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

Femoral Neck Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04959370
• Other study ID #: PekingUTH ZF DHS
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: September 2018

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Device:
• internal fixation implantation of dynamic hip screw
Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.
• internal fixation implantation of cannulated compression screw
Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	operation time	from the incision to internal fixation implanted	intraoperation
Secondary	The times of intraoperative fluoroscopy	average 25 milliseconds per X-ray shot, record the number of X-ray shot	intraoperation
Secondary	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
Secondary	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
Secondary	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