Knee Osteoarthritis
Conditions
Brief summary
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
DEVICECustom 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)
DEVICEFunctionally 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
Sponsors
Austrian Workers Compensation Board Styria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome using the Forgotten Joint Score | 6 weeks, 3 months, 6 months, 12 months, 24 months | Scale 0-100, higher score means better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 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 |
| Visual analog pain (VAS) scale | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months | Scale 0-10, higher score means better outcome |
| Surgical and total theatre time | Perioperative phase | — |
| Opioid use | 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 |
| Clinical outcomes using the Kujala anterior knee pain Score | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months | Scale 0-100, higher score means better outcome |
| Range of motion measurements (in degrees) | preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months | Measurement using a manual goniometer. |
| Radiographic data including radiolucent lines | 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 |
| Revision rate | Minimum 2 years | — |
| Number of physiotherapy sessions | Intraoperative stay | — |
Countries
Austria
Contacts
Primary ContactAntonio Klasan, MD, PhD, EMBA
Outcome results
None listed