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Completed

NCT Number: NCT04959370

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.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

internal fixation implantation of dynamic hip screw

Device

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

internal fixation implantation of cannulated compression screw

Device

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

Primary outcomes

  1. Internal fixation failure rate

    Time frame: from operation to 1-year follow-up after the surgery

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

Secondary outcomes

  1. Number of Participants with Bone nonunion

    Time frame: 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.

  2. Harris hip score

    Time frame: 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

  3. operation time

    Time frame: intraoperation

    from the incision to internal fixation implanted

  4. The times of intraoperative fluoroscopy

    Time frame: intraoperation

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

  5. Number of Participants with Postoperative adverse events

    Time frame: 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

  6. Garden index

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Jul 13, 2021
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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