Osteoarthritis, KneeRATKA-CBONCT04912973
Assessment With Gait Analysis of Robotic Total Knee Arthroplasty Using Inverse Kinematic Alignment
A study testing Robotically Assisted Total Knee Arthroplasty - Knee Replacement in people with Osteoarthritis, Knee, run by Philip Winnock de Grave, MD at 1 site in Belgium.
Trial summary
Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Robotically Assisted Total Knee Arthroplasty - Knee Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to Jan 2024
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures
- Received a primary total knee replacement (incl. patella) robotically-assisted
- Male or female
- Age between 50 and 80
- Able to walk independently
Who cannot join
- Revision surgery
- Patient with a history of neurological, psychiatric or neurodegenerative disease
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Other musculoskeletal lesions that may affect the gait pattern
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing
Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Robotically Assisted Total Knee Arthroplasty - Knee Replacement
- Keywords
- total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically Assisted Total Knee Arthroplasty - Knee ReplacementProcedure or surgery
Also called Triathlon Total Knee System of Stryker with Mako Robotic Platform, Triathlon Total Knee Replacement of Stryker
Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy
| Study group | Role | What they receive |
|---|---|---|
| inverse Kinematic Alignment | Active comparator | Not described Receives: Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement |
| adjusted Mechanical Alignment | Active comparator | Not described Receives: Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Analysis - walking speed - faster is better
Spatio Temporal Parameters are captured with infra-red camera during gait: velocity
Measured: 2 year
Performance Testing - step-up step-down speed - faster is better
Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity
Measured: 2 year
Secondary outcomes (1)
Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48
Questionnaire - Oxford Knee Score
Measured: baseline - 1 year - 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2024 (estimated)
- Study completionJan 2024 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Winnock de Grave, MD
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Delta
- Responsible party
- Sponsor-investigator, Philip Winnock de Grave, MD, AZ Delta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912973
- Sponsor's protocol ID
- B3222020000151
- Acronym
- RATKA-CBO
- Status last verified
- Jul 2023
- First submitted
- 17 May 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & Biomechanical Outcome After Robotic Total Knee Arthroplasty by Comparing Inverse Kinematic Alignment and Mechanical Alignment - Gait Analysis and Performance Testing
- ClinicalTrials.gov ID
- NCT04912973
- Acronym / sponsor ID
- RATKA-CBO / B3222020000151
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee arthroplasty, robotic surgery, alignment, inverse kinematic alignment, mechanical alignment, gait analysis, performance testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Philip Winnock de Grave, MDUniversity, hospital or other
- Collaborators
- AZ Delta
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 3 Jun 2021 (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.
Postoperative function and patient satisfaction are becoming increasingly relevant in patients after knee arthroplasty surgery. Despite adequate preoperative planning, improved surgical techniques and rehabilitation protocols, only 75%-85% of patients seems satisfied after TKA procedurs. Implant positioning and component alignment are determining factors in patient outcome. Currently, different alignment strategies in TKA surgery are used such as Mechanical Alignment (MA) and Kinematical Alignment (KA). Recently, a new and individualized alignment strategy (inverse Kinematic Alignment/iKA) was introduced. Preliminary 1-year results of iKA are promising, however, clinical and functional outcome on the medium and longterm should be investigated. This project aims to compare patients with iKA TKA with MA TKA on clinical, functional and biomechanical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inverse Kinematic Alignment | Active comparator | Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement |
| adjusted Mechanical Alignment | Active comparator | Procedure: Robotically Assisted Total Knee Arthroplasty - Knee Replacement |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent must be obtained prior to any screening procedures
- Received a primary total knee replacement (incl. patella) robotically-assisted
- Male or female
- Age between 50 and 80
- Able to walk independently
Key exclusion criteria (4 listed)
- Revision surgery
- Patient with a history of neurological, psychiatric or neurodegenerative disease
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Other musculoskeletal lesions that may affect the gait pattern
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 |
|---|---|---|
| Robotically Assisted Total Knee Arthroplasty - Knee ReplacementAlso: Triathlon Total Knee System of Stryker with Mako Robotic Platform, Triathlon Total Knee Replacement of StrykerRobotically Assisted Total Knee Arthroplasty with a particular alignment strategy | Procedure or surgery | adjusted Mechanical Alignment, inverse Kinematic Alignment |
Primary outcome
Gait Analysis - walking speed - faster is better
Time frame: 2 year
Spatio Temporal Parameters are captured with infra-red camera during gait: velocity
Performance Testing - step-up step-down speed - faster is better
Time frame: 2 year
Spatio Temporal Parameters are captured with infra-red camera during functional movements: velocity
1 secondary outcome
Patient Reported Outcome Measures - Oxford Knee Score (OKS): maximum score (best) is 48/48; worst score is 0/48
Time frame: baseline - 1 year - 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotically Assisted Total Knee Arthroplasty - Knee Replacement in people with Osteoarthritis, Knee, run by Philip Winnock de Grave, MD at 1 site in Belgium.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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 Belgium. 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?
Results are not available in the source record.
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?
Gait Analysis - walking speed - faster is better (time frame: 2 year). The study lists 2 primary outcomes in all. 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 20 Jul 2023.