ROSA Robot Used in Total Knee Replacement Post Market Study

May 2, 2024 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Vail, Colorado, United States, 81657
        • Vail-Summit Orthopaedics
      • Westminster, Colorado, United States, 80023
        • Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
    • Illinois
      • Springfield, Illinois, United States, 62702
        • SIU School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Virginia
      • North Chesterfield, Virginia, United States, 23225
        • OrthoVirginia Chippenham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Robotic Assisted TKA
Device: PERSONA Total Knee
Primary Total Knee Arthroplasty
Device: Vanguard Total Knee
Primary Total Knee Arthroplasty
Device: NexGen Total Knee
Primary Total Knee Arthroplasty
Active Comparator: Conventional TKA
Device: PERSONA Total Knee
Primary Total Knee Arthroplasty
Device: Vanguard Total Knee
Primary Total Knee Arthroplasty
Device: NexGen Total Knee
Primary Total Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Performance
Time Frame: 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.
Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Oxford
Time Frame: 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).
Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Post-Operative Pain & Satisfaction
Time Frame: 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.
6 weeks, 3 months, and 1 year
Total Range of Motion
Time Frame: 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
Pre-op (Baseline), 6 weeks, 3 months, and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMU2018-34K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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