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NCT Number: NCT06189872

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteo Arthritis Knee

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Innovation Centre, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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".

  5. 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.

  6. 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.

  7. 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)

  8. Patient complications

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    Evaluate the type and frequency of the complications/adverse events.

  9. 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).

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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