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NCT Number: NCT04175548

Cut-out of the Cervical Screw on Pertrochanteric Fractures

Pertrochanteric fractures are a highly relevant topic not only because of the high frequency or age of the population concerned, but also because of comorbidity (osteoporosis, malnutrition, decreased physical activity, decreased visual acuity, neurological deficits, asthenia, disorders of the equilibrium and impaired reflexes) and the mortality associated with this type of fractures.

The cut-out of the cervical screw is a mechanical complication common to different means of osteosynthesis of pertrochanteric fractures, this complication significantly increases the morbidity.

From January 2013 to May 2019, out of a total of 340 patients having had surgery for pertrochanteric fracture, 12 cases of cervical screw cut-out were recorded within the Brugmann University Hospital. The average follow-up after surgery was 18 months.

This study analyses different parameters and their link with cervical screw cut-outs, and compares the results with the ones published in the scientific literature.

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Key information

Conditions

Pertrochanteric Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients admitted for a pertrochanteric and subtrochanteric fracture of the femur treated by cerebrospinal nailing with all the methods of fixation of the head (blade or screw) and who evolved to a cut-out of the cervical screw.

Exclusion criteria

  • Fractures treated by open osteosynthesis
  • Fractures operated with good radiological outcome
  • Incomplete or non useable medical files

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Ender Classification

    Time frame: 5 minutes

    Ender classification of the fracture. I: stable basal-cervical fracture. II: stable pertrochanteric fracture. III: unstable intertrochanteric fracture. IV: unstable subtrochanteric fracture. V: unstable trochantero-diaphyseal fracture

  2. Bone quality

    Time frame: 5 minutes

    Presence of osteoporosis or pathologies inside the bone (yes/no)

  3. Type of osteosynthesis

    Time frame: 5 minutes

    Material used. Choice between: short/long gamma nail, long/short PFNA nail, long/short Affixus nail

  4. Correct positioning of the screw

    Time frame: 5 minutes

    Correct positioning of the screw on radiological images (yes/no)

  5. Delay between fracture and screw cut-off

    Time frame: up to 18 months

    Delay between fracture and screw cut-off

  6. Tip Apex Distance (TAD)

    Time frame: 5 minutes

    TAD is a measure of how close the tip of the lag screw lies to the femoral apex.

  7. Parker ratio

    Time frame: 5 minutes

    This method involves recording the superior, inferior, anterior and posterior borders of the femoral head. The ratio is calculated in both the AP and lateral views to give a value within a range of 0 to 100 for each view. In the AP view, 0 is considered to be the most inferior screw placement and 100 is considered to be the most superior pin placement. In the lateral view, 0 is considered to be the most posterior screw placement and 100 is considered to be the most anterior pin placement.

  8. Age

    Time frame: 5 minutes

    Age of the patient

  9. Sex

    Time frame: 5 minutes

    Sex of the patient

Sponsors and collaborators

Lead sponsor

Tamas Illes

Other

Registry information

Official study title

Cut-out of the Cervical Screw on Pertrochanteric Fractures: Retrospective Analysis of 12 Cases

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 25, 2019
Registry last updated
Jul 20, 2022

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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