RecruitingNot ApplicableNCT06280352

Robotic Assisted vs Custom Made Total Knee Arthroplasty

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

Sponsor

Austrian Workers Compensation Board Styria

Enrollment

120 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis

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.

Eligibility

Min Age: 40 YearsMax Age: 90 Years

Inclusion Criteria8

\- 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 Criteria9

\- 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

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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