Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA
A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedMarch 20, 2024
March 1, 2024
2.1 years
February 12, 2024
March 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument
accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months
preoperative and postoperative 3months
Secondary Outcomes (4)
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
preoperative and postoperative 3months and 6months
Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument
preoperative and postoperative 3months and 6months
Study Arms (2)
ROSA robotic assist TKA
ACTIVE COMPARATORROSA robotic assist TKA
iassist TKA
ACTIVE COMPARATORiassist TKA
Interventions
total knee replacement with ROSA robotic assist
Eligibility Criteria
You may qualify if:
- primary osteoarthritis knee with indicated for total knee replacement
- age equal or more than 55 years old
You may not qualify if:
- revision surgery
- deformity greater than 15º
- Intra/Post operative complication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, 10700, Thailand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2024
First Posted
March 20, 2024
Study Start
September 17, 2021
Primary Completion
October 22, 2023
Study Completion
February 1, 2024
Last Updated
March 20, 2024
Record last verified: 2024-03