NCT04959370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

4.4 years

First QC Date

July 2, 2021

Last Update Submit

July 12, 2021

Conditions

Femoral Neck Fractures

Keywords

Femoral neck fractureInternal fixation of fractureDynamic hip screwCannulated compression screw

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of Participants with Bone nonunion

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

  • Harris hip score

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

  • operation time

    intraoperation

  • The times of intraoperative fluoroscopy

    intraoperation

  • Number of Participants with Postoperative adverse events

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

  • +2 more secondary outcomes

Study Arms (2)

Dynamic hip screw (DHS)

EXPERIMENTAL
Device: internal fixation implantation of dynamic hip screw

Cannulated compression screw (CCS)

ACTIVE COMPARATOR
Device: internal fixation implantation of cannulated compression screw

Interventions

internal fixation implantation of dynamic hip screwDEVICE

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

Dynamic hip screw (DHS)
internal fixation implantation of cannulated compression screwDEVICE

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

Cannulated compression screw (CCS)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

January 1, 2012

Primary Completion

June 1, 2016

Study Completion

September 1, 2018

Last Updated

July 13, 2021

Record last verified: 2021-07

Locations

CN(1)