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NCT Number: NCT06280352

Robotic Assisted vs Custom Made Total Knee Arthroplasty

The goal of this clinical trial is to compare Robotic Assisted, functionally aligned vs Custom Made Total Knee Arthroplasty in patients with knee osteoarthritis. The main questions it aims to answer are:

* Which implant/philosophy yields better clinical outcomes? * Which implant/philosophy yields better satisfaction? * Which system is more OR efficient? Participants will be followed for 2 years postoperatively.

Recruiting

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUVA UKH Steiermark Standort Graz, Graz, Styria, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - The patient is a male or non-pregnant female between the ages of 40 and 90 years
  • The patient requires a primary total knee replacement
  • Patient is deemed appropriate for a cruciate retaining knee replacement
  • The patient has a primary diagnosis of osteoarthritis (OA)
  • The patient has intact collateral ligaments
  • The patient is able to undergo CT scanning of the affected limb
  • The patient has signed the study specific, ethics-approved, informed consent document
  • The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations

Exclusion criteria

  • - The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint
  • Patient has had a previous osteotomy around the knee
  • The patient is morbidly obese (BMI > 41)
  • The patient has a deformity which will require the use of stems, wedges or augments
  • The patient has a varus deformity ≥ 15°
  • The patient has a valgus deformity >3°
  • The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device
  • The patient is unable to speak German
  • The patient is pregnant

Treatment and study plan

Custom made Total Knee Arthroplasty

Device

Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)

Functionally aligned robotically assisted total knee arthroplasty

Device

Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy

Primary outcomes

  1. Clinical Outcome using the Forgotten Joint Score

    Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months

    Scale 0-100, higher score means better outcome

Secondary outcomes

  1. Clinical outcomes using the Kujala anterior knee pain Score

    Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months

    Scale 0-100, higher score means better outcome

  2. Patient satisfaction

    Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months

    Question "Are you satisfied with the outcome of your operation" using a Likert scale with 5 points: 1- very dissatisfied, 2-dissatisfied, 3 - neither satisfied nor dissatisfied, 4 - satisfied, 5 - very satisfied

  3. Visual analog pain (VAS) scale

    Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months

    Scale 0-10, higher score means better outcome

  4. Surgical and total theatre time

    Time frame: Perioperative phase

  5. Opioid use

    Time frame: Intraoperative stay

    Total dosage of opioids, registered in Austria for pain management after knee replacement, administered to the patient during in-hospital stay: Hydromorphon, Tramadol, Oxycodone/Naloxon as well as number of ampules of Piritramid

  6. Number of physiotherapy sessions

    Time frame: Intraoperative stay

  7. Range of motion measurements (in degrees)

    Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months

    Measurement using a manual goniometer.

  8. Radiographic data including radiolucent lines

    Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months

    Incidence of radiolucent lines >1 mm, with zones defined according to the New Knee Society Classification

  9. Revision rate

    Time frame: Minimum 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Klasan, MD, PhD, EMBA

CONTACT

[email protected]

+436765085920

Sponsors and collaborators

Lead sponsor

Austrian Workers Compensation Board Styria

Other

Registry information

Official study title

Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty

Acronym: Knieathlon

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Jan 28, 2025

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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