Nicholas Clement
Edinburgh, Lothian, EH16 6SA, United Kingdom
Location status: Recruiting
Location contact
James T Patton, FRCS
CONTACT
(+44)131 536 1000
Nicholas D Clement, MD, PhD
CONTACT
(+44)131 536 1000
NCT Number: NCT05290818
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.
Interested in participating?
Request Info50 year–75 year
All sexes
Interventional
Not applicable
Edinburgh, Lothian, EH16 6SA, United Kingdom
Location status: Recruiting
James T Patton, FRCS
CONTACT
(+44)131 536 1000
Nicholas D Clement, MD, PhD
CONTACT
(+44)131 536 1000
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The robotic-arm will be used to position a partial knee arthroplasty.
Other names: Robotic-arm assisted partial knee arthroplasty
Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.
Other names: Total Knee Replacement
Time frame: Baseline to 6 months
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 3, 6 and 12 months
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
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: 3, 6 and 12 months
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: Baseline to 3, 6 and 12 months
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
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, and projected for the patients lifetime
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
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
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'.
Contact information is provided by the study sponsor or research team.
James T Patton, FRCS
CONTACT
Nicholas D Clement, MD, PhD
CONTACT
NHS Lothian
Other Gov
Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial
Acronym: TRAKER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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