Arthroplasties, Knee ReplacementNCT06203756

Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

A study testing Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS and Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision in people with Arthroplasties, Knee Replacement and Revision Arthroplasty, run by Corin at 6 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthroplasty up to 10-year follow up. Read more about this study

Who is it for?: Any age
Conditions the study is for: Arthroplasties, Knee Replacement, Revision Arthroplasty
What is being tested?: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS and Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 713 participants
Where: 6 sitesUnited States
Study dates: 9 Nov 2017to 1 Apr 2040
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient must be a candidate for a primary or revision total knee arthroplasty
Patient is able and willing to sign the informed consent and follow study procedures
Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance

Who cannot join

Patient has a BMI >45.
Significant neurological or musculoskeletal disorders or disease that may interfere with total knee arthroplasty survival, adversely affect gait or weight bearing, (i.e. Paget's disease, Charcot's disease, muscular dystrophy, multiple sclerosis).
The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
Presence of known active metastatic or neoplastic disease.
Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.
Patient has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease).

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Patient has an active infection or joint sepsis.
Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).
Patients with allergies or suspected sensitivity to any patient-contacting component of the implant to be used in the study Has known sensitivity to implants or the materials in the device including but not limited to: Ti, Al, V, Co, Cr, Mo, Ni and Si3N4.).
Patients who are currently on medical leave from their employment due to Worker's Compensation.
Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery (e.g., clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c > 8 mg/dL) or previous history of joint infection).
Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.
Patients who are currently involved in another clinical study with an investigational device.
Patients with current litigation pending related to medical treatment of any sort.
Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Flagstaff Bone and Joint
Flagstaff, Arizona, 86001
Nyu Langone-Long Island
Garden City, New York, 11530
Gundersen Health System
La Crosse, Wisconsin, 54601
Orthopaedics New England
Middlebury, Connecticut, 06762
Oklahoma Sports and Orthopedics Institute
Oklahoma City, Oklahoma, 73114
DeClaire LaMacchia Orthopaedic Institute
Rochester, Michigan, 48307

Other trials in United States

About this study

Official title: Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Read the detailed description

This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up.

Prospective data will be collected for this Post Market Clinical Follow up (PMCF) study and the data will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment on annual basis and support presentations at orthopaedic congresses and/or peer-reviewed publication(s).

Participants will be selected for recruitment into the study from the general population of participants requiring a primary or revision knee-arthroplasty and considered suitable to receive the Apex Knee System.

Conditions: Arthroplasties, Knee Replacement, Revision Arthroplasty
Being tested: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS, Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
Keywords: Robotic-Assisted Total Knee Arthroplasty, Knee Replacement, Knee outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UCDevice
Also called BalanceBot, Apex Knee System, Active Spacer
Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type
Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PSDevice
Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type
Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex RevisionDevice
Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type

Study groups in NCT06203756
Study group	Role	What they receive
Revision Total Knee Arthroplasty	Other	Sensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components. Receives: Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
Primary Total Knee Arthroplasty	Other	Sensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty Receives: Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC; Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS

What is being measured

The primary outcome is the main question the study is designed to answer.

Survivorship
Frequency of device and implant related adverse events and revision surgery to be recorded.
Measured: 10 Years

Secondary outcomes (3)

Change in KOOS from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores and participants opinion about their knee
KOOS ranges from 0 - 100, in which 100 is best.
Measured: from enrolment to 10 years
Change in UCLA from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and University of California Los Angeles (UCLA) activity Scale and measured the participants usual level of activity
UCLA ranges from 0 - 10, in which the higher the score the greater the activity
Measured: from enrolment to 10 years
Change in Promis-10 from baseline to 10 years after surgery
Evaluate impact of participants knee surgery, comparing post-operative Knee Injury and Patient-Reported Outcomes Measurement Information System (PROMIS) and measures the participants physical, mental, and social health.
PROMIS-10 ranges from 1 - 67, in which 67 is best.
Measured: from enrolment to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 20171 Apr 2040

First posted12 Jan 2024
Study start9 Nov 2017
Primary completion1 Jan 2029 (estimated)
Study completion1 Apr 2040 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthroplasties, Knee ReplacementStudies 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: Sequential
Masking: None (open label)
Enrolment: 713 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06203756
Sponsor's protocol ID: CSP-2017-01
Status last verified: May 2025
First submitted: 11 Dec 2023
Last updated: 20 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

All Arthroplasties, Knee Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06203756
Acronym / sponsor ID: CSP-2017-01
Conditions: Arthroplasties, Knee Replacement, Revision Arthroplasty
Keywords: Robotic-Assisted Total Knee Arthroplasty, Knee Replacement, Knee outcomes
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 713 participants (estimated)
Lead sponsor: CorinIndustry (pharma, biotech, devices)
Study start: 9 Nov 2017 (actual)
Primary completion: 1 Jan 2029 (estimated)
Study completion: 1 Apr 2040 (estimated)
First posted: 12 Jan 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.

Detailed description

This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Revision Total Knee Arthroplasty	Other	Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex RevisionSensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components.
Primary Total Knee Arthroplasty	Other	Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC, Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PSSensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patient must be a candidate for a primary or revision total knee arthroplasty
Patient is able and willing to sign the informed consent and follow study procedures
Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance

Key exclusion criteria (15 listed)

Patient has a BMI >45.
Significant neurological or musculoskeletal disorders or disease that may interfere with total knee arthroplasty survival, adversely affect gait or weight bearing, (i.e. Paget's disease, Charcot's disease, muscular dystrophy, multiple sclerosis).
The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
Presence of known active metastatic or neoplastic disease.
Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.

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
Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UCAlso: BalanceBot, Apex Knee System, Active SpacerRobotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type	Device	Primary Total Knee Arthroplasty
Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PSRobotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type	Device	Primary Total Knee Arthroplasty
Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex RevisionRobotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type	Device	Revision Total Knee Arthroplasty

Primary outcome

Survivorship
Time frame: 10 Years
Frequency of device and implant related adverse events and revision surgery to be recorded.

3 secondary outcomes

Change in KOOS from baseline to 10 years after surgery
Time frame: from enrolment to 10 years
Change in UCLA from baseline to 10 years after surgery
Time frame: from enrolment to 10 years
Change in Promis-10 from baseline to 10 years after surgery
Time frame: from enrolment to 10 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 20 May 2025.
Individual participant dataSharing planned: No

Related trials for Arthroplasties, Knee Replacement

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)

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.

Jan A Koenig, MD principal investigator

NYU LANGONE-LONG ISLAND

Jeffrey H DeClaire, MD principal investigator

DeClaire LaMacchia Orthopaedic Institute

Amber Randall, MD principal investigator

Granite Orthopaedics

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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: enrolling by invitation, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

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?

Survivorship (time frame: 10 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06203756.

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 May 2025.