ROSA Robot Used in Total Knee Replacement Post Market Study

NCT03969654 | Completed Results FDA Device

• 1 other identifier: CMU2018-34K
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Robotic Assisted TKA

ACTIVE COMPARATOR

Robotic Assisted TKA

Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee

Conventional TKA

ACTIVE COMPARATOR

Conventional TKA

Device: PERSONA Total Knee; Device: Vanguard Total Knee; Device: NexGen Total Knee

Interventions

PERSONA Total Knee DEVICE

Primary Total Knee Arthroplasty

Conventional TKA; Robotic Assisted TKA

Vanguard Total Knee DEVICE

Primary Total Knee Arthroplasty

Conventional TKA; Robotic Assisted TKA

NexGen Total Knee DEVICE

Primary Total Knee Arthroplasty

Conventional TKA; Robotic Assisted TKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Vail-Summit Orthopaedics

Vail, Colorado, 81657, United States

Location

Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC

Westminster, Colorado, 80023, United States

Location

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

OrthoVirginia Chippenham

North Chesterfield, Virginia, 23225, United States

Location

MeSH Terms

Conditions

Genu Valgum; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Zimmer Biomet, Inc.

Clinicaloperations@zimmerbiomet.com

8006136131

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: May 1, 2020
• Primary Completion: September 22, 2023
• Study Completion: September 22, 2023
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)