2019-0147.R1. eCollection 2020 Jan.
Results Reference
background
PubMed Identifier
31474149
Citation
Clement ND, Deehan DJ, Patton JT. Robot-assisted unicompartmental knee arthroplasty for patients with isolated medial compartment osteoarthritis is cost-effective: a markov decision analysis. Bone Joint J. 2019 Sep;101-B(9):1063-1070. doi: 10.1302/0301-620X.101B9.BJJ-2018-1658.R1. Erratum In: Bone Joint J. 2019 Nov;101-B(11):1464.
Results Reference
background
Links:
URL
https://edinburghorthopaedics.org/
Description
Home page of Edinburgh Orthopaedics

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Total Versus Robotic Assisted Unicompartmental Knee Replacement

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