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

NCT ID: NCT06189872

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2027-06-30

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System

Attune Cruciate Retaining TKA System

Group Type: OTHER

Attune Cementless

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Radiostereometric Analysis Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Turgeon, MD

Role: PRINCIPAL_INVESTIGATOR

Concordia Hospital

Locations

Orthopaedic Innovation Centre

Winnipeg, Manitoba, Canada

Nova Scotia Health - Orthopedic

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

ATTUNE2024

Identifier Type: -

Identifier Source: org_study_id