Porous Baseplate in Total Knee Replacement

Canadian Radiostereometric Analysis Network

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK

Study type: Interventional

Funder types: Other

Identifiers

NCT05226689

B2021:110

Details and patient eligibility

About

This is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Advance Porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.

Full description

All patients will undergo post-operative model-based RSA to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. 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.

Enrollment: 31 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty
• Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
• Aged 21 years or older
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent

Exclusion criteria

• Active or prior infection
• Medical condition precluding major surgery
• Known medical condition limiting patient life expectancy to < 2 years
• Expected to receive contralateral TKA within 1 year
• Inflammatory arthropathy
• Prior patellectomy
• PCL deficiency
• Major (>25 degree) coronal plane deformity
• Bilateral coronal plane deformity requiring simultaneous bilateral TKA
• Bone defects requiring augments, cones and/or stemmed implants
• Body Mass Index greater than 40

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Other group

Description:

Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert.

Treatment:

Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK