Clinical trial NCT03970629: ROSA Total Knee Investigational Testing Authorization Study
Official title: ROSA Total Knee Investigational Testing Authorization Study: Prospective Single Center Study of the ROSA Total Knee System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Pain
Chronic Osteoarthritis
Avascular Necrosis of Femoral Condyle
Moderate Varus, Valgus or Flexion Deformities
Rheumatoid Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: EQ-5D questionnaire
timeFrame: 1 year
measure: Oxford Knee Score Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Zimmer Biomet
name: Charles Jaggard
role: STUDY_DIRECTOR
References: