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

Mahidol University

Status: Completed

Conditions: Arthropathy of Knee; Osteoarthritis, Knee

Treatments: Procedure: NAVIO assisted unicondylar knee arthroplasty; Procedure: MAKO assisted unicondylar knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03954912

2/62

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

MAKO robotic assisted UKA

Active Comparator group

Description:

image base (MAKO) robotic assisted UKA

Treatment:

Procedure: MAKO assisted unicondylar knee arthroplasty

NAVIO robotic assisted UKA

Active Comparator group

Description:

imageless (NAVIO) robotic assisted UKA

Treatment:

Procedure: NAVIO assisted unicondylar knee arthroplasty