Preoperative Alignment of Total Knee Replacement

NCT ID: NCT01242085

Last Updated: 2013-05-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

control group will have standard instrumentation of their knee replacement

Group Type ACTIVE_COMPARATOR

control group

Intervention Type PROCEDURE

these patients will have standard instrumentation used for for knee replacement

trumatch group

the trumatch patient will have custom instruments made from preop CT scans

Group Type EXPERIMENTAL

trumatch group

Intervention Type PROCEDURE

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

Interventions

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trumatch group

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

Intervention Type PROCEDURE

control group

these patients will have standard instrumentation used for for knee replacement

Intervention Type PROCEDURE

Other Intervention Names

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trumatch CPI Depuy knee instruments

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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steven woolson

staff surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Palo Alto VA HCS

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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04061991

Identifier Type: -

Identifier Source: org_study_id

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