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Recruiting NCT06280352

Robotic Assisted vs Custom Made Total Knee Arthroplasty

No phase Interventional Knee Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Custom made Total Knee Arthroplasty, Functionally aligned robotically assisted total knee arthroplasty.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Custom made Total Knee Arthroplasty
    Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)
  • Device Functionally aligned robotically assisted total knee arthroplasty
    Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy

Primary outcome measures

  • Clinical Outcome using the Forgotten Joint Score [Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months]
Secondary outcome measures (9)
  • Clinical outcomes using the Kujala anterior knee pain Score [Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months]
  • Patient satisfaction [Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months]
  • Visual analog pain (VAS) scale [Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months]
  • Surgical and total theatre time [Time frame: Perioperative phase]
  • Opioid use [Time frame: Intraoperative stay]
  • Number of physiotherapy sessions [Time frame: Intraoperative stay]
  • Range of motion measurements (in degrees) [Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months]
  • Radiographic data including radiolucent lines [Time frame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months]
  • Revision rate [Time frame: Minimum 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Austria · 2 centers
  • AUVA UKH Steiermark Standort Graz — Graz
  • AUVA UKH Steiermark Standort Kalwang — Kalwang

Identifiers

NCT: NCT06280352 · AUVA_Knieathlon_2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗