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

Canadian Radiostereometric Analysis Network2 sites in 1 country31 target enrollmentApril 11, 2022

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Canadian Radiostereometric Analysis Network
Enrollment: 31
Locations: 2
Primary Endpoint: Change between 6 months and 1-year post-operative - tibial baseplate stability
Status: Active, not recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2022

End Date

July 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Canadian Radiostereometric Analysis Network

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Total MTPM migration of the baseplate at 1 year(1 Year)
Change between 1- and 2-years post-operative - tibial baseplate stability(1 Year and 2 Years)
Establish the post-operative migration pattern of the patellar and femoral components(6 Weeks and 6 Months)
Forgotten Joint Score (FJS)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
University of California at Los Angeles (UCLA) Activity Level scale(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
Satisfaction VAS(Preoperative, 6 Months, 1 Year and 2 Years)
European Quality of Life (EQ-5D-5L)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
Patient-reported Outcome: Oxford Knee Score(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
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)
Pain VAS(Preoperative, 6 Weeks, 6 Months, 1 Year and 2 Years)
Patient complications(6 Weeks, 6 Months, 1 Year and 2 Years)