Abstract
Abstract Detail
Interim results on a prospective, randomised, single-blinded pilot study to compare implant alignment using a patient-matched cutting guide versus a computer-assisted navigation system following total knee arthroplasty.
Purpose of Study
To compare implant alignment using a patient-matched cutting guide (Visionaire) versus a computer-assisted navigation system (CAS) following total knee arthroplasty (TKA).
Description of methods
Ethics approval was sought and granted by the South African Medical Association Research Ethics Committee. Patient consent for participation was obtained. Patients were randomized to TKA using Visionaire or CAS. Mechanical alignment was evaluated pre-operatively and at 3 months with a full leg X-Ray. Operative and post-operative parameters relating to resource utilization were captured. Clinical status according to the Knee Society Clinical Rating System (KSCRS) was assessed pre-operatively and at 3 months. Adverse events were noted. An independent Contract Research Organisation was used to monitor the site.
Summary of results
Ten unique patients were enrolled, of whom 5 were randomized to Visionaire and 5 to CAS. Two patients in the Visionaire group have not yet reached their 3-month assessment. No significant difference in mechanical alignment between the 2 groups at 3 months was observed. The median duration of surgery was significantly shorter for the patient-matched cutting guide group across all assessed parameters (theatre time: 117 versus 150 minutes, p=0.009; operative time: 85 versus 108 minutes, p=0.0088; tourniquet time: 73 versus 99 minutes, p=0.009; and anaesthetist time: 117 versus 150 minutes, p=0.009). No other significant differences in operative or post-operative cost-drivers were noted between the 2 groups. No significant difference in KSCRS scores between the 2 groups at 3 months was observed. Two adverse were reported, one in each group, both unrelated to the medical devices, and both of which have resolved.
Conclusion
While implant alignment appears consistent and comparable in both groups at 3 months, the median duration of surgery was significantly shorter for the Visionaire group.
DISCLOSURE: Assistance and funding was received from Smith & Nephew
