NCT03416946

Custom Cutting Block Instrument vs Regular Instrumentation Total Knee Replacement (TKR)

A Double-blinded, Randomized, Controlled Trial of Total Knee Replacement Using Custom Cutting Block Instrument vs Regular Instrumentation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Orthopaedic Innovation Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.

Detailed description

This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Visionaire	Custom cutting block using MRI to create patient specific instrumentations
OTHER	Traditional	Traditional cutting method

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2018-01-31
• Last updated: 2021-10-04
• Results posted: 2021-10-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study