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Completed

NCT Number: NCT03954912

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

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Arthropathy of Knee Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MAKO assisted unicondylar knee arthroplasty

Procedure

MAKO assisted

NAVIO assisted unicondylar knee arthroplasty

Procedure

NAVIO assisted

Primary outcomes

  1. operative time

    Time frame: 1 day

    operative time in minutes the higher value of blood loss is worse outcome

  2. 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

  1. post operative complications

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • Bhumibol Adulyadej Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 17, 2019
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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