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NCT03954912 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03954912
Other study ID # 2/62
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date January 1, 2018

Study information
Verified date June 2019
Source Ramathibodi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• MAKO assisted unicondylar knee arthroplasty
MAKO assisted
• NAVIO assisted unicondylar knee arthroplasty
NAVIO assisted

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ramathibodi Hospital Bhumibol Adulyadej Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary operative time operative time in minutes the higher value of blood loss is worse outcome 1 day
Primary 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 post operative complications post operative complications included infection, wound complication, stiffness and revision. the higher number of post operative outcome is the worse outcomes 12 months
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