Clinical trial NCT06280352: Robotic Assisted vs Custom Made Total Knee Arthroplasty
Official title: Prospective Randomized Controlled Trial of Functionally Aligned Robotically Assisted Total Knee Arthroplasty vs Patient Specific Custom Made Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Austrian Workers Compensation Board Styria
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical Outcome using the Forgotten Joint Score
timeFrame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Clinical outcomes using the Kujala anterior knee pain Score
timeFrame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Patient satisfaction
timeFrame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Visual analog pain (VAS) scale
timeFrame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Surgical and total theatre time
timeFrame: Perioperative phase
measure: Opioid use
timeFrame: Intraoperative stay
measure: Number of physiotherapy sessions
timeFrame: Intraoperative stay
measure: Range of motion measurements (in degrees)
timeFrame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Radiographic data including radiolucent lines
timeFrame: preoperatively, 6 weeks, 3 months, 6 months, 12 months, 24 months
measure: Revision rate
timeFrame: Minimum 2 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: AUVA UKH Steiermark Standort Graz
state: Styria
city: Kalwang
country: Austria
facility: AUVA UKH Steiermark Standort Kalwang
state: Styria
Study officials:
References: