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

Austrian Workers Compensation Board Styria2 sites in 1 country120 target enrollmentMarch 1, 2024

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Austrian Workers Compensation Board Styria
Enrollment: 120
Locations: 2
Primary Endpoint: Clinical Outcome using the Forgotten Joint Score
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

April 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Austrian Workers Compensation Board Styria

Responsible Party

Principal Investigator

Antonio Klasan

Assistant Professor, MD, PhD, EMBA

Austrian Workers Compensation Board Styria

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

Outcomes

Primary Outcomes

Clinical Outcome using the Forgotten Joint Score

Time Frame: 6 weeks, 3 months, 6 months, 12 months, 24 months

Scale 0-100, higher score means better outcome

Secondary Outcomes

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