NCT05226689

Porous Baseplate in Total Knee Replacement

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-11
• Primary completion: 2025-04-08
• Completion: 2026-07-01
• First posted: 2022-02-07
• Last updated: 2025-12-04

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated device study