Cut-out of the Cervical Screw on Pertrochanteric Fractures

Completed

• Conditions: Pertrochanteric Fracture

• Registration Number: NCT04175548
• Lead Sponsor: Tamas Illes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-13
• Study First Submitted: 2019-11-21
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-25
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ender Classification	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
Bone quality	5 minutes	Presence of osteoporosis or pathologies inside the bone (yes/no)
Type of osteosynthesis	5 minutes	Material used. Choice between: short/long gamma nail, long/short PFNA nail, long/short Affixus nail
Correct positioning of the screw	5 minutes	Correct positioning of the screw on radiological images (yes/no)
Delay between fracture and screw cut-off	up to 18 months	Delay between fracture and screw cut-off
Tip Apex Distance (TAD)	5 minutes	TAD is a measure of how close the tip of the lag screw lies to the femoral apex.
Parker ratio	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.
Age	5 minutes	Age of the patient
Sex	5 minutes	Sex of the patient

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium