ROSA Total Knee Investigational Testing Authorization Study

Rheumatoid Arthritis Clinical Trial

Official title:

ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03970629
• Other study ID #: CEU2018-46K
• Status: Terminated
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: November 23, 2021

Study information

• Verified date: May 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single-center 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 Total Knee components using the ROSA Total Knee Robotic System or conventional instrumentation.

Description:

The primary objective of this study is to collect and compare clinical outcomes and surgical data using the ROSA Total Knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty.

The assessments will include: Planned vs actual component positioning; Workflow efficiency; Patient safety based on incidence and frequency of adverse events; Clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patient is a minimum of 18 years of age

2. Pre-op component positioning and sizing plan prior to surgery

3. Independent of study participation, patient is a candidate for primary TKA using the commercially available Persona knee components implanted in accordance with product labeling

4. Patient has participated in this study-related Informed Consent process

5. Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form

6. Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

1. Patient is currently participating in any other surgical intervention studies or pain management studies

2. Patient has underwent contralateral UKA or TKA within the last 18 months

3. 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)

4. Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)

5. Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

6. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Related Conditions & MeSH terms

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

Intervention

Device:
• PERSONA Total Knee
Primary Total Knee Arthroplasty

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EQ-5D questionnaire	EQ-5D	1 year
Primary	Oxford Knee Score Questionnaire	Oxford Knee Score	1 year