ROSA Total Knee Investigational Testing Authorization Study

Not Applicable

Terminated

• Conditions: Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis
• Interventions: Device: PERSONA Total Knee

• Registration Number: NCT03970629
• Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-30
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-05-31
• Study Start: 2019-06-20
• Primary Completion: 2021-11-23
• Study Completion: 2021-11-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional TKA	PERSONA Total Knee	Conventional TKA
Robotic Assisted TKA	PERSONA Total Knee	Robotic Assisted TKA via ROSA Robot

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score Questionnaire	1 year	Oxford Knee Score
EQ-5D questionnaire	1 year	EQ-5D

Trial Locations

Locations (1)

Hôpital Maisonneuve-Rosemont; 🇨🇦 Montréal, Quebec, Canada