Robotic Assisted vs Custom Made Total Knee Arthroplasty (Knieathlon)

Austrian Workers Compensation Board Styria

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Functionally aligned robotically assisted total knee arthroplasty; Device: Custom made Total Knee Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06280352

AUVA_Knieathlon_2024

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 2 patient groups

Custom made Total Knee Arthroplasty

Experimental group

Description:

Implant used is a patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)

Treatment:

Device: Custom made Total Knee Arthroplasty

Functionally aligned robotically assisted total knee arthroplasty

Active Comparator group

Description:

Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker)

Treatment:

Device: Functionally aligned robotically assisted total knee arthroplasty