Knee OsteoarthritisKnieathlonNCT06280352
Robotic Assisted vs Custom Made Total Knee Arthroplasty
A study testing Custom made Total Knee Arthroplasty and Functionally aligned robotically assisted total knee arthroplasty in people with Knee Osteoarthritis, run by Austrian Workers Compensation Board Styria at 2 sites in Austria.
Trial summary
The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are: Which implant/philosophy yields better clinical outcomes? Which implant/philosophy yields better satisfaction?… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Custom made Total Knee Arthroplasty and Functionally aligned robotically assisted total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Mar 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - The patient is a male or non-pregnant female between the ages of 40 and 90 years
- The patient requires a primary total knee replacement
- Patient is deemed appropriate for a cruciate retaining knee replacement
- The patient has a primary diagnosis of osteoarthritis (OA)
- The patient has intact collateral ligaments
- The patient is able to undergo CT scanning of the affected limb
- The patient has signed the study specific, ethics-approved, informed consent document
- The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Who cannot join
- - The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
- Patient has had a previous osteotomy around the knee
- The patient is morbidly obese (BMI > 41)
- The patient has a deformity which will require the use of stems, wedges or augments
- The patient has a varus deformity ≥ 15°
- The patient has a valgus deformity >3°
Show all 9Show fewer
- The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
- The patient is unable to speak German
- The patient is pregnant
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria2 sites, 2 recruiting
- Recruiting
AUVA UKH Steiermark Standort Graz
Graz, Styria, 8020
Antonio Klasan, MD, PHD, EMBA
- Recruiting
AUVA UKH Steiermark Standort Kalwang
Kalwang, Styria, 8775
Antonio Klasan, MD, PhD, EMBA
About this study
Official title: Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:
- Which implant/philosophy yields better clinical outcomes?
- Which implant/philosophy yields better satisfaction?
- Which system is more OR efficient? Participants will be followed for 2 years postoperatively.
- Conditions
- Knee Osteoarthritis
- Being tested
- Custom made Total Knee Arthroplasty, Functionally aligned robotically assisted total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made Total Knee ArthroplastyDevice
Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
Functionally aligned robotically assisted total knee arthroplastyDevice
Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy
| Study group | Role | What they receive |
|---|---|---|
| Custom made Total Knee Arthroplasty | Experimental | Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland) Receives: Device: Custom made Total Knee Arthroplasty |
| Functionally aligned robotically assisted total knee arthroplasty | Active comparator | Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker) Receives: Device: Functionally aligned robotically assisted total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome using the Forgotten Joint Score
Scale 0-100, higher score means better outcome
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary outcomes (9)
Clinical outcomes using the Kujala anterior knee pain Score
Scale 0-100, higher score means better outcome
Measured: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Patient satisfaction
Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied
Measured: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Visual analog pain (VAS) scale
Scale 0-10, higher score means better outcome
Measured: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Surgical and total theatre time
Measured: Perioperative phase
Opioid use
Total dosage of opioids, registered in Austria for pain management after knee replacement, administered to the patient during in-hospital stay: Hydromorphon, Tramadol, Oxycodone/Naloxon as well as number of ampules of Piritramid
Measured: Intraoperative stay
Number of physiotherapy sessions
Measured: Intraoperative stay
Range of motion measurements (in degrees)
Measurement using a manual goniometer.
Measured: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic data including radiolucent lines
Incidence of radiolucent lines >1 mm, with zones defined according to the New Knee Society Classification
Measured: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Revision rate
Measured: Minimum 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- Randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austrian Workers Compensation Board Styria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Klasan, Austrian Workers Compensation Board Styria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280352
- Sponsor's protocol ID
- AUVA_Knieathlon_2024
- Acronym
- Knieathlon
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06280352
- Acronym / sponsor ID
- Knieathlon / AUVA_Knieathlon_2024
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Austrian Workers Compensation Board StyriaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Feb 2024 (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 goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:
- Which implant/philosophy yields better clinical outcomes?
- Which implant/philosophy yields better satisfaction?
- Which system is more OR efficient? Participants will be followed for 2 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Custom made Total Knee Arthroplasty | Experimental | Device: Custom made Total Knee ArthroplastyImplant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland) |
| Functionally aligned robotically assisted total knee arthroplasty | Active comparator | Device: Functionally aligned robotically assisted total knee arthroplastyTotal Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - The patient is a male or non-pregnant female between the ages of 40 and 90 years
- The patient requires a primary total knee replacement
- Patient is deemed appropriate for a cruciate retaining knee replacement
- The patient has a primary diagnosis of osteoarthritis (OA)
- The patient has intact collateral ligaments
Key exclusion criteria (9 listed)
- - The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
- Patient has had a previous osteotomy around the knee
- The patient is morbidly obese (BMI > 41)
- The patient has a deformity which will require the use of stems, wedges or augments
- The patient has a varus deformity ≥ 15°
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 |
|---|---|---|
| Custom made Total Knee ArthroplastyTotal knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland) | Device | Custom made Total Knee Arthroplasty |
| Functionally aligned robotically assisted total knee arthroplastyTotal knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy | Device | Functionally aligned robotically assisted total knee arthroplasty |
Primary outcome
Clinical Outcome using the Forgotten Joint Score
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Scale 0-100, higher score means better outcome
9 secondary outcomes
Clinical outcomes using the Kujala anterior knee pain Score
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Patient satisfaction
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Visual analog pain (VAS) scale
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Surgical and total theatre time
Time frame: Perioperative phase
Opioid use
Time frame: Intraoperative stay
Number of physiotherapy sessions
Time frame: Intraoperative stay
Range of motion measurements (in degrees)
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Radiographic data including radiolucent lines
Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
Revision rate
Time frame: Minimum 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom made Total Knee Arthroplasty and Functionally aligned robotically assisted total knee arthroplasty in people with Knee Osteoarthritis, run by Austrian Workers Compensation Board Styria at 2 sites in Austria.
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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Klasan, MD, PhD, EMBA (+436765085920, klasan.antonio@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome using the Forgotten Joint Score (time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months). 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 28 Jan 2025.