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ROSA Robot Used in Total Knee Replacement Post Market Study

NCT03969654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2024-05-03

Study results available
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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

Interventions

DEVICE

PERSONA Total Knee

Primary Total Knee Arthroplasty

DEVICE

Vanguard Total Knee

Primary Total Knee Arthroplasty

DEVICE

NexGen Total Knee

Primary Total Knee Arthroplasty

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hillary Overholser · Zimmer Biomet

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2023-09-22
Completion
2023-09-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03969654 on ClinicalTrials.gov