Knee OsteoarthritisNCT06284824
Comparison of Two Robotic-Assisted Total Knee Arthroplasty Systems
A study testing Stryker Triathlon with MAKO Robotic-Arm and DePuy Attune with VELYS Robotic-Assistance in people with Knee Osteoarthritis and Knee Arthritis, run by Southeast Orthopedic Specialists.
Trial summary
The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis, Knee Disease
- What is being tested?
- Stryker Triathlon with MAKO Robotic-Arm and DePuy Attune with VELYS Robotic-Assistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
- Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
- Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
- Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
- Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.
Who cannot join
- Patient has a Body Mass Index (BMI) > 40.
- Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
- Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
- Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
- Subject is a woman who is pregnant or lactating.
- Patient has a contralateral amputation.
Show all 13Show fewer
- Patient's affected knee has a flexion contracture greater than 15 degrees.
- Patient has history of post operative arthrofibrosis.
- Patient's affected knee has a partial knee arthroplasty.
- Patient has undergone contralateral TKA within the last three months.
- Patient is currently involved in any personal injury litigation, medical-legal, or worker's compensation claims.
- Patient who is bedridden per the discretion of the investigator.
- Patient has a medical condition with less than 2 years of life expectancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.
The goal of this prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:
- Will the patient reported outcomes differ between the two groups?
- Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.
Read the detailed description
The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Disease
- Being tested
- Stryker Triathlon with MAKO Robotic-Arm, DePuy Attune with VELYS Robotic-Assistance
- Keywords
- robotic assistance, arthroplasty, TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stryker Triathlon with MAKO Robotic-ArmDevice
Implant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm
DePuy Attune with VELYS Robotic-AssistanceDevice
Implant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance
| Study group | Role | What they receive |
|---|---|---|
| MAKO group | Experimental | Patients in this arm will receive the Stryker Triathlon implant and the MAKO robotic arm will be used during surgery. Receives: Device: Stryker Triathlon with MAKO Robotic-Arm |
| VELYS group | Experimental | Patients in this arm will receive the DePuy Attune implant and the VELYS robotic arm will be used during surgery. Receives: Device: DePuy Attune with VELYS Robotic-Assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSS
Knee Society Score
Measured: baseline
KSS
Knee Society Score
Measured: 6 week
KSS
Knee Society Score
Measured: 12 week
KSS
Knee Society Score
Measured: 1 year
KOOS JR
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Measured: baseline
KOOS JR
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Measured: 6 week
KOOS JR
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Measured: 12 week
KOOS JR
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Measured: 1 year
FJS-12 Knee
Forgotten Joint Score
Measured: 6 week
FJS-12 Knee
Forgotten Joint Score
Measured: 12 week
FJS-12 Knee
Forgotten Joint Score
Measured: 1 year
Secondary outcomes (1)
Operative step time
Timing for use of robot during surgery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startMay 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Orthopedic Specialists
- Sponsor type
- Research network
- Collaborators
- DePuy Orthopaedics, Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- John Redmond, MD, Principal investigator, Southeast Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284824
- Sponsor's protocol ID
- DPS-JMP-2022-040
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single-center Study Comparing the Stryker MAKO™ Robotic-Arm Assisted Total Knee Arthroplasty and the DePuy VELYS™ Robotic-Assisted Solution for Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT06284824
- Acronym / sponsor ID
- DPS-JMP-2022-040
- Conditions
- Knee Osteoarthritis, Knee Arthritis, Knee Disease
- Keywords
- robotic assistance, arthroplasty, TKA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Southeast Orthopedic SpecialistsResearch network
- Collaborators
- DePuy Orthopaedics, Stryker Orthopaedics
- Study start
- May 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 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 prospective study is to compare two different knee replacement robots. This study will look at patient reported outcome measures and data collected during the operation. The main questions this study aims to answer include:
- Will the patient reported outcomes differ between the two groups?
- Will the intraoperative data differ between the two groups? Participants will undergo total knee replacement with one of the two robots, complete standardized surveys, and have x-rays taken.
Detailed description
The purpose of this study is to compare two different total knee arthroplasty (TKA) robotic assisted (RA) devices. This study will compare patient reported outcome measures prior to and after surgery. These surveys will be used determine if there are differences in patient recovery after TKA depending on the robot used. Radiographs will also be taken and used to compare component positioning. Intraoperative data will be collected to compare OR efficiency of the two systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAKO group | Experimental | Device: Stryker Triathlon with MAKO Robotic-ArmPatients in this arm will receive the Stryker Triathlon implant and the MAKO robotic arm will be used during surgery. |
| VELYS group | Experimental | Device: DePuy Attune with VELYS Robotic-AssistancePatients in this arm will receive the DePuy Attune implant and the VELYS robotic arm will be used during surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must be a candidate for primary TKA (either Stryker Triathlon with MAKO Robotic-Arm or DePuy Attune with VELYS Robotic-Assistance).
- Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of information to the Sponsor.
- Individuals who are willing and able to complete follow up visits, questionnaires, and radiographic evaluations as specified by the study protocol.
- Individuals who are male or non-pregnant female age 18-80 years at time of device implantation.
- Patient has a diagnosis of primary osteoarthritis or degenerative joint disease of the knee.
Key exclusion criteria (13 listed)
- Patient has a Body Mass Index (BMI) > 40.
- Patient has been diagnosed with osteoporosis or displays poor bone quality per the discretion of the investigator.
- Patient has an active or suspected latent infection in affected knee joint. Patient has neuromuscular or neurosensory deficiency.
- Patient is diagnosed with systemic disease or metabolic disorder (e.g., Lupus, Charcot's. Paget's).
- Subject is a woman who is pregnant or lactating.
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 |
|---|---|---|
| Stryker Triathlon with MAKO Robotic-ArmImplant is the Stryker Triathlon total knee arthroplasty and the robotic device is the MAKO robotic-arm | Device | MAKO group |
| DePuy Attune with VELYS Robotic-AssistanceImplant is the DePuy Attune total knee arthroplasty and the robotic device is the VELYS robotic-assistance | Device | VELYS group |
Primary outcome
KSS
Time frame: baseline
Knee Society Score
KSS
Time frame: 6 week
Knee Society Score
KSS
Time frame: 12 week
Knee Society Score
KSS
Time frame: 1 year
Knee Society Score
KOOS JR
Time frame: baseline
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
KOOS JR
Time frame: 6 week
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
KOOS JR
Time frame: 12 week
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
KOOS JR
Time frame: 1 year
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
FJS-12 Knee
Time frame: 6 week
Forgotten Joint Score
FJS-12 Knee
Time frame: 12 week
Forgotten Joint Score
FJS-12 Knee
Time frame: 1 year
Forgotten Joint Score
1 secondary outcome
Operative step time
Time frame: Intraoperative
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 17 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
John Redmond, MD principal investigator
Southeast Orthopedic Specialists
Questions about this trial
What is this clinical trial studying?
A study testing Stryker Triathlon with MAKO Robotic-Arm and DePuy Attune with VELYS Robotic-Assistance in people with Knee Osteoarthritis and Knee Arthritis, run by Southeast Orthopedic Specialists.
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 13 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: opening soon, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Alexis Velez, BS (13214439922, alexisavelez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KSS (time frame: baseline). The study lists 11 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 17 Apr 2024.