Cut-out of the Cervical Screw on Pertrochanteric Fractures

July 19, 2022 updated by: Tamas Illes

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgery for a pertrochanteric fracture
Patients having had surgery for a pertrochanteric fracture at the CHU Brugmann Hospital between January 2013 and May 2019.
Data extraction from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex
Time Frame: 5 minutes
Sex of the patient
5 minutes
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
5 minutes
Bone quality
Time Frame: 5 minutes
Presence of osteoporosis or pathologies inside the bone (yes/no)
5 minutes
Type of osteosynthesis
Time Frame: 5 minutes
Material used. Choice between: short/long gamma nail, long/short PFNA nail, long/short Affixus nail
5 minutes
Correct positioning of the screw
Time Frame: 5 minutes
Correct positioning of the screw on radiological images (yes/no)
5 minutes
Delay between fracture and screw cut-off
Time Frame: up to 18 months
Delay between fracture and screw cut-off
up to 18 months
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.
5 minutes
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.
5 minutes
Age
Time Frame: 5 minutes
Age of the patient
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Mohammed Lahsika, MD, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2019

Primary Completion (Actual)

November 23, 2020

Study Completion (Actual)

November 23, 2020

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-Lahsika

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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