Comparison of Alignment Achieved Using the VELYS Robotic-Assisted Solution Versus Manual Instrumentation in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04730271
• Other study ID #: DSJ_2019_08
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: January 2024
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 15, 2024
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Total Knee Replacement
Subjects will be implanted with an ATTUNE Primary total knee replacement.

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	OrthoCarolina	Charlotte	North Carolina
United States	Cuyuna Regional Medical Center	Crosby	Minnesota
United States	Campbell Clinic	Germantown	Tennessee
United States	Proliance Orthopedic Associates	Renton	Washington

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Learning curve	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.	Day of operation (intraoperative), 12 weeks, 1 year
Other	EuroQol 5-Dimension 5-Level (EQ-5D-5L) - Change from baseline	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.	12 weeks, 1 year
Other	Forgotten Joint Score (FJS-12)	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.	12 weeks, 1 year
Other	Knee Injury and Osteoarthritis Outcome Score (KOOS) - Change from baseline	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.	12 weeks, 1 year
Other	Subject Satisfaction with Knee Replacement	A single patient reported question that asks the patient to score their level of satisfaction with their knee from 0-10.	12 weeks, 1 year
Other	Pain - Change from baseline	Subjects are asked how much knee pain they have had in the last week while resting (0-10) and during activity (0-10)	12 weeks, 1 year
Primary	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.	12 weeks post operative
Secondary	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.	Day of operation (intraoperative), 12 weeks, 1 year
Secondary	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.	Day of operation (intraoperative)
Secondary	Alignment Outliers	The alignment outliers (>3 degrees outside of plan) in both Manual and Robotics cohorts will be summarized	12 weeks
Secondary	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.	Day of operation (intraoperative)
Secondary	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.	12 weeks