Knee Arthroplasty Performed With Conventional and Customized Instrumentation

Completed · Phase 4

Conditions studied: Knee Arthritis

In brief

The main purpose of this study is to determine whether the surgical time required for primary total knee arthroplasty is significantly less when performed with Customized Patient Instrumentation (CPI) than with conventional instrumentation. Each case will be recorded by video camera, in order to time the length of surgery and each surgical step. The number of surgical trays required for each case will be recorded. As an additional endpoint, the investigators will measure limb and component alignment on x-rays to determine if these two methods achieve equivalent alignment results. The thickness of bone cuts will be compared to the surgical plan and to each other. The primary hypothesis is that the use of customized patient instrumentation will reduce the operative time required for total knee arthroplasty.

Key facts

Study ID

NCT01124305

Run by

Anderson Orthopaedic Research Institute

People needed

70

Starts

2010-05-01

Expected to finish

2012-11-01

Last updated by the study team

2013-12-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient requires unilateral primary total knee arthroplasty

You may not qualify if…

• Body mass index greater than 41
• Previous ipsilateral hip or ankle replacement
• Knee flexion contracture greater than 20 degrees

Where it is running

• Anderson Orthopaedic Research Institute — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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