3D Printing Guides in Total Knee Arthroplasty
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Device: 3D-Printed Patient-Specific Intramedullary Guide
- Registration Number
- NCT04206202
- Lead Sponsor
- Southwest Hospital, China
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PSI group 3D-Printed Patient-Specific Intramedullary Guide 3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Southwest Hospital
🇨🇳Chongqing, China