Porous Baseplate in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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POROUS TIBIA BASEPLATE W/ JRNY LOCK

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

Group Type OTHER

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Intervention Type DEVICE

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

Interventions

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POROUS TIBIA BASEPLATE W/ JRNY LOCK

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes