ROSA Total Knee Investigational Testing Authorization Study

Zimmer Biomet

Status: Terminated

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

Treatments: Device: PERSONA Total Knee

Study type: Interventional

Funder types: Industry

Identifiers

NCT03970629

CEU2018-46K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Robotic Assisted TKA

Active Comparator group

Description:

Robotic Assisted TKA via ROSA Robot

Treatment:

Device: PERSONA Total Knee

Conventional TKA

Active Comparator group

Description:

Conventional TKA

Treatment:

Device: PERSONA Total Knee