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

Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Device: Attune Cementless

Detailed Description

All patients will undergo post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize the in vivo migration pattern of the Attune AFFIXIUM Cementless Tibial Baseplate and the Attune POROCOAT Cementless Femoral Component up to 24 months. Patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. Peri-operative adverse events and other clinical complications will be captured as encountered.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Orthopaedic Innovation Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2E1
      • Nova Scotia Health - Orthopedic
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System; Attune Cruciate Retaining TKA System	Device: Attune Cementless; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Quality of Life (EQ-5D-5L)	EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS)	The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily or lower degree of joint awareness.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Femoral component migration	To quantify and characterize femoral component migration up to 24 months after surgery	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Tibial baseplate migration	To quantify and characterize tibial baseplate migration between weight-bearing and non-weight-bearing examinations at 24 months after surgery.	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration	To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Oxford Knee Score	The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Satisfaction VAS	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient complications	Evaluate the type and frequency of the complications/adverse events.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Linear depth (wear) on the tibial insert	To estimate linear depth (wear) on the tibial insert (experimental).	Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Investigators: Principal Investigator: Thomas Turgeon, MD, Concordia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ATTUNE2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes