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

N/AActive Not RecruitingNCT06189872

Canadian Radiostereometric Analysis Network30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteo Arthritis Knee

Interventions

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)

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, Canada

Nova Scotia Health - Orthopedic

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Tibial baseplate stability

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

Time frame: 6-12 months, 1-2 years post-operative

Secondary Outcomes

Femoral component migration

To quantify and characterize femoral component migration up to 24 months after surgery

Time frame: 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.

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

To assess equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration for both tibial and femoral migration

Time frame: 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".

Time frame: 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.

Data from ClinicalTrials.gov

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