- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611815
Robotic-assisted Total Knee Arthroplasty vs. Conventional One (RATKA)
September 12, 2022 updated by: Medical University of Warsaw
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Mazovia
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Warsaw, Mazovia, Poland, 04-749
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Robotic-assisted total knee arthroplasty
Patients undergoing robotic-assisted total knee arthroplasty with use of Journey II BCS implants
|
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
|
Active Comparator: Conventional total knee arthroplasty
Patients undergoing conventional total knee arthroplasty with use of Journey II BCS implants
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At baseline (preoperatively), 6-8 weeks and 12 months postoperatively.
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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.
|
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)
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.
|
At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
|
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.
|
At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
|
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.
|
At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
|
*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.
|
At baseline, 6-8 weeks post-operatively and 12 months post-operatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
[Time Frame: 1 week and 6-8 weeks post-operatively]
|
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
|
Time Frame: 1 week, 6-8 weeks and 6 months post- operatively
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Changes in patients reported outcomes - Forgotten Joint Score (FJS)
Time Frame: Time Frame: 6-8 weeks and 6 months post-operatively
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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: 6-8 weeks and 6 months post-operatively
|
Changes in patients reported outcomes - UCLA (University of California) score
Time Frame: Time Frame: 6-8 weeks and 12 months post-operatively
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To explore differences in patient's physical activity.
Results range from 0 to 10, with higher scores corresponding to better outcomes.
|
Time Frame: 6-8 weeks and 12 months post-operatively
|
Changes in knee range of motion
Time Frame: Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively
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To explore differences in range of motion (flexion and extension)
|
Time Frame: preoperatively, 6-8 weeks and 12 months post-operatively
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Changes in pain medication
Time Frame: Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
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To asses evolution of post-operative knee pain
|
Time Frame: 1 week, 6-8 weeks and 3-6 months post-operatively
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arthroplasty related complications
Time Frame: Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
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To count and asses all complications that may occur during surgery and in postoperative period
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Time Frame: 1 week post- operatively, 6-8 weeks post-operatively and 6-12 months post-operatively
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arthroplasty revision surgeries
Time Frame: Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
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To count and asses the reason of all revision surgeries that may occur during postoperative period
|
Time Frame: 1 week, 6-8 weeks and 12 months post-operatively
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walking abilities
Time Frame: Time Frame: 6-8 weeks and 12 months post-operatively
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To asses "up and go" time
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Time Frame: 6-8 weeks and 12 months post-operatively
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Length of hospital stay
Time Frame: Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
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To measure number of days counting from surgery to the discharge
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Time Frame: from baseline to discharge from hospital ranging averagely from 1 up to 7 days postoperatively
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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)
|
Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
|
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)
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Time Frame: at baseline preoperatively and 6 weeks post- operatively
|
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
|
Time Frame: 6-8 weeks and 12 months post-operatively
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Biomechanical stair climbing outcomes
Time Frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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Stair climbing and descending is measured using 3D Motion analysis and EMG
|
Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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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
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Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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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)
|
Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
|
Leg muscle strength outcomes
Time Frame: Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
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Leg muscle strength measured using maximal voluntary isometric contraction (MVIC) test of the hamstring and quadriceps muscles on both limbs.
|
Time Frame: at baseline, 6-8 weeks and 12 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
October 26, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
November 2, 2020
Study Record Updates
Last Update Posted (Actual)
September 15, 2022
Last Update Submitted That Met QC Criteria
September 12, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WarsawMU/RATKA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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