Clinical trial NCT03969654: ROSA Robot Used in Total Knee Replacement Post Market Study
Official title: ROSA Total Knee Post Market Study: Prospective Multicenter U.S. Study of the ROSA Total Knee System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain
Chronic Osteoarthritis
Avascular Necrosis of the Femoral Condyle
Moderate Varus, Valgus or Flexion Deformities
Rheumatoid Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter 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, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.

Detailed description: The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Eligibility criteria: Inclusion Criteria:

* Patient is a minimum of 18 years of age
* Independent of study participation, patient is a candidate for commercially available Persona, NexGen, and Vanguard knee components implanted in accordance with product labeling
* Patient has participated in this study-related Informed Consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form
* Patient is willing and able to complete scheduled study procedures and follow-up evaluations

Exclusion Criteria:

* Patient is currently participating in any other surgical intervention studies or pain management studies
* Patient has underwent contralateral UKA or TKA within the last 18 months
* 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)
* Hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation)
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
* Patient has previously received partial or total knee arthroplasty for the ipsilateral knee

Primary outcomes:
measure: Clinical Performance
timeFrame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
measure: Oxford
timeFrame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
measure: Post-Operative Pain & Satisfaction
timeFrame: 6 weeks, 3 months, and 1 year
measure: Total Range of Motion
timeFrame: Pre-op (Baseline), 6 weeks, 3 months, and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vail
country: United States
facility: Vail-Summit Orthopaedics
state: Colorado
city: Westminster
country: United States
facility: Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC
state: Colorado
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: North Chesterfield
country: United States
facility: OrthoVirginia Chippenham
state: Virginia
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: