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Comparative Outcomes Between Image-based Versus Imageless Robot-assisted Unicondylar Knee Arthroplasty

Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03954912
Enrollment
33
Registered
2019-05-17
Start date
2015-06-01
Completion date
2018-01-01
Last updated
2019-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Osteoarthritis, Knee

Keywords

MAKO, NAVIO, robotic surgery, UKA, surgical time, KSS, KFS

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

Detailed description

this prospective cohort study was conducted between 1st June 2015 and 1st July 2018 at Bhumibol Adulyadej Hospital, Bangkok, Thailand. A total of 33 medial compartment OA knee patients were randomly allocated to MAKO or NAVIO robotic assisted UKA. The outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

Interventions

PROCEDUREMAKO assisted unicondylar knee arthroplasty

MAKO assisted

PROCEDURENAVIO assisted unicondylar knee arthroplasty

NAVIO assisted

Sponsors

Bhumibol Adulyadej Hospital
CollaboratorOTHER
Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

prospective cohort study

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients who have medial osteoarthritis knee with following condition: 1. Ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency). 2. Inflammatory arthritis 3. A deformity requiring augmentation 4. Neurological movement disorders 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
operative time1 dayoperative time in minutes the higher value of blood loss is worse outcome
calculated total blood loss1 daytotal blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin

Secondary

MeasureTime frameDescription
post operative complications12 monthspost operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026