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Completed

NCT Number: NCT04611815

Robotic-assisted Total Knee Arthroplasty vs. Conventional One

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 04-749, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Listed for a primary total knee replacement (TKR)
  • Indication for the TKR is primary osteoarthritis of the knee joint involving one or more compartments
  • Aged 18 or over
  • Patient willing to provide full informed consent to the trial

Exclusion criteria

  • Listed for a single-stage one-sided TKR procedure
  • Severe symptoms in the contralateral knee so as to require staged bilateral knee replacements within 6 months of the primary procedure
  • Fixed flexion deformity of 15 degrees or greater who will require excessive resection of the distal femur
  • Clinically assessed uncorrectable varus/valgus deformity of 15 degrees or greater
  • Any co-morbidity which, in the opinion of the investigator, is severe enough to present an unacceptable risk to the patient's safety
  • Inflammatory arthritis
  • Previous septic arthritis in the affected knee joint
  • Previous surgery to the collateral ligaments of the affected knee
  • A contralateral total knee replacement that has been implanted less than one year from the date of consultation
  • A contralateral total knee replacement that is severely painful
  • Patients on warfarin or novel oral anticoagulants (NOACs)
  • Will not be resident in the catchment area for at least 6 months post-surgery
  • Undertaking the surgery as a private patient
  • Patients who, in the opinion of the clinical staff, do not have capacity to consent
  • Patients who are pregnant
  • Unable to understand written and spoken Polish

Treatment and study plan

Total knee arthroplasty

Procedure

Participant will undergo robotic-assisted or conventional total knee arthroplasty

Computer tomography scan

Diagnostic Test

CT scans of the affected knee joint before and after the surgical procedure

biomechanical assesment

Diagnostic Test

Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively

Primary outcomes

  1. Changes in patients reported outcome measures - Oxford Knee Score (OKS)

    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.

  2. Changes in patients reported outcome measures - Knee injury and Osteoarthritis Outcome Score (KOOS)

    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.

  3. Changes in patients reported outcome measures - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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.

  4. Changes in patients reported outcome measures - Lysholm knee scoring scale

    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.

  5. Changes in patients range of motion (ROM)

    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.

  6. *We take into consideration the possible use of other PROM questionnaires and analysis of different adverse events depending on the unpredictable circumstances.

    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.

Secondary outcomes

  1. Changes in patients reported outcome measures - Oxford Knee Score (OKS)

    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.

  2. Changes in patients reported outcomes - Oxford Knee Score Activity & Participation Questionnaire (OKS_APQ)

    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

  3. Changes in patients reported outcomes - Forgotten Joint Score (FJS)

    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.

  4. Changes in patients reported outcomes - UCLA (University of California) score

    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.

  5. Changes in knee range of motion

    Time frame: Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively

    To explore differences in range of motion (flexion and extension)

  6. Changes in pain medication

    Time frame: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively

    To asses evolution of post-operative knee pain

  7. arthroplasty related complications

    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

  8. arthroplasty revision surgeries

    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

  9. walking abilities

    Time frame: Time Frame: 6-8 weeks and 12 months post-operatively

    To asses "up and go" time

  10. Length of hospital stay

    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

  11. Biomechanical 3D motion and emg walking outcomes

    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)

  12. Radiological outcome on CT scans

    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)

  13. 6- minute walking abilities

    Time frame: Time Frame: 6-8 weeks and 12 months post-operatively

    to asses pace and model of 6-minute walk

  14. Biomechanical stair climbing outcomes

    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

  15. Biomechanical static balance outcomes

    Time frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively

    Static balance is measured using a force plate

  16. Biomechanical dynamic balance outcomes

    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)

  17. Leg muscle strength outcomes

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 2, 2020
Registry last updated
Sep 15, 2022

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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