Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

713 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2040-04-01

Brief Summary

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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.

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Detailed Description

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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

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Arthroplasties, Knee Replacement Revision Arthroplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revision Total Knee Arthroplasty

Sensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components.

Group Type OTHER

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision

Intervention Type DEVICE

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

Primary Total Knee Arthroplasty

Sensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty

Group Type OTHER

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC

Intervention Type DEVICE

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 PS

Intervention Type DEVICE

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

Interventions

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Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC

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

Intervention Type DEVICE

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS

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

Intervention Type DEVICE

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision

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

Intervention Type DEVICE

Other Intervention Names

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BalanceBot, Apex Knee System, Active Spacer

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patient has a BMI \>45.
2. 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).
3. The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
4. Presence of known active metastatic or neoplastic disease.
5. Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.
6. 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).
7. Patient has an active infection or joint sepsis.
8. Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).
9. 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.).
10. Patients who are currently on medical leave from their employment due to Worker's Compensation.
11. 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).
12. 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.
13. Patients who are currently involved in another clinical study with an investigational device.
14. Patients with current litigation pending related to medical treatment of any sort.
15. Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.

Eligible Sex

ALL

Accepts Healthy Volunteers

No