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| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| Beijing Jishuitan Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
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This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up. The patients are divided into the FNS group and the MCS group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of FNS in the Chinese population, and verify the safety and efficacy of FNS for patients with femoral neck fracture.
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use FNS for internal fixation in Group 1 and MCS in Group 2. Since FNS is clinically comparable to the Dynamic Hip Screw (DHS) system, investigators used DHS clinical data as a statistical reference. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 290. The FNS group and the MCS group each included 145 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. For the MCS group, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the two-year follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per X-ray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synthes Femoral Neck System (FNS) | Experimental | Synthes Femoral Neck System (FNS) was developed with the intention to combine advantages of DHS (dynamic hip screw) and MCS (multiple cancellous screw). The FNS implants consist of plates, bolts, locking screws and antirotating-screws. The plate consists of a small base plate with one or two locking holes and a barrel portion. The barrel allows for gliding of the head elements while restricting rotation around the head-neck axis, so FNS is a fixed-angle gliding fixation device that allows for controlled collapse of the femoral neck, like DHS. The FNS was also designed to minimize implant footprint on the bone with its compact design, like MCS. Furthermore, the FNS was designed to reduce the length of incision necessary for implant insertion when compared to DHS. This new concept of femoral neck fracture fixation still emphasizes the biology of fracture healing by initial fracture compression. |
|
| Multiple cancellous screws (MCS) | Active Comparator | Multiple cancellous screws (MCS) fixation is the most common and classic method to deal with femoral neck fractures which is less invasive and retains more viable bone, compared with dynamic hip screw (DHS) fixation that appears biomechanically more stable. In this study, three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FNS | Device | perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Internal fixation failure rate | defined as the total incidence of internal plant cut-out and fracture. | from operation to 2-year follow-up after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Bone nonunion | evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion. | from operation to 2-year follow-up after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangyu Xu, MD | Contact | +86-15210849431 | 307542744@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Zhou, MD | Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 6, 2026 | Jun 1, 2026 | 5 | ||
| Jun 22, 2026 |
| 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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| Tianjin Hospital |
| OTHER |
| The Fuzhou No 2 Hospital | OTHER |
| Xi'an Honghui Hospital | OTHER |
| West China Hospital | OTHER |
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral neck fracture (AO classification 31-B) using Femoral Neck System (FNS) versus Multiple Cancellous Screws (MCS) at 2-year follow up.The patients are divided into the FNS group and the MCS group according to the internal fixation they choose.
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| MCS | Device | three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck. |
|
| Harris hip score | the score value is from 0 to 100, and a higher score means a better outcome | from operation to 2-year follow-up after the surgery |
| operation time | from the incision to internal fixation implanted. | intraoperative |
| The times of intraoperative fluoroscopy | average 25 milliseconds per X-ray shot, record the number of X-ray shot | intraoperative |
| Number of Participants with Postoperative adverse events | including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening | from operation to 2-year follow-up after the surgery |
| Garden index | The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees. | from operation to 2-year follow-up after the surgery |
| A 12-Item Short-Form Health Survey (SF-12) | the score value is from 0 to 100, and a higher score means a better outcome | from operation to 2-year follow-up after the surgery |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |