Cut-out of the Cervical Screw on Pertrochanteric Fractures

NCT04175548 | Completed

• 1 other identifier: CHUB-Lahsika
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pertrochanteric Fracture

Outcome Measures

Primary Outcomes (9)

• Ender Classification

  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

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

  5 minutes

• Type of osteosynthesis

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

  5 minutes

• Correct positioning of the screw

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

  5 minutes

• Delay between fracture and screw cut-off

  Delay between fracture and screw cut-off

  up to 18 months

• Tip Apex Distance (TAD)

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

  5 minutes

• Parker ratio

  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

  Age of the patient

  5 minutes

• Sex

  Sex of the patient

  5 minutes

Study Arms (1)

surgery for a pertrochanteric fracture

Patients having had surgery for a pertrochanteric fracture at the CHU Brugmann Hospital between January 2013 and May 2019.

Other: Data extraction from medical files

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

surgery for a pertrochanteric fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tamas Illes: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Officials

• Mohammed Lahsika, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Orthopedic Surgery Department

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: August 13, 2019
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)