Knee OsteoarthritisNCT05226689
Porous Baseplate in Total Knee Replacement
A study testing POROUS TIBIA BASEPLATE W/ JRNY LOCK in people with Knee Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- POROUS TIBIA BASEPLATE W/ JRNY LOCK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Apr 2022to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
2 sites in 1 country.
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- POROUS TIBIA BASEPLATE W/ JRNY LOCK
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POROUS TIBIA BASEPLATE W/ JRNY LOCKDevice
Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert
| Study group | Role | What they receive |
|---|---|---|
| POROUS TIBIA BASEPLATE W/ JRNY LOCK | Other | Fixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert. Receives: Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 Months and 1 Year
Secondary outcomes (12)
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)
Measured: 1 Year and 2 Years
Total MTPM migration of the baseplate at 1 year
Assessment of the stability of the tibial baseplate (mm)
Measured: 1 Year
Establish the post-operative migration pattern of the patellar and femoral components
Assessment of the migration pattern (mm)
Measured: 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)
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Preoperative, 6 Months, 1 Year and 2 Years
Patient complications
Evaluate the type and frequency of the complications/adverse events.
Measured: 6 Weeks, 6 Months, 1 Year and 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start11 Apr 2022
- Primary completion8 Apr 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Radiostereometric Analysis Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Naudie, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226689
- Sponsor's protocol ID
- B2021:110
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, RSA Study of the Porous Tibia Baseplate W/Jrny Lock
- ClinicalTrials.gov ID
- NCT05226689
- Acronym / sponsor ID
- B2021:110
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Canadian Radiostereometric Analysis NetworkUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POROUS TIBIA BASEPLATE W/ JRNY LOCK | Other | Device: POROUS TIBIA BASEPLATE W/ JRNY LOCKFixed-bearing POROUS TIBIA BASEPLATE W/ JRNY LOCK and a Legion cruciate-retaining High-Flex or Deep-dish XLPE tibial insert. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POROUS TIBIA BASEPLATE W/ JRNY LOCKFixed-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 |
Primary outcome
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)
12 secondary outcomes
Change between 1- and 2-years post-operative - tibial baseplate stability
Time frame: 1 Year and 2 Years
Total MTPM migration of the baseplate at 1 year
Time frame: 1 Year
Establish the post-operative migration pattern of the patellar and femoral components
Time frame: 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?
Time frame: 1 Year
European Quality of Life (EQ-5D-5L)
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Patient-reported Outcome: Oxford Knee Score
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Forgotten Joint Score (FJS)
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Pain VAS
Time frame: Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years
Satisfaction VAS
Time frame: Preoperative, 6 Months, 1 Year and 2 Years
Patient complications
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Naudie, MD principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POROUS TIBIA BASEPLATE W/ JRNY LOCK in people with Knee Osteoarthritis, run by Canadian Radiostereometric Analysis Network at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between 6 months and 1-year post-operative - tibial baseplate stability (time frame: 6 Months and 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.