Preoperative Alignment of Total Knee Replacement

Phase 3

Completed

• Conditions: Knee Arthritis

• Registration Number: NCT01242085
• Lead Sponsor: VA Palo Alto Health Care System

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2012-05
• Study Completion: 2013-01
• Results First Submitted: 2013-02-19
• Results First Submitted QC: 2013-03-26
• Status Verified: 2013-05
• Results First Posted: 2013-05-08
• Last Update Submitted: 2013-05-09
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

patients undergoing primary total knee replacement -

Exclusion Criteria

patients who have hardware involving the hip, knee or ankle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Alignment of Knee - Measured Mechanical Axis From CT Data	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 Outcome Measures

Name	Time	Method
Surgical Time	intraoperative surgical time	the difference between the average surgical time will be determined and compared with 95% CI

Trial Locations

Locations (1)

Palo Alto VA HCS; 🇺🇸 Palo Alto, California, United States