Clinical trial NCT04730271: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Osteoarthritis
Keywords: Arthroplasty
Knee
Robotic-Assisted
VELYS
Accuracy
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2021-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive.
2. 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.
3. 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
4. Subject is currently not permanently bedridden, as determined by the Investigator
5. 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.
6. Subject is able to read and comprehend the Informed Consent Document as well as complete the required PROs in English.
7. 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:

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study.
3. Subject had a contralateral amputation.
4. Previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
5. Subject has an active local or systemic infection
6. 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)
7. Subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity.
8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
9. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

Primary outcomes:
measure: Accuracy of the Hip-Knee-Ankle Angle (HKA) Measured on Long-leg X-rays at 12 Weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Accuracy of the Distal Femoral Varus-valgus Angle Measured on Long Leg X-rays at 12 Weeks.
timeFrame: 12 weeks
measure: Accuracy of the Proximal Tibial Varus-valgus Angle Measured on Long-leg X-rays at 12 Weeks
timeFrame: 12 weeks
measure: Accuracy of Femoral Component Flexion Angle Measured on Lateral X-rays at 12 Weeks
timeFrame: 12 weeks
measure: Accuracy of the Tibial Slope Angle Measured on Lateral X-rays at 12 Weeks
timeFrame: 12 weeks
measure: Type and Frequency of Adverse Events
timeFrame: 12 weeks, 1 year
measure: Soft Tissue Damage
timeFrame: Day of operation (intraoperative)
Other outcomes:
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change From Baseline
timeFrame: 1 year
measure: Forgotten Joint Score (FJS-12)
timeFrame: 12 weeks and 1 year
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) ADL - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptoms - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Subject Satisfaction With Knee Replacement
timeFrame: 12 weeks, 1 year
measure: Pain - Change From Baseline
timeFrame: 12 weeks, 1 year
measure: Learning Curve
timeFrame: 12 Weeks
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Crosby
country: United States
facility: Cuyuna Regional Medical Center
state: Minnesota
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
city: Renton
country: United States
facility: Proliance Orthopedic Associates
state: Washington
Study officials:
affiliation: DePuy Synthes
name: Ian J Leslie, PhD
role: STUDY_DIRECTOR
References: