NCT06280352 Robotic Assisted vs Custom Made Total Knee Arthroplasty
| NCT ID | NCT06280352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Austrian Workers Compensation Board Styria |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-03-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06280352 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 90 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06280352 currently recruiting?
Yes, NCT06280352 is actively recruiting participants. Contact the research team at klasan.antonio@me.com for enrollment information.
Where is the NCT06280352 trial being conducted?
This trial is being conducted at Graz, Austria, Kalwang, Austria.
Who is sponsoring the NCT06280352 clinical trial?
NCT06280352 is sponsored by Austrian Workers Compensation Board Styria. The trial plans to enroll 120 participants.