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

Primary Purpose

Femoral Neck Fractures

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

internal fixation implantation of dynamic hip screw

internal fixation implantation of cannulated compression screw

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Femoral neck fracture, Internal fixation of fracture, Dynamic hip screw, Cannulated compression screw

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic hip screw (DHS)

Cannulated compression screw (CCS)

Arm Description

Outcomes

Primary Outcome Measures

Internal fixation failure rate

defined as the total incidence of internal plant cut-out and fracture.

Secondary Outcome Measures

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.

Harris hip score

the score value is from 0 to 100, and a higher score means a better outcome

operation time

from the incision to internal fixation implanted

The times of intraoperative fluoroscopy

average 25 milliseconds per X-ray shot, record the number of X-ray shot

Number of Participants with Postoperative adverse events

including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening

Garden index

The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.

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

Full Information

NCT ID

NCT04959370

First Posted

July 2, 2021

Last Updated

July 12, 2021

Sponsor

Peking University Third Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04959370

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

January 2012 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Neck Fractures

Keywords

Femoral neck fracture, Internal fixation of fracture, Dynamic hip screw, Cannulated compression screw

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dynamic hip screw (DHS)

Arm Type

Experimental

Arm Title

Cannulated compression screw (CCS)

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

internal fixation implantation of dynamic hip screw

Intervention Description

Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.

Intervention Type

Device

Intervention Name(s)

internal fixation implantation of cannulated compression screw

Intervention Description

Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.

Primary Outcome Measure Information:

Title

Internal fixation failure rate

Description

defined as the total incidence of internal plant cut-out and fracture.

Time Frame

from operation to 1-year follow-up after the surgery

Secondary Outcome Measure Information:

Title

Number of Participants with Bone nonunion

Description

Time Frame

from operation to 1-year follow-up after the surgery

Title

Harris hip score

Description

the score value is from 0 to 100, and a higher score means a better outcome

Time Frame

from operation to 1-year follow-up after the surgery

Title

operation time

Description

from the incision to internal fixation implanted

Time Frame

intraoperation

Title

The times of intraoperative fluoroscopy

Description

average 25 milliseconds per X-ray shot, record the number of X-ray shot

Time Frame

intraoperation

Title

Number of Participants with Postoperative adverse events

Description

including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening

Time Frame

from operation to 1-year follow-up after the surgery

Title

Garden index

Description

The fracture reduction will be considered unsatisfied if the index is less than 155 degrees or more than 180 degrees.

Time Frame

from operation to 1-year follow-up after the surgery

Title

A 12-Item Short-Form Health Survey (SF-12)

Description

the score value is from 0 to 100, and a higher score means a better outcome

Time Frame

from operation to 1-year follow-up after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Facility Information:

Facility Name

Peking University Third Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

12. IPD Sharing Statement

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

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