Clinical trial NCT04959370: Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture
Official title: Comparison of Clinical Efficacy Between Dynamic Dip Screw and Cannulated Compression Screw for Fresh Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Femoral neck fracture
Internal fixation of fracture
Dynamic hip screw
Cannulated compression screw
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Internal fixation failure rate
timeFrame: from operation to 1-year follow-up after the surgery
Secondary outcomes:
measure: Number of Participants with Bone nonunion
timeFrame: from operation to 1-year follow-up after the surgery
measure: Harris hip score
timeFrame: from operation to 1-year follow-up after the surgery
measure: operation time
timeFrame: intraoperation
measure: The times of intraoperative fluoroscopy
timeFrame: intraoperation
measure: Number of Participants with Postoperative adverse events
timeFrame: from operation to 1-year follow-up after the surgery
measure: Garden index
timeFrame: from operation to 1-year follow-up after the surgery
measure: A 12-Item Short-Form Health Survey (SF-12)
timeFrame: from operation to 1-year follow-up after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: