None listed
Conditions
Brief summary
Robot assisted knee arthroplasty is a relatively recent development intended to assist the surgeons in achieving accurate bone cuts and predictable implant positioning. This study is investigating the accuracy of robotic surgery in partial knee arthroplasty. This will include the assessment of the intraoperative planned vs. actual component positioning. Also investigated will be the evaluation of safety and efficacy of this system including the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.
Interventions
Partial Knee Arthoplasty. Robot-assisted partial knee arthroplasty procedure is anticipated to take 1 hour to complete. A specialist trained orthopaedic surgeon will perform the surgery using the ROSA robot. Data logs from the robot will be used to assess the fidelity to the intervention, along with imaging following the procedure. In addition, patient reported outcomes and clinical assessments will occur at multiple timepoints following the surgery.
All surgeons will be experienced with the pr
Partial Knee Arthoplasty. Robot-assisted partial knee arthroplasty procedure is anticipated to take 1 hour to complete. A specialist trained orthopaedic surgeon will perform the surgery using the ROSA robot. Data logs from the robot will be used to assess the fidelity to the intervention, along with imaging following the procedure. In addition, patient reported outcomes and clinical assessments will occur at multiple timepoints following the surgery. All surgeons will be experienced with the prosthesis, and will have 2 hours implantation cadaveric training session led by the Sponsor on the robotic procedure and specific instrumentation required.
Sponsors
Zimmer Biomet
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Body mass index greater than or equal to 40 kg/m2 2) Patient qualifies for primary UKA for isolated medial compartment osteoarthritis based on investigator’s clinical judgement and has an intact ACL. 3) Independent of study participation, patient is a candidate and meets the indications and contraindications for UKA of the medial compartment with the Persona® partial knee system.
Exclusion criteria
1) Infection, Sepsis, Osteomyelitis 2) Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis. 3) Prior ACL repair. 4) Varus/Valgus deformity greater than 15 degrees. 5) Orthopaedic procedure or pain management study of any joint within the last or next 6 months
Outcome results
None listed