Knee Arthritis Clinical Trial
Official title:
A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation
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.
Patient-specific instrumentation (PSI) has been developed for total knee arthroplasty (TKA)
with several potential advantages over traditional instrumentation (TI). Shortened surgical
time, fewer surgical instruments, and improved alignment are some of these proposed
advantages. We sought to examine these assertions.
52 patients (26 per group) were enrolled in a prospective, randomized trial comparing
CT-based PSI with TI. No difference was seen in average patient age (68 years) or BMI (31)
between groups (p=0.84 and p=0.89), although there were more males in the PSI group (14 vs
7, p=0.002). A single surgeon and consistent staff performed the surgeries with the same
knee prostheses, and all cases were videotaped to measure the length of surgery and each
individual step. Any additional bone cuts, size changes, or ligament releases made to
achieve correct alignment and balance were documented. The number of instrument trays opened
for each case was recorded. Postoperative long alignment and lateral radiographs were taken
to measure the coronal and sagittal plane component alignment and mechanical axis in each
patient.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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