Back to resultsComparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
Primary Purpose
Osteo Arthritis Knee, Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Arthroplasty, Knee, Robotic-Assisted, VELYS, Accuracy
Eligibility Criteria
Inclusion Criteria:
- Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
- Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
- Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
- Subject is currently not permanently bedridden, as determined by the Investigator
- Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
- Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
- Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery.
Exclusion Criteria:
- The Subject is a woman who is pregnant or lactating.
- Contralateral knee has already been enrolled in this study.
- Subject had a contralateral amputation.
- Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
- Subject has an active local or systemic infection
- Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy)
- Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
- Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Sites / Locations
- Sinai Hospital of Baltimore
- Cuyuna Regional Medical Center
- OrthoCarolina
- Campbell Clinic
- Proliance Orthopedic Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Manual Arm
Robotic-Assisted Arm
Arm Description
Subjects enrolled into this arm of the study will receive an ATTUNE primary total knee replacement that has been implanted using manual instrumentation which is the current standard of care at the participating sites.
Subjects enrolled into this arm will receive an ATTUNE primary total knee replacement that has been implanted with the use of the VELYS Robotic-Assisted Solution device.
Outcomes
Primary Outcome Measures
Accuracy of Long leg Alignment
To determine whether the accuracy to plan of the long leg alignment achieved with the VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed on long-leg X-rays taken at 12 weeks. If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of mechanical axis alignment achieved with VELYS Robotic-Assisted Solution will be conducted.
Secondary Outcome Measures
Type and frequency of adverse events
Evaluate the nature, severity, and frequency of local adverse events associated with the use of the VELYS Robotic-Assisted Solution in total knee arthroplasty during the procedure and within the subsequent 12 weeks, 90 days and 1 year.
Soft tissue damage
Investigators will conduct an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.
Alignment Outliers
The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized
Surgical time
The surgical time (skin to skin), Operative time (wheels in wheels out) and total operative room utilization time will be summarized for both manual and robotic-assisted cohorts.
Accuracy of position of components
Individual component alignment achieved with manual instruments and Robotic-assisted in the frontal and sagittal planes will be summarized, specifically: distal femoral varus-valgus (FM), proximal tibial varus-valgus (TM), femoral component flexion and tibial slope.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04730271
Brief Title
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
Official Title
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty: A Prospective, Non-Randomized Multi-Center Post-market Clinical Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this post-market research study is to gather clinical and radiographic (X-ray) information about total knee replacement surgeries completed with the VELYS Robotic-Assisted Solution and with standard manual instrumentation. The VELYS Robotic-Assisted Solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. The study aims to compare how well the VELYS Robotic-Assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Osteoarthritis
Keywords
Arthroplasty, Knee, Robotic-Assisted, VELYS, Accuracy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
Quantitative analysis of the X-rays will be conducted by a third party who will be blinded to the treatment group.
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Arm
Arm Type
Active Comparator
Arm Description
Subjects enrolled into this arm of the study will receive an ATTUNE primary total knee replacement that has been implanted using manual instrumentation which is the current standard of care at the participating sites.
Arm Title
Robotic-Assisted Arm
Arm Type
Experimental
Arm Description
Subjects enrolled into this arm will receive an ATTUNE primary total knee replacement that has been implanted with the use of the VELYS Robotic-Assisted Solution device.
Intervention Type
Device
Intervention Name(s)
Total Knee Replacement
Intervention Description
Subjects will be implanted with an ATTUNE Primary total knee replacement.
Primary Outcome Measure Information:
Title
Accuracy of Long leg Alignment
Description
To determine whether the accuracy to plan of the long leg alignment achieved with the VELYS Robotic-Assisted Solution is non-inferior to the accuracy to plan of the long leg alignment achieved with the manual ATTUNE Intuition instrumentation. This will be assessed on long-leg X-rays taken at 12 weeks. If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of mechanical axis alignment achieved with VELYS Robotic-Assisted Solution will be conducted.
Time Frame
12 weeks post operative
Secondary Outcome Measure Information:
Title
Type and frequency of adverse events
Description
Evaluate the nature, severity, and frequency of local adverse events associated with the use of the VELYS Robotic-Assisted Solution in total knee arthroplasty during the procedure and within the subsequent 12 weeks, 90 days and 1 year.
Time Frame
Day of operation (intraoperative), 12 weeks, 1 year
Title
Soft tissue damage
Description
Investigators will conduct an intra-operative assessment of the condition and function of key soft tissue structures in both Manual and Robotic-assisted cohorts.
Time Frame
Day of operation (intraoperative)
Title
Alignment Outliers
Description
The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized
Time Frame
12 weeks
Title
Surgical time
Description
The surgical time (skin to skin), Operative time (wheels in wheels out) and total operative room utilization time will be summarized for both manual and robotic-assisted cohorts.
Time Frame
Day of operation (intraoperative)
Title
Accuracy of position of components
Description
Individual component alignment achieved with manual instruments and Robotic-assisted in the frontal and sagittal planes will be summarized, specifically: distal femoral varus-valgus (FM), proximal tibial varus-valgus (TM), femoral component flexion and tibial slope.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Learning curve
Description
To evaluate impact of surgeon learning curve on the VELYS Robotic-Assisted system on accuracy of surgical procedure (assessed via accuracy of long leg alignment to plan), patient reported outcomes, safety, and surgical time.
Time Frame
Day of operation (intraoperative), 12 weeks, 1 year
Title
EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change from baseline
Description
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Scores are derived by a 5 digit code. The higher the number, the better the overall health status of the patient.
Time Frame
12 weeks, 1 year
Title
Forgotten Joint Score (FJS-12)
Description
The Forgotten Joint Scores comprise measures for the assessment of joint-specific patient-reported outcome (PRO). These PRO questionnaires focus on patients' awareness of a specific joint in everyday life. Joint awareness can be simply defined as any unintended perception of a joint. This may include strong sensations like pain, but also includes more subtle feelings like mild stiffness, subjective dysfunction, or any discomfort. The FJS-12 score ranges from 0 to 100, with 0 being the worst score and 100 being the best. A higher score means the patient is better able to forget about the artificial joint in daily life. So, the higher the score, the better the outcome is.
Time Frame
12 weeks, 1 year
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Change from baseline
Description
A knee-specific instrument that derives a score developed to assess the patients' opinion about their knee and associated problems. The maximum total score is 100 indicating no symptoms and the minimum is 0 indicating extreme symptoms.
Time Frame
12 weeks, 1 year
Title
Subject Satisfaction with Knee Replacement
Description
A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10.
Time Frame
12 weeks, 1 year
Title
Pain - Change from baseline
Description
Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10)
Time Frame
12 weeks, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
Subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the Investigator, is a suitable candidate for primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
Subject is currently not permanently bedridden, as determined by the Investigator
Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
Subject's pre-operative alignment is such that (in the opinion of the Investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery.
Exclusion Criteria:
The Subject is a woman who is pregnant or lactating.
Contralateral knee has already been enrolled in this study.
Subject had a contralateral amputation.
Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject has an active local or systemic infection
Subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the Investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy)
Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian J Leslie, PhD
Organizational Affiliation
DePuy Synthes
Official's Role
Study Director
Facility Information:
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Cuyuna Regional Medical Center
City
Crosby
State/Province
Minnesota
ZIP/Postal Code
56441
Country
United States
Facility Name
OrthoCarolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Campbell Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Proliance Orthopedic Associates
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu.
Learn more about this trial
Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty
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