Knee Arthropathy
Conditions
Brief summary
A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
Detailed description
Introduction: Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty. Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.
Interventions
DEVICEROSA robotic assist TKA
total knee replacement with ROSA robotic assist
PROCEDUREiassist TKA
total knee replacement with iassist
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* primary osteoarthritis knee with indicated for total knee replacement * age equal or more than 55 years old
Exclusion criteria
* revision surgery * deformity greater than 15º * Intra/Post operative complication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument | preoperative and postoperative 3months | accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument | preoperative and postoperative 3months and 6months | functional outcomes (KOOS score) score 0-100 in each domain of 4 domains 0=worst, 100=good |
Countries
Thailand
Outcome results
None listed