Osteo Arthritis KneeNCT06189872
Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement
A study testing Attune Cementless in people with Osteo Arthritis Knee, run by Canadian Radiostereometric Analysis Network at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Attune Cementless
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- 21 Oct 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Nova Scotia Health - Orthopedic
Halifax, Nova Scotia, B3H 2E1
London Health Sciences Centre
London, Ontario, N6A 5W9
Orthopaedic Innovation Centre
Winnipeg, Manitoba, R2K 2M9
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Attune Cementless
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attune CementlessDevice
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System | Other | Attune Cruciate Retaining TKA System Receives: Device: Attune Cementless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial baseplate stability
Maximum total point motion (MTPM) migration between 6-12 months and 1-2 year post-operative (mm)
Measured: 6-12 months, 1-2 years post-operative
Secondary outcomes (9)
Femoral component migration
To quantify and characterize femoral component migration up to 24 months after surgery
Measured: 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.
Measured: 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
Measured: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
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".
Measured: Preoperative, 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.
Measured: 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.
Measured: 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)
Measured: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient complications
Evaluate the type and frequency of the complications/adverse events.
Measured: 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).
Measured: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start21 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Turgeon, MD, Principal investigator, Concordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189872
- Sponsor's protocol ID
- ATTUNE2024
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT06189872
- Acronym / sponsor ID
- ATTUNE2024
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System | Other | Device: Attune CementlessAttune Cruciate Retaining TKA System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Active or prior infection of ipsilateral extremity
- Medical condition precluding major surgery
- Inflammatory arthropathy
- Posterior cruciate ligament (PCL) deficiency
- Major coronal plane deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System |
Primary outcome
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)
9 secondary outcomes
Femoral component migration
Time frame: 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
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
European Quality of Life (EQ-5D-5L)
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Oxford Knee Score
Time frame: 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
Satisfaction VAS
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient complications
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Turgeon, MD principal investigator
Concordia Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attune Cementless in people with Osteo Arthritis Knee, run by Canadian Radiostereometric Analysis Network at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibial baseplate stability (time frame: 6-12 months, 1-2 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.