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| Name | Class |
|---|---|
| Qianfoshan Hospital | OTHER |
| Chifeng Municipal Hospital | OTHER |
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This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical robotic system. The patients in the control group do not use the surgical robotic system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robotic | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "VTS" surgical robotic system | Device | The"VTS" surgical robotic system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track and locate the surgical instruments during the operation. With the help of the robotic arm, the surgeon can make the operation procedure more accurate and safer. |
| Measure | Description | Time Frame |
|---|---|---|
| Acetabular location accuracy | Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area | Within 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Time from skin incision to wound closure | Immediately after surgery |
| the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC is a self administered questionnaire to assess joint function and quality of life for patients with osteoarthritis; it consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). The higher the total score, the worse the patient's pain, stiffness, and functional limitations. The WOMAC is validated for various languages, including Chinese |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100181 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39420701 | Derived | Geng X, Dong Z, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Precise Acetabular Prosthesis Positioning Using a Novel Robot-Assisted Total Hip Arthroplasty System: A Multicenter, Randomized Controlled Trial. Orthop Surg. 2025 Jan;17(1):141-150. doi: 10.1111/os.14277. Epub 2024 Oct 17. |
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|
| 6 months after surgery |
| Harris Hip Score (HHS) | a rating scale with a maximum of 100 points, including the domains of pain, function, deformity, and motion | 6 months after surgery |
| 36-Item Short Form Survey (SF-36) | The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. | 6 months after surgery |
| dislocation rate of hip joint | the proportion of participants encountered with dislocation of hip joint after THA | 6 months after surgery |
| adverse events or complications | the rate of adverse events or complications in all the participants | 6 months after surgery |