3D Printing Guides in Total Knee Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PSI group 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
The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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Weight-bearing radiograph of the X-ray image showed the OA Kellgren-Lawrence classification grade Ⅳ;
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The treatment for the patient was TKA, whether or not to use PSI depends on the actual grouping.
Exclusion Criteria:
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Patients with varus deformity of more than 15 degrees, flexion-contracture deformity of more than 10 degrees of the knee;
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Patients with traumatic arthritis and inflammatory arthritis;
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Patients with huge bone defects around the knee
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Patients who had active infection around the knee;
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Patients with knee valgus deformity;
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Patients with severe extra-articular deformity;
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Patients who had previous knee surgery;
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Patients who had periarticular soft tissue dysfunction and neuropathy;
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Patients who had poor physical condition and could not withstand the operation;
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Patients who refused to be followed.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southwest Hospital | Chongqing | China |
Sponsors and Collaborators
- Southwest Hospital, China
Investigators
- Principal Investigator: Rui He, M.D., Southwest Hospital, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3DKneeGuide