Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement

NCT06189872 | Active Not Recruiting FDA Device

• 1 other identifier: ATTUNE2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

• Tibial baseplate stability

  Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm)

  6-12 months, 1-2 years post-operative

Secondary Outcomes (9)

• Femoral component migration

  Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years

• Tibial baseplate migration

  Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years

• Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration

  Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years

• European Quality of Life (EQ-5D-5L)

  Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

• Oxford Knee Score

  Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

Study Arms (1)

Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System

OTHER

Attune Cruciate Retaining TKA System

Device: Attune Cementless

Interventions

Attune Cementless DEVICE

* Attune AFFIXIUM Cementless Tibial Baseplate, Fixed Bearing * Attune POROCOAT Cementless Femoral Component, Cruciate Retaining * Attune AOX Antioxidant Polyethylene Tibial Insert, Cruciate Retaining * Attune AOX Patellar Button, Domed or Medialized Dome, Cemented or Cementless (surgeon preference for resurfacing)

Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
• Patients aged 21 years or older
• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent

You may not qualify if:

• Active or prior infection of ipsilateral extremity
• Medical condition precluding major surgery
• Inflammatory arthropathy
• Posterior cruciate ligament (PCL) deficiency
• Major coronal plane deformity
• Conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use
• Bone defects requiring augments, cones and/or stemmed implants

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead

Study Sites (3)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

Location

Nova Scotia Health - Orthopedic

Halifax, Nova Scotia, B3H 2E1, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Officials

• Thomas Turgeon, MD

  Concordia Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

CA (3)