ROSA Total Knee Post Market Study EMEA

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    240
  • sponsor
    Zimmer Biomet
Updated on 23 July 2021

Summary

This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of surgical workflow efficiency, patient pain and function outcome and adverse events data. This study might include Persona, Nexgen and Vanguard product families using the ROSA Total Knee Robotic system or conventional instrumentation. The primary objective is to evaluate the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional instrumentation.

Description

The main purpose of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation. This will be achieved by assessing: planned vs actual component positioning, operative workflow efficiency, patient safety based on incidence and frequency of adverse events, clinical performance measured by overall pain and function, health-related quality of life data and radiographic parameters.

The primary endpoint will report on the accuracy of implant alignment for ROSA Total Knee robotic instrumentation compared to conventional and the secondary endpoints will record surgery time points and evaluate the change of clinical outcomes scores between baseline and post operative follow up for performance and clinical benefits

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric), Avascular Necrosis of the Femoral Condyle, Knee Pain, Chronic Osteoarthritis, Moderate Varus, Valgus or Flexion Deformities, Moderate Varus, Valgus or Flexion Deformities, Moderate Varus, Valgus or Flexion Deformities, Moderate Varus, Valgus or Flexion Deformities, Moderate Varus, Valgus or Flexion Deformities
Treatment Device: Persona Total Knee, Device: NexGen Total Knee, Device: Vanguard Total Knee
Clinical Study IdentifierNCT04338893
SponsorZimmer Biomet
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is a minimum of 18 years of age
Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or 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 EC approved Informed Consent form
Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria

Patient is a minimum of 18 years of age
Independent of study participation, patient is a candidate for commercially available Persona, NexGen, or 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 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 contractures, 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note