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Completed

NCT Number: NCT06321952

Comparison of Accuracy and Functional Outcome Between Robotic and Gyroscopic Assisted Surgery in Primary TKA

A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

About this study

Introduction: Primary total knee arthroplasty is considered the gold standard treatment for end-stage osteoarthritis of the knee. The primary objective of this surgical procedure is to restore mechanical alignment. At Siriraj Hospital, we employ technology to enhance the accuracy of our surgical procedures. The purpose of this study is to compare the accuracy of robotic-assisted surgery (ROSA) and gyroscope-based surgery in primary total knee arthroplasty.

Methods: A randomized controlled trial was conducted with 72 participants who had moderate knee osteoarthritis (Kellgren and Lawrence grade 2-3). The patients were randomly assigned to either the robotic-assisted or gyroscopic-assisted group. Baseline characteristics, including age, body mass index, length of stay, and estimated blood loss, were recorded. The primary outcome measure was the accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months. Secondary outcomes included functional outcomes (KOOS, Oxford knee score, EQ-5D-5L, range of motion) assessed preoperatively and postoperatively at 3 months, as well as at 6 months postoperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • primary osteoarthritis knee with indicated for total knee replacement
  • age equal or more than 55 years old

Exclusion criteria

  • revision surgery
  • deformity greater than 15º
  • Intra/Post operative complication

Treatment and study plan

ROSA robotic assist TKA

Device

total knee replacement with ROSA robotic assist

Other names: iassist TKA

iassist TKA

Procedure

total knee replacement with iassist

Primary outcomes

  1. accuracy of Robotic Assisted Surgery and Gyroscopic Based Instrument

    Time frame: preoperative and postoperative 3months

    accuracy of the hip knee angle, measured by scannogram film preoperatively and postoperatively at 3 months

Secondary outcomes

  1. Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument

    Time frame: preoperative and postoperative 3months and 6months

    functional outcomes (KOOS score) score 0-100 in each domain of 4 domains 0=worst, 100=good

  2. Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument

    Time frame: preoperative and postoperative 3months and 6months

    functional outcomes (Oxford knee score) score 0-48 0=worst, 48=good

  3. Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument

    Time frame: preoperative and postoperative 3months and 6months

    functional outcomes (EQ-5D-5L) score 5-25, score5=good, 25=worst

  4. Functional Outcome of Robotic Assisted Surgery and Gyroscopic Based Instrument

    Time frame: preoperative and postoperative 3months and 6months

    functional outcomes (range of motion)

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Comparison of Accuracy and Functional Outcome Between Robotic Assisted Surgery and Gyroscopic Based Instrument in Primary Total Knee Arthroplasty

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

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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