At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
In Brief
A clinical study evaluating TruMatch™ Personalized Solutions and Total Knee Arthroplasty with Conventional Instrumentation. for Osteoarthritis, Knee. Completed, enrolled 78 participants across 4 sites.
Detailed Summary
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques. The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.
Study Details
Timeline
Interventions
TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.