Porous Baseplate in Total Knee Replacement

A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3S8
      • Concordia Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change between 6 months and 1-year post-operative - tibial baseplate stability	Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)	6 Months and 1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change between 1- and 2-years post-operative - tibial baseplate stability	Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)	1 Year and 2 Years
Total MTPM migration of the baseplate at 1 year	Assessment of the stability of the tibial baseplate (mm)	1 Year
Establish the post-operative migration pattern of the patellar and femoral components	Assessment of the migration pattern (mm)	6 Weeks and 6 Months
What is the magnitude of baseplate displacement that results from patient weight-bearing (single leg stance) versus non-weight-bearing at 1-year post-operation?	Assessment of the baseplate displacement differences between standing and supine RSA (mm)	1 Year
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".	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient-reported Outcome: 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.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS)	The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily or lower degree of joint awareness.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)	The KOOS JR. was a participant completed questionnaire that consists of 7 questions from 3 subscales: stiffness (1 question), pain (4 questions), and function in daily living (2 questions). Standardized answer options are given (5 Likert boxes) and each question was assigned a score from none (0) to extreme (4).	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale	Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Pain VAS	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)	Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Satisfaction VAS	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)	Preoperative, 6 Months, 1 Year and 2 Years
Patient complications	Evaluate the type and frequency of the complications/adverse events.	6 Weeks, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Investigators: Principal Investigator: Douglas Naudie, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): April 8, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: B2021:110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes