Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture

Study Overview
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Brief Summary
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For fresh femoral neck fracture internal fixation, both DHS and CCS can make strong fixation of hip and have good recovery. There is no statistical difference in complications after surgery between the two procedures. Patients with DHS internal fixation have earlier postoperative weight bearing, which is conducive to functional exercise of the injured limb. DHS internal fixation system is recommended for patients with unstable fractures and severe osteoporosis.

Detailed Description
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Objective: To compare the clinical effect of dynamic hip screw (DHS) and cannulated compression screw (CCS) in the treatment of fresh femoral neck fracture. Methods: A retrospective study was conducted to analyze the data of 91 patients with fresh femoral neck fracture treated with DHS or CCS in our hospital from January 2012 to June 2016.The cases were divided into two groups according to internal fixation: 44 cases in the DHS group and 47 cases in the CCS group. By comparing operative time, intraoperative bleeding, postoperative load, Harris scoring and the complications such as postoperative necrosis of femoral head and shortening of femoral neck appearance, we evaluated the clinical curative effect of two kinds of fixation.

Official Title
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Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Device: internal fixation implantation of dynamic hip screw
* Device: internal fixation implantation of cannulated compression screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fresh femoral neck fracture can walk before fracture less than 65 years old Exclusion Criteria: Patients combined with other bone fractures. Pathological fracture (e.g., primary or metastatic tumor) Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome. Multiple systemic injuries judged by researchers not suitable for enrollment. Revision surgeries (for example, due to malunion, nonunion or infection) Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc Patients known to be allergic to implant components Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months) Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic hip screw (DHS)<br> | Device: internal fixation implantation of dynamic hip screw<br>* Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.<br>|
| Active Comparator: Cannulated compression screw (CCS)<br> | Device: internal fixation implantation of cannulated compression screw<br>* Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal fixation failure rate | defined as the total incidence of internal plant cut-out and fracture. | from operation to 1-year follow-up after the surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 1-year follow-up after the surgery | 
| Harris hip score | the score value is from 0 to 100, and a higher score means a better outcome | from operation to 1-year follow-up after the surgery | 
| operation time | from the incision to internal fixation implanted | intraoperation | 
| The times of intraoperative fluoroscopy | average 25 milliseconds per X-ray shot, record the number of X-ray shot | intraoperation | 
| 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 1-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 1-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 1-year follow-up after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoral neck fracture, Internal fixation of fracture, Dynamic hip screw, Cannulated compression screw