Osteoarthritis, KneeNCT04307251
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty
A study testing Navio™ Robotics-assisted Surgical System, LEGION Total Knee System and Conventional, LEGION Total Knee System in people with Osteoarthritis, Knee, run by Navamindradhiraj University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Navio™ Robotics-assisted Surgical System, LEGION Total Knee System and Conventional, LEGION Total Knee System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteThailand
- Study dates
- 23 Mar 2020to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- Age 50-80 year
- Patients with osteoarthritis who voluntarily participated in the project
Who cannot join
- Patients with osteoporosis
- History of inflammatory arthroplathy
- Previous fracture or open surgery on the same knee
- Patients with bilateral total knee arthroplasty
- Patients osteoarthritis with revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty
- Conditions
- Osteoarthritis, Knee
- Being tested
- Navio™ Robotics-assisted Surgical System, LEGION Total Knee System, Conventional, LEGION Total Knee System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navio™ Robotics-assisted Surgical System, LEGION Total Knee SystemDevice
Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy.
Conventional, LEGION Total Knee SystemDevice
Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific.
| Study group | Role | What they receive |
|---|---|---|
| Navio™ Robotics-assisted Surgical System | Experimental | Not described Receives: Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System |
| Conventional, non-robotics-assisted total knee surgical system | Experimental | Not described Receives: Device: Conventional, LEGION Total Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical axis
Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus <age 2 and physiologic valgus <age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention
Measured: Change from baseline mechanical axis at 6 weeks after surgery
Secondary outcomes (3)
Knee Society and Knee Society function score
Knee Society and Knee Society function score (minimum 0, maximum 200)
Measured: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
Range of motion of knee
Range of motion of knee (minimum 0, maximum 140)
Measured: Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Oxford knee score (minimum 0, maximum 48)
Measured: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start23 Mar 2020
- Primary completion30 Jan 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satit Thiengwittayaporn, Navamindradhiraj University
- Investigators
- Satit Thiengwittayaporn, M.D., Principal investigator, Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307251
- Sponsor's protocol ID
- COA 012/2563
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04307251
- Acronym / sponsor ID
- COA 012/2563
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navio™ Robotics-assisted Surgical System | Experimental | Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System |
| Conventional, non-robotics-assisted total knee surgical system | Experimental | Device: Conventional, LEGION Total Knee System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- Age 50-80 year
- Patients with osteoarthritis who voluntarily participated in the project
Key exclusion criteria (5 listed)
- Patients with osteoporosis
- History of inflammatory arthroplathy
- Previous fracture or open surgery on the same knee
- Patients with bilateral total knee arthroplasty
- Patients osteoarthritis with revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navio™ Robotics-assisted Surgical System, LEGION Total Knee SystemRobotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy. | Device | Navio™ Robotics-assisted Surgical System |
| Conventional, LEGION Total Knee SystemTotal Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific. | Device | Conventional, non-robotics-assisted total knee surgical system |
Primary outcome
Mechanical axis
Time frame: Change from baseline mechanical axis at 6 weeks after surgery
Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus <age 2 and physiologic valgus <age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention
3 secondary outcomes
Knee Society and Knee Society function score
Time frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
Range of motion of knee
Time frame: Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Time frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satit Thiengwittayaporn, M.D. principal investigator
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navio™ Robotics-assisted Surgical System, LEGION Total Knee System and Conventional, LEGION Total Knee System in people with Osteoarthritis, Knee, run by Navamindradhiraj University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical axis (time frame: Change from baseline mechanical axis at 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.