ROSA Total Knee Investigational Testing Authorization Study

NCT ID: NCT03970629

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2021-11-23

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Assisted TKA

Robotic Assisted TKA via ROSA Robot

Group Type: ACTIVE_COMPARATOR

PERSONA Total Knee

Intervention Type: DEVICE

Primary Total Knee Arthroplasty

Conventional TKA

Conventional TKA

Group Type: ACTIVE_COMPARATOR

PERSONA Total Knee

Intervention Type: DEVICE

Primary Total Knee Arthroplasty

Interventions

PERSONA Total Knee

Primary Total Knee Arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Jaggard

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CEU2018-46K

Identifier Type: -

Identifier Source: org_study_id