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Evaluation of the TruMatch® System in Knee Prosthetic Surgery

NCT01876654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-05-12

No results posted yet for this study

Summary

Patient specific instrumentation is an alternative to conventional intra- and extra-medullary guides to perform the femoral and tibial cuts in total knee replacement (TKR).

This instrumentation could provide a better alignment of a TKR, reduce blood losses and operative time, and improve clinical outcomes.

The primary goal of this study is to compare the femorotibial mismatch angle of two groups of patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional Attune® instrumentation (DePuy Johnson \& Johnson, Warsaw, Indiana), versus patient undergoing TKR with the TruMatch® (DePuy Johnson \& Johnson, Warsaw, Indiana) cutting guide.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

TruMatch® patient specific cutting guide

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Pietro S. Randelli, MD · University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Italy

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 NCT01876654 on ClinicalTrials.gov