Clinical trial NCT06189872: Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement
Official title: Radiographic Migration Analysis of the ATTUNE Cementless CR Fixed-Bearing Total Knee Replacement: A Multi-Center, Non-Controlled, Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tibial baseplate stability
timeFrame: 6-12 months, 1-2 years post-operative
Secondary outcomes:
measure: Femoral component migration
timeFrame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Tibial baseplate migration
timeFrame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Equivalency between CT-RSA-measured migration and the gold-standard of RSA-measured migration
timeFrame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: European Quality of Life (EQ-5D-5L)
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Oxford Knee Score
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Forgotten Joint Score (FJS)
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Satisfaction VAS
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Patient complications
timeFrame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
measure: Linear depth (wear) on the tibial insert
timeFrame: Discharge, 6 Weeks, 6 Months, 1 Year and 2 Years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Orthopaedic Innovation Centre
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health - Orthopedic
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Concordia Hospital
name: Thomas Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: