Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 04-749, Poland
NCT Number: NCT04611815
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Warsaw, Masovian Voivodeship, 04-749, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.
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, 6-8 weeks post-operatively and 12 months post-operatively.
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.
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.
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.
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.
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: [Time Frame: 1 week and 6-8 weeks post-operatively]
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, 6-8 weeks and 6 months post- operatively
To explore differences in higher levels of activity and social participation
Time frame: Time Frame: 6-8 weeks and 6 months post-operatively
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 12 months post-operatively
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: preoperatively, 6-8 weeks and 12 months post-operatively
To explore differences in range of motion (flexion and extension)
Time frame: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
To asses evolution of post-operative knee pain
Time frame: Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
To count and asses all complications that may occur during surgery and in postoperative period
Time frame: Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
To count and asses the reason of all revision surgeries that may occur during postoperative period
Time frame: Time Frame: 6-8 weeks and 12 months post-operatively
To asses "up and go" time
Time frame: Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
To measure number of days counting from surgery to the discharge
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
Overground walking is measured using 3D Motion analysis and electromyography (EMG)
Time frame: Time Frame: at baseline preoperatively and 6 weeks post- operatively
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: 6-8 weeks and 12 months post-operatively
to asses pace and model of 6-minute walk
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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
Static balance is measured using a force plate
Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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 measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.
Medical University of Warsaw
Other
Does Robotic-assisted Total Knee Arthroplasty Improves Functional Outcome and Gait Pattern in Comparison to Conventional Total Knee Arthroplasty With Use of Bicruciate-stabilized (BS) Implant? Randmized-controlled Trial
Acronym: RATKA
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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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