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

Not Applicable

Completed

• Conditions: Femoral Neck Fractures
• Interventions: Device: internal fixation implantation of cannulated compression screw; Device: internal fixation implantation of dynamic hip screw

• Registration Number: NCT04959370
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2016-06
• Study Completion: 2018-09
• Status Verified: 2021-07
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• fresh femoral neck fracture
• can walk before fracture
• less than 65 years old

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannulated compression screw (CCS)	internal fixation implantation of cannulated compression screw	-
Dynamic hip screw (DHS)	internal fixation implantation of dynamic hip screw	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Harris hip score	from operation to 1-year follow-up after the surgery	the score value is from 0 to 100, and a higher score means a better outcome
operation time	intraoperation	from the incision to internal fixation implanted
The times of intraoperative fluoroscopy	intraoperation	average 25 milliseconds per X-ray shot, record the number of X-ray shot
Garden index	from operation to 1-year follow-up after the surgery	The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.
Number of Participants with Postoperative adverse events	from operation to 1-year follow-up after the surgery	including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
A 12-Item Short-Form Health Survey (SF-12)	from operation to 1-year follow-up after the surgery	the score value is from 0 to 100, and a higher score means a better outcome
Number of Participants with Bone nonunion	from operation to 1-year follow-up after the surgery	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China