None listed
Conditions
Brief summary
The study aims to collection information on the performance of the robot system intra-operatively. Enrolment is eligible candidates undergoing primary Total Knee Arthroplasty using a Persona total knee implant system or Vanguard total knee implant system or NexGen total knee implant system. There will be three research centres. One surgeon at each centre. Ten participants will be recruited at each centre.
Interventions
The ROSA Knee System is a stereotaxic instrumentation system for total knee replacement surgery. The system is used by the surgeon to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
Sponsors
Zimmer Biomet Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient qualifies for a primary total knee arthroplasty based on the investigator’s clinical judgement Independent of study participation, patient is a candidate for commercially available Persona Total Knee or Vanguard Total Knee or NexGen Total Knee arthroplasty
Exclusion criteria
Patient has active, local infection or previous intra-articular infection in the affected joint Insufficient bone stock on femoral or tibial surfaces Neuropathic arthroplasty Osteomalacia or any metabolic disorder which may impair bone formation Severe instability secondary to the absence of collateral ligament integrity Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin
Outcome results
None listed