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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSI group | Experimental | 3D-printed patient-specific instrumentation (PSI) will be used in the total knee arthroplasty (TKA) of this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-Printed Patient-Specific Intramedullary Guide | Device | The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui He, M.D. | Southwest Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Chongqing | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| D012216 |
| Rheumatic Diseases |