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

December 3, 2025 updated by: Canadian Radiostereometric Analysis Network

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tibial baseplate stability
Time Frame: 6-12 months, 1-2 years post-operative
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
European Quality of Life (EQ-5D-5L)
Time Frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
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)
Time Frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
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
Time Frame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
To estimate linear depth (wear) on the tibial insert (experimental).
Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Canadian Radiostereometric Analysis Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Turgeon, MD, Concordia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings