ROSA Robot Used in Total Knee Replacement Post Market Study

Not Applicable

Completed

• Conditions: Knee Pain; Avascular Necrosis of the Femoral Condyle; Chronic Osteoarthritis; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis
• Interventions: Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee

• Registration Number: NCT03969654
• Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2020-05-01
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Results First Submitted: 2024-02-26
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Results First Posted: 2024-05-03
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Assisted TKA	PERSONA Total Knee	Robotic Assisted TKA
Conventional TKA	PERSONA Total Knee	Conventional TKA
Robotic Assisted TKA	Vanguard Total Knee	Robotic Assisted TKA
Robotic Assisted TKA	NexGen Total Knee	Robotic Assisted TKA
Conventional TKA	Vanguard Total Knee	Conventional TKA
Conventional TKA	NexGen Total Knee	Conventional TKA

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain & Satisfaction	6 weeks, 3 months, and 1 year	Post-Operative Pain \& Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied.
Clinical Performance	Pre-op (Baseline), 6 weeks, 3 months, and 1 year	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.
Total Range of Motion	Pre-op (Baseline), 6 weeks, 3 months, and 1 year	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
Oxford	Pre-op (Baseline), 6 weeks, 3 months, and 1 year	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).

Trial Locations

Locations (5)

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, United States