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NCT Number: NCT03969654

ROSA Robot Used in Total Knee Replacement Post Market Study

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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Key information

Conditions

Knee Pain Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis of the Femoral Condyle Bone Diseases Chronic Osteoarthritis Connective Tissue Diseases Genu Valgum Immune System Diseases Joint Diseases Moderate Varus, Valgus or Flexion Deformities Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vail-Summit Orthopaedics, Vail, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PERSONA Total Knee

Device

Primary Total Knee Arthroplasty

Vanguard Total Knee

Device

Primary Total Knee Arthroplasty

NexGen Total Knee

Device

Primary Total Knee Arthroplasty

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 31, 2019
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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