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Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

NCT01108237 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-10-24

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

OTHER

TruMatch™ Personalized Solutions

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.

DEVICE

Total Knee Arthroplasty with Conventional Instrumentation.

Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Sponsors & Collaborators

  • DePuy Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Saleem Himden, BA · DePuy Orthopaedics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2011-03-01
Completion
2011-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01108237 on ClinicalTrials.gov