This study is designed to observe clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis of the medial condyle.
The patient-specific Bodycad Unicompartmental Knee System will be implanted on patients with knee osteoarthritis of the medial condyle. The study's hypothesis is that personalized shape and fit of patient-specific knee replacement prosthesis will provide a greater stability and a more natural knee motion in addition to a faster recovery when compared to traditional knee replacement systems. This study is designed to provide a five-years follow-up clinical data on safety and effectiveness of the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
CHU de Quebec - Universite Laval
Québec, Canada
Change from baseline in Knee Society Score (KSS) Objective
Assessment of improvement of clinical outcomes following BUKS implantation using the KSS questionnaire, to evaluate the clinical performance of the articulation
Time frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Assessment of improvement of activity levels following BUKS implantation surgery using the KOOS questionnaire
Time frame: Baseline, post-operative months 3, 6, 12, 24, 36, 48 and 60
Change from baseline in mechanical axis measurement.
Determine by radiographic analysis Varus or Valgus, expected value are +/- 3 degrees
Time frame: Baseline and post operative week 1
Change from baseline of implant position fixation
The anteroposterior and medial lateral slop will be evaluated according to initial planed position. The measured angles will be compared with initial planning. The expected values are +/- 1.5 degree.
Time frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
Change from baseline on bone loss and cementation
Those measurements will be done on x-ray of the patient joint following Knee Society Radiological evaluation form.The tibial component acceptable score for this device will be 2.5 mm. The femoral component acceptable score for this device will be 6 mm.
Time frame: Post operative week 6, months 6, 12, 24, 36, 48 and 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.