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The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three cannulated compression screws by navigation system | Experimental |
| |
| Traditional three cannulated compression screws | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Three cannulated compression screws by navigation system | Procedure | Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system |
| Measure | Description | Time Frame |
|---|---|---|
| Perspective frequency | Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Neck shaft angle | 1 year | |
| Guide needle implantation effect | For the group treated with three hollow compression screws, the effect of the implantation of guide pins is categorized into three parallel pins, two parallel pins, and mutually non-parallel pins, with measurements taken during the surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zhang | Contact | +8612409252 | bszw@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42335459 | Derived | Li M, Tong D, Cheng M, Li J, Ji F, Zhang W. Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 23;15:e88180. doi: 10.2196/88180. |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| Traditional three cannulated compression screws | Procedure | Patients with femoral neck fractures treated with traditional three cannulated compression screws |
|
| 1 day |
| Fluoroscopy times of needle implantation | 1 day |
| Operation time | 1 day |
| Operative blood loss | 1 day |
| Fracture union | Postoperative follow-up observation is conducted for all patients, with anteroposterior and lateral hip X-rays taken at the 1st, 3rd, 6th, and 12th postoperative months. X ray and CT scans are reviewed at the 1st and 3rd postoperative months to observe the stability of the implanted internal fixation, the disappearance of the fracture line, and whether there is displacement of the fracture ends. | 1 year |
| Zarit Burden Interview score | The Zarit Burden Interview (ZBI) is a commonly used assessment tool designed to quantify the psychological and emotional burden experienced by caregivers who provide care for individuals with cognitive or functional impairments. Developed by Zarit and colleagues, the scale consists of 22 items that cover various aspects of caregiver burden, such as time pressure, emotional strain, and social isolation. The scoring ranges from 0 to 88, with higher scores indicating a greater level of caregiving burden. This tool aids healthcare professionals in identifying the psychological stress faced by caregivers and provides appropriate support and interventions to improve their mental health and quality of life. | 1 year |
| Harris score | The Harris Score (Harris Hip Score, HHS) is a widely used scale for evaluating hip joint function and patient quality of life, often applied to assess the outcomes of hip replacement surgery or other treatments for hip joint diseases. It covers four main aspects: pain level, functional activity, joint range of motion, and hip joint deformity. The total score ranges from 0 to 100, with 100 being the best possible condition, indicating complete normalcy of hip joint function. | 1 year |
| SF-36 score | The SF-36 (Short Form 36 Health Survey) is a widely used generic health status assessment tool developed by the Medical Outcomes Study (MOS) Group. The scale is designed to comprehensively evaluate health-related quality of life, encompassing eight dimensions: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, bodily pain, mental health, vitality, and general health perceptions. Each dimension consists of several items, and scores are derived by summing the scores of these items, typically converted to a 0 to 100 percent scale, with 100 representing the best possible health state. These eight dimension scores can be combined to form two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). | 1 year |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |