Preoperative Alignment of Total Knee Replacement

Knee Arthritis Clinical Trial

Official title:

Alignment of Total Knee Components Using Standard or Custom Instrumentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242085
• Other study ID #: 04061991
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2010
• Last updated: May 9, 2013
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:patients undergoing primary total knee replacement -

Exclusion Criteria:patients who have hardware involving the hip, knee or ankle

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthritis

Intervention

Procedure:
• trumatch group
these patient will have CT based customized knee instruments used for surgery
• control group
these patients will have standard instrumentation used for for knee replacement

Locations

Country	Name	City	State
United States	Palo Alto VA HCS	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alignment of Knee - Measured Mechanical Axis From CT Data	the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment	postoperatively - CT done within 1 week of surgery	No
Secondary	Surgical Time	the difference between the average surgical time will be determined and compared with 95% CI	intraoperative surgical time	No