Robotic Assisted vs Custom Made Total Knee Arthroplasty

NCT06280352 | Recruiting FDA Device

• 1 other identifier: AUVA_Knieathlon_2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome using the Forgotten Joint Score

  Scale 0-100, higher score means better outcome

  6 weeks, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes (9)

• 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

• Surgical and total theatre time

  Perioperative phase

• Opioid use

  Intraoperative stay

Study Arms (2)

Custom made Total Knee Arthroplasty

EXPERIMENTAL

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

Device: Custom made Total Knee Arthroplasty

Functionally aligned robotically assisted total knee arthroplasty

ACTIVE COMPARATOR

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

Device: Functionally aligned robotically assisted total knee arthroplasty

Interventions

Custom made Total Knee Arthroplasty DEVICE

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

Custom made Total Knee Arthroplasty

Functionally aligned robotically assisted total knee arthroplasty DEVICE

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

Functionally aligned robotically assisted total knee arthroplasty

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Austrian Workers Compensation Board Styria: lead

Study Sites (2)

AUVA UKH Steiermark Standort Graz

Graz, Styria, 8020, Austria

RECRUITING

AUVA UKH Steiermark Standort Kalwang

Kalwang, Styria, 8775, Austria

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Antonio Klasan, MD, PhD, EMBA

CONTACT

+436765085920; klasan.antonio@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD, PhD, EMBA

Model Details: Randomized

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

AU (2)