Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation

NCT ID: NCT02579174

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-11-30

Brief Summary

1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)

2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.

3. To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT

Detailed Description

Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.

Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.

The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual (tibia) and manual (femur)

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component

Group Type: OTHER

Medacta GMK Sphere

Intervention Type: DEVICE

Manual (tibia) and custom (femur)

Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component

Group Type: OTHER

Medacta GMK Sphere

Intervention Type: DEVICE

Custom (tibia) and custom (femur)

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component

Group Type: OTHER

Medacta GMK Sphere

Intervention Type: DEVICE

Custom (tibia) and manual (femur)

Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component

Group Type: OTHER

Medacta GMK Sphere

Intervention Type: DEVICE

Interventions

Medacta GMK Sphere

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Radiographically confirmed diagnosis of osteoarthritis (OA)
• Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
• Age greater than 18 years
• Desire to proceed with elective TKR
• Completion of informed consent and signature of written consent form

Exclusion Criteria

• Ligamentous instability that may necessitate a constrained TKR implant
• Retained hardware in the distal femur or proximal tibia of the operative extremity
• Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David W. Manning

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00200223

Identifier Type: -

Identifier Source: org_study_id