This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing robotic-assisted total knee arthroplasty and conventional one.
Osteoarthritis causes the joints to become painful and stiff. Osteoarthritis of the knee is a common condition that is expected to be a lot more frequent in the next two decades. As a consequence, an increase of total knee replacement surgery is predicted. Total knee replacement surgery is offered when knee pain and stiffness caused by osteoarthritis can no longer be managed and these symptoms significantly impact on an individual's normal activities of daily living. Most total knee replacements are successful but up to 34% of all patients have poor functional outcomes following surgery. This leaves affected people at a greater risk of reduced physical activity and thus impacts longer-term general health. Poor outcomes are therefore of importance to patients and have a considerable financial and service-provision impact on National Health Service (NHS) care. While patient-related characteristics and their relationship to patient outcomes have been identified, few studies have been undertaken to determine how kinematic outcomes (how the prosthetic knee moves) are related to functional outcome and patient satisfaction. The kinematic outcome of a total knee replacement is hypothesised to relate to both the structural design (shape) of the implant and the surgical procedure itself. In recent years, there has been development of high technology tools to help surgeon restoring proper joint biomechanics. Nowadays on the market there are several robots designed to fulfill this function. To date, no studies have investigated the kinematic outcomes of robotic-assisted total knee arthroplasty in comparison to conventional surgery. Whilst it is known that long term success of total knee replacement depends largely upon correct alignment of the prosthesis components during surgery, no studies have looked at the anatomical alignments of the osteoarthritic knee prior to undergoing surgery (using Computerised Tomography (CT) scanning). The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) with use of the combination of either Oxford score or KOOS score with addition of WOMAC and Lysholm scores and CT measurement, both pre- and post-operatively, between robotic-assisted total knee arthroplasty and conventional surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Participant will undergo robotic-assisted or conventional total knee arthroplasty
CT scans of the affected knee joint before and after the surgical procedure
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.
Time frame: At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.
Changes in patients reported outcome measures - Knee injury and Osteoarthritis Outcome Score (KOOS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients reported outcome measures - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 96, with lower scores corresponding to better outcomes.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients reported outcome measures - Lysholm knee scoring scale
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients range of motion (ROM)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
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*We take into consideration the possible use of other PROM questionnaires and analysis of different adverse events depending on the unpredictable circumstances.
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time frame: At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
Changes in patients reported outcome measures - Oxford Knee Score (OKS)
To explore differences between outcome in patients treated with RATKA and conventional total knee arthroplasty. Results range from 0 to 48, with higher scores corresponding to better outcomes.
Time frame: [Time Frame: 1 week and 6-8 weeks post-operatively]
Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)
To explore differences in higher levels of activity and social participation
Time frame: Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
Changes in patients reported outcomes - Forgotten Joint Score (FJS)
To explore differences in patient's ability to forget about a joint as a result of successful treatment. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Time frame: Time Frame: 6-8 weeks and 6 months post-operatively
Changes in patients reported outcomes - UCLA (University of California) score
To explore differences in patient's physical activity. Results range from 0 to 10, with higher scores corresponding to better outcomes.
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Changes in knee range of motion
To explore differences in range of motion (flexion and extension)
Time frame: Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively
Changes in pain medication
To asses evolution of post-operative knee pain
Time frame: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
arthroplasty related complications
To count and asses all complications that may occur during surgery and in postoperative period
Time frame: Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
arthroplasty revision surgeries
To count and asses the reason of all revision surgeries that may occur during postoperative period
Time frame: Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
walking abilities
To asses "up and go" time
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Length of hospital stay
To measure number of days counting from surgery to the discharge
Time frame: Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
Biomechanical 3D motion and emg walking outcomes
Overground walking is measured using 3D Motion analysis and electromyography (EMG)
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Radiological outcome on CT scans
Rotational alignment of the total knee component is assessed by measuring the femoral antetorsion, Alignment of the total knee component is assessed by measuring the tibial tubercle-trochlear groove distance (TT-TG)
Time frame: Time Frame: at baseline preoperatively and 6 weeks post- operatively
6- minute walking abilities
to asses pace and model of 6-minute walk
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
Biomechanical stair climbing outcomes
Stair climbing and descending is measured using 3D Motion analysis and EMG
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical static balance outcomes
Static balance is measured using a force plate
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Biomechanical dynamic balance outcomes
Dynamic balance is measured using a force plate and the modified Star Excursion Balance Test (mSEBT)
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Leg muscle strength outcomes
Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively