Robotic Assisted vs Custom Made Total Knee Arthroplasty

NCT ID: NCT06280352

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Custom made Total Knee Arthroplasty

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

Group Type EXPERIMENTAL

Custom made Total Knee Arthroplasty

Intervention Type DEVICE

Total knee replacement, patient specific custom made total knee Origin (Symbios, Symbios Orthopédie SA, Avenue des Sciences 1, 1400 Yverdon-les-Bains, Switzerland)

Functionally aligned robotically assisted total knee arthroplasty

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

Group Type ACTIVE_COMPARATOR

Functionally aligned robotically assisted total knee arthroplasty

Intervention Type DEVICE

Total knee replacement, Total Knee Implant Triathlon (Stryker, Kalamazoo, Michigan, U.S.) implanted using MAKO Rio Robotic Arm (Stryker), using functional alignment strategy

Interventions

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Custom 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)

Intervention Type DEVICE

Functionally 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austrian Workers Compensation Board Styria

OTHER

Sponsor Role lead

Responsible Party

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Antonio Klasan

Assistant Professor, MD, PhD, EMBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AUVA UKH Steiermark Standort Graz

Graz, Styria, Austria

Site Status RECRUITING

AUVA UKH Steiermark Standort Kalwang

Kalwang, Styria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Antonio Klasan, MD, PhD, EMBA

Role: CONTACT

+436765085920

Facility Contacts

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Antonio Klasan, MD, PHD, EMBA

Role: primary

Antonio Klasan, MD, PhD, EMBA

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AUVA_Knieathlon_2024

Identifier Type: -

Identifier Source: org_study_id

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