Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/23/2019 |
| Start Date: | January 2015 |
| End Date: | May 31, 2019 |
| Contact: | Surabhi Bhatt, BS |
| Email: | surabhi-bhatt@northwestern.edu |
| Phone: | 312-472-6024 |
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
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
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.
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.
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
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