- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175548
Cut-out of the Cervical Screw on Pertrochanteric Fractures
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1020
- CHU Brugmann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Mohammed Lahsika, MD, CHU Brugmann
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Pertrochanteric Fracture
-
Ilocos Training and Regional Medical CenterUnknownIntertrochanteric Fractures | Pertrochanteric Fracture | Pertrochanteric Fracture of Femur, Closed | Pertrochanteric Fracture of Femur, Open
-
Aarhus University HospitalCompletedPertrochanteric FractureDenmark
-
Aga Khan University Hospital, PakistanAO Trauma Middle East and North AfricaRecruitingClinical Trial | Fragility Fracture | Femur; Fracture, PertrochantericPakistan
-
Meir Medical CenterUnknownPertrochanteric FractureIsrael
-
NYU Langone HealthCompletedPertrochanteric FractureUnited States
-
Fraser Orthopaedic Research SocietyDePuy SynthesRecruitingPertrochanteric FractureCanada
-
Milton S. Hershey Medical CenterWithdrawnPertrochanteric Fracture of Femur, Closed
-
University General Hospital of PatrasRecruitingPertrochanteric Fracture of Femur, ClosedGreece
-
Mayo ClinicCompletedPertrochanteric Hip FractureUnited States
-
Orthofix s.r.l.Active, not recruitingHip Fractures | Intertrochanteric Fractures | Pertrochanteric Fracture | Subtrochanteric FracturesItaly
Clinical Trials on Data extraction from medical files
-
Brugmann University HospitalCompleted
-
Brugmann University HospitalCompletedCovid19Belgium, Italy, France
-
Agnieszka PozdzikCompletedHypercalciuria; IdiopathicBelgium
-
Brugmann University HospitalCompleted
-
Dr Philippe CLEVENBERGHCompleted
-
Agnieszka PozdzikCompleted
-
Pierre WauthyCompleted
-
BADOT, ValerieUnknownRheumatoid PolyarthritisBelgium