Knee Arthroplasty Performed With Conventional and Customized Instrumentation (CPI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124305
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : January 21, 2013
Last Update Posted : December 18, 2013
Information provided by (Responsible Party):
Nancy Parks, Anderson Orthopaedic Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Arthritis Device: Customized Patient Instrumentation Device: Traditional Instrumentation Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Evaluation of Total Knee Arthroplasty Performed With Conventional and Customized Patient Instrumentation
Study Start Date : May 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Traditional Instrumentation
Control group: Cases performed with traditional surgical instruments
Device: Traditional Instrumentation
Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
Experimental: Customized Patient Instrumentation
Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
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.

Primary Outcome Measures :
  1. Length of Surgery [ Time Frame: 1 day ]
    Time elapsed from skin incision to wound closure (in seconds)

Secondary Outcome Measures :
  1. Length of Each Surgical Step (in Seconds) [ Time Frame: 1 day ]
    surgical exposure, tibial alignment and resection, femoral distal cut, extension gap balancing, sizing the femur, 4 finishing femoral cuts, posterior releases, patellar resection, trial components, tibial tray preparation, cleanup/ prep for cement, cementing femur, cementing tibia, cementing patella, and closure

  2. Number of Instrument Trays Required [ Time Frame: 1 day ]
  3. Limb Alignment (Mechanical Axis) [ Time Frame: 4 months ]
    Alignment is measured on 4 month postoperative radiograph in degrees. The goal is a mechanical axis between and femur and tibia of 0 degrees. Varus alignment ("bow-legged") is shown as a negative number in degrees away from 0. Valgus alignment ("Knock-kneed") is expressed as a positive number in degrees away from 0.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient requires unilateral primary total knee arthroplasty

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01124305

United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22306
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
Principal Investigator: William G Hamilton, MD Anderson Orthopaedic Research Institute