NCT04611815

Robotic-assisted Total Knee Arthroplasty vs. Conventional One

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteo Arthritis Knee
• Knee Arthritis
• Knee Pain Chronic

Interventions

Type	Name	Description
PROCEDURE	Total knee arthroplasty	Participant will undergo robotic-assisted or conventional total knee arthroplasty
DIAGNOSTIC_TEST	Computer tomography scan	CT scans of the affected knee joint before and after the surgical procedure
DIAGNOSTIC_TEST	biomechanical assesment	Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-12-31
• Completion: 2022-08-01
• First posted: 2020-11-02
• Last updated: 2022-09-15

Locations

1 site across 1 country: Poland