Porous Baseplate in Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05226689
• Other study ID #: B2021:110
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: Canadian Radiostereometric Analysis Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: February 2026
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Radiostereometric Analysis Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total MTPM migration of the baseplate at 1 year	Assessment of the stability of the tibial baseplate (mm)	1 Year
Secondary	Establish the post-operative migration pattern of the patellar and femoral components	Assessment of the migration pattern (mm)	6 Weeks and 6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient complications	Evaluate the type and frequency of the complications/adverse events.	6 Weeks, 6 Months, 1 Year and 2 Years