Cut-out of the Cervical Screw on Pertrochanteric Fractures

Pertrochanteric Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04175548
• Other study ID #: CHUB-Lahsika
• Status: Completed
• Start date: August 13, 2019
• Est. completion date: November 23, 2020

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pertrochanteric Fracture

Intervention

Other:
• Data extraction from medical files
Data extraction from medical files

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Tamas Illes

Country where clinical trial is conducted

Belgium, 

Outcome

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