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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04175548
Other study ID # CHUB-Lahsika
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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