Osteoarthritis of the Knee
Conditions
Brief summary
This study aims to design a patient-specific instrumentation to be used in total knee arthroplasty and evaluate its accuracy of femoral component rotation and intramedullary guide so as to explore its clinical effects.
Detailed description
Total knee arthroplasty (TKA) is the most universal and effective means for treating terminal stage osteoarthritis (OA) of knee. With the development of three-dimensional printing (3DP) technology in the medical domain, the application of patient-specific instrumentation (PSI) in arthroplasty has become more common. The aim of this study was to design a PSI to achieve appropriate femoral resection and accurate component rotation for a successful TKA, and to explore its clinical effects.
Interventions
DEVICE3D-Printed Patient-Specific Intramedullary Guide
The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.
Sponsors
Southwest Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced OA of the knee, varus deformity of no more than 15 degrees, flexion-contracture deformity of no more than 10 degrees, without extra-articular deformity of the knee; * Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ; * The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.
Exclusion criteria
* Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee; * Patients with traumatic arthritis and inflammatory arthritis; * Patients with huge bone defects around the knee * Patients who had active infection around the knee; * Patients with knee valgus deformity; * Patients with severe extra-articular deformity; * Patients who had previous knee surgery; * Patients who had periarticular soft tissue dysfunction and neuropathy; * Patients who had poor physical condition and could not withstand the operation; * Patients who refused to be followed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the radiological outcomes | Postoperative 12 months | The radiological outcomes include the hip-knee-ankle angle (HKA), posterior condylar angle (PCA), patella transverse axis-femoral transepicondylar axis angle (PFA) of the patients. The data were collected to evaluate the accuracy of the 3DP-designed PSI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital for Special Surgery knee score (HSS) | Postoperative 1,6,12 months | Hospital for Special Surgery knee score (HSS) was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 6 aspects as pain, function, muscle force, deformity, stability, and the range of motion. The score standard had a maximum of 100 points (best possible outcome). A total score \<60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent. |
| American Knee Society knee score (AKS) | Postoperative 1,6,12 months | The AKS was used to evaluate postoperative recovery of knee function in an adult population. The HSS score system mainly includes 4 aspects as pain, stability, range of motion and the function. The score standard had a maximum of 100 points (best possible outcome). A total score \<60 is considered a poor score, 60-69 fair,70-85 is good and 86-100 excellent. |
Countries
China
Outcome results
None listed