Porous Baseplate in Total Knee Replacement

NCT05226689 | Active Not Recruiting FDA Device

• 1 other identifier: B2021:110
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

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

  1 Year and 2 Years

• Total MTPM migration of the baseplate at 1 year

  1 Year

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

  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?

  1 Year

• European Quality of Life (EQ-5D-5L)

  Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years

Study Arms (1)

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.

Device: POROUS TIBIA BASEPLATE W/ JRNY LOCK

Interventions

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

POROUS TIBIA BASEPLATE W/ JRNY LOCK

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead

Study Sites (2)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Douglas Naudie, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: February 7, 2022
• Study Start: April 11, 2022
• Primary Completion: April 8, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

CA (2)