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NCT Number: NCT05226689

Porous Baseplate in Total Knee Replacement

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Device

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

Primary outcomes

  1. Change between 6 months and 1-year post-operative - tibial baseplate stability

    Time frame: 6 Months and 1 Year

    Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 6 months and 1 year post-operative (mm)

Secondary outcomes

  1. Change between 1- and 2-years post-operative - tibial baseplate stability

    Time frame: 1 Year and 2 Years

    Maximum total point motion (MTPM) migration of the POROUS TIBIA BASEPLATE W/ JRNY LOCK between 1 year and 2 years post-operative (mm)

  2. Total MTPM migration of the baseplate at 1 year

    Time frame: 1 Year

    Assessment of the stability of the tibial baseplate (mm)

  3. Establish the post-operative migration pattern of the patellar and femoral components

    Time frame: 6 Weeks and 6 Months

    Assessment of the migration pattern (mm)

  4. 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?

    Time frame: 1 Year

    Assessment of the baseplate displacement differences between standing and supine RSA (mm)

  5. European Quality of Life (EQ-5D-5L)

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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".

  6. Patient-reported Outcome: Oxford Knee Score

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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.

  7. Forgotten Joint Score (FJS)

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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.

  8. Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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).

  9. University of California at Los Angeles (UCLA) Activity Level scale

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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.

  10. Pain VAS

    Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

    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)

  11. Satisfaction VAS

    Time frame: Preoperative, 6 Months, 1 Year and 2 Years

    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)

  12. Patient complications

    Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years

    Evaluate the type and frequency of the complications/adverse events.

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 7, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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