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OpenTrials
Completed

NCT Number: NCT01242085

Preoperative Alignment of Total Knee Replacement

The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.

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Key information

Conditions

Knee Arthritis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Palo Alto VA HCS

Palo Alto, California, 94304, United States

About this study

Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients undergoing primary total knee replacement -

Exclusion criteria

patients who have hardware involving the hip, knee or ankle

-

Treatment and study plan

trumatch group

Procedure

these patient will have CT based customized knee instruments used for surgery

Other names: trumatch CPI

Control Group

Procedure

these patients will have standard instrumentation used for for knee replacement

Other names: Depuy knee instruments

Primary outcomes

  1. Alignment of Knee - Measured Mechanical Axis From CT Data

    Time frame: postoperatively - CT done within 1 week of surgery

    the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment

Secondary outcomes

  1. Surgical Time

    Time frame: intraoperative surgical time

    the difference between the average surgical time will be determined and compared with 95% CI

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Collaborators

  • DePuy Orthopaedics

Registry information

Official study title

Alignment of Total Knee Components Using Standard or Custom Instrumentation

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Nov 16, 2010
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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