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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2018-01-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee Arthropathy of Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MAKO robotic assisted UKA

image base (MAKO) robotic assisted UKA

Group Type ACTIVE_COMPARATOR

MAKO assisted unicondylar knee arthroplasty

Intervention Type PROCEDURE

MAKO assisted

NAVIO robotic assisted UKA

imageless (NAVIO) robotic assisted UKA

Group Type ACTIVE_COMPARATOR

NAVIO assisted unicondylar knee arthroplasty

Intervention Type PROCEDURE

NAVIO assisted

Interventions

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MAKO assisted unicondylar knee arthroplasty

MAKO assisted

Intervention Type PROCEDURE

NAVIO assisted unicondylar knee arthroplasty

NAVIO assisted

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No