Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of Knee
• Intervention / Treatment: Device: Medacta GMK Sphere

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine Department of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Manual (tibia) and manual (femur); Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component	Device: Medacta GMK Sphere
Other: 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	Device: Medacta GMK Sphere
Other: Custom (tibia) and custom (femur); Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component	Device: Medacta GMK Sphere
Other: 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	Device: Medacta GMK Sphere

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Hip-Knee-Angle (HKA)	Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation	Pre-operative, 6 wks. post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tibial Varus Deformity	Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint	Pre-operative, 6 wks. post-op
Femoral Valgus Deformity	Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint	Pre-operative, 6 wks. post-op
Tibial Posterior Slope (Mean Deviation)	Deviation from pre-operative planning template & 6 wk. post-operative longstanding EOS radiograph	Pre-Operative - 6 wk. Post-Operative

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 8, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: STU00200223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes