Comparative Outcomes Between Image-based (MAKO) Versus Imageless NAVIO Robot-assisted Unicondylar Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ramathibodi Hospital
- Enrollment
- 33
- Primary Endpoint
- operative time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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:
- •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.
Outcomes
Primary Outcomes
operative time
Time Frame: 1 day
operative time in minutes the higher value of blood loss is worse outcome
calculated total blood loss
Time Frame: 1 day
total blood loss which was calculated using a formula based on patient blood volume and a decrease in hemoglobin
Secondary Outcomes
- post operative complications(12 months)
Investigators
Jatupon Kongtharvonskul
principle investigator
Ramathibodi Hospital