At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation
In Brief
A Phase 4 clinical trial evaluating Customized Patient Instrumentation and Traditional Instrumentation for Knee Arthritis. Completed, enrolled 70 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.