3D Printing Guides in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of 3D Printing Patient-specific Instrumentation in Total Knee Arthroplasty

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Device: 3D-Printed Patient-Specific Intramedullary Guide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSI group<br>3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group. | Device: 3D-Printed Patient-Specific Intramedullary Guide<br>* The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the radiological outcomes | 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. | Postoperative 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital for Special Surgery knee score (HSS) | 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. | Postoperative 1,6,12 months | 
| American Knee Society knee score (AKS) | 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. | Postoperative 1,6,12 months |