ROSA Robot Used in Total Knee Replacement Post Market Study

Rheumatoid Arthritis Clinical Trial

Official title:

ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969654
• Other study ID #: CMU2018-34K
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 22, 2023

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Description:

The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 22, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is a minimum of 18 years of age

• Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling

• Patient has participated in this study-related Informed Consent process

• Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form

• Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

• Patient is currently participating in any other surgical intervention studies or pain management studies

• Patient has underwent contralateral UKA or TKA within the last 18 months

• Hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum)

• Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)

• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Related Conditions & MeSH terms

• Avascular Necrosis of the Femoral Condyle
• Chronic Osteoarthritis
• Knee Pain
• Moderate Varus, Valgus or Flexion Deformities
• Necrosis
• Rheumatoid Arthritis

Intervention

Device:
• PERSONA Total Knee
Primary Total Knee Arthroplasty
• Vanguard Total Knee
Primary Total Knee Arthroplasty
• NexGen Total Knee
Primary Total Knee Arthroplasty

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	OrthoVirginia Chippenham	North Chesterfield	Virginia
United States	SIU School of Medicine	Springfield	Illinois
United States	Vail-Summit Orthopaedics	Vail	Colorado
United States	Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC	Westminster	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Performance	EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score.	Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Primary	Oxford	Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe).	Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Primary	Post-Operative Pain & Satisfaction	Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.	6 weeks, 3 months, and 1 year
Primary	Total Range of Motion	Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop	Pre-op (Baseline), 6 weeks, 3 months, and 1 year