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ROSA Robot Used in Total Knee Replacement Post Market Study

NCT ID: NCT03969654

Last Updated: 2024-05-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-09-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic Assisted TKA

Robotic Assisted TKA

Group Type ACTIVE_COMPARATOR

PERSONA Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

Vanguard Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

NexGen Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

Conventional TKA

Conventional TKA

Group Type ACTIVE_COMPARATOR

PERSONA Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

Vanguard Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

NexGen Total Knee

Intervention Type DEVICE

Primary Total Knee Arthroplasty

Interventions

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PERSONA Total Knee

Primary Total Knee Arthroplasty

Intervention Type DEVICE

Vanguard Total Knee

Primary Total Knee Arthroplasty

Intervention Type DEVICE

NexGen Total Knee

Primary Total Knee Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Vail-Summit Orthopaedics

Vail, Colorado, United States

Site Status

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

Westminster, Colorado, United States

Site Status

SIU School of Medicine

Springfield, Illinois, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

OrthoVirginia Chippenham

North Chesterfield, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CMU2018-34K

Identifier Type: -

Identifier Source: org_study_id

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