Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty
1 other identifier
interventional
33
0 countries
N/A
Brief Summary
This prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
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
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedJune 20, 2019
June 1, 2019
2.6 years
May 13, 2019
June 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
operative time
operative time in minutes the higher value of blood loss is worse outcome
1 day
calculated total blood loss
total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
1 day
Secondary Outcomes (1)
post operative complications
12 months
Study Arms (2)
MAKO robotic assisted UKA
ACTIVE COMPARATORimage base (MAKO) robotic assisted UKA
NAVIO robotic assisted UKA
ACTIVE COMPARATORimageless (NAVIO) robotic assisted UKA
Interventions
Eligibility Criteria
You may qualify if:
- patients were those deemed suitable for unicondylar knee arthroplasty surgery
- patients who could give informed consent
- patients who willing to attend the prescribed follow-up.
You may not qualify if:
- Patients who have medial osteoarthritis knee with following condition:
- Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency).
- Inflammatory arthritis
- A deformity requiring augmentation
- Neurological movement disorders
- pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations
- Patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramathibodi Hospitallead
- Bhumibol Adulyadej Hospitalcollaborator
Related Publications (1)
Leelasestaporn C, Tarnpichprasert T, Arirachakaran A, Kongtharvonskul J. Comparison of 1-year outcomes between MAKO versus NAVIO robot-assisted medial UKA: nonrandomized, prospective, comparative study. Knee Surg Relat Res. 2020 Mar 12;32(1):13. doi: 10.1186/s43019-020-00030-x.
PMID: 32660619DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 17, 2019
Study Start
June 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
June 20, 2019
Record last verified: 2019-06