Clinical trial NCT06321952: Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA
Official title: A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 64
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument
timeFrame: preoperative and postoperative 3months
Secondary outcomes:
measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
timeFrame: preoperative and postoperative 3months and 6months
measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
timeFrame: preoperative and postoperative 3months and 6months
measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
timeFrame: preoperative and postoperative 3months and 6months
measure: Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
timeFrame: preoperative and postoperative 3months and 6months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References: