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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Device: internal fixation implantation of dynamic hip screw; Device: internal fixation implantation of cannulated compression screw

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic hip screw (DHS)	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.
Active Comparator: Cannulated compression screw (CCS)	Device: internal fixation implantation of cannulated compression screw; Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Femoral neck fracture; Internal fixation of fracture; Dynamic hip screw; Cannulated compression screw
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: PekingUTH ZF DHS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes