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Knee Arthroplasty Performed With Conventional and Customized Instrumentation

NCT01124305 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-12-18

Study results available
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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.

Conditions

  • Knee Arthritis

Interventions

DEVICE

Customized Patient Instrumentation

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.

DEVICE

Traditional Instrumentation

Traditional surgical instruments will be used to make bone cuts and size the components in this control group.

Sponsors & Collaborators

  • Anderson Orthopaedic Research Institute

    lead OTHER

Principal Investigators

  • William G Hamilton, MD · Anderson Orthopaedic Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124305 on ClinicalTrials.gov