Pertrochanteric FractureNCT04175548
Cut-out of the Cervical Screw on Pertrochanteric Fractures
An observational study of Pertrochanteric Fracture, run by Tamas Illes at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Fracture
- What is being tested?
- Data extraction from medical files
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Aug 2019to 23 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Fractures treated by open osteosynthesis
- Fractures operated with good radiological outcome
- Incomplete or non useable medical files
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Data extraction from medical files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| surgery for a pertrochanteric fracture | Patients having had surgery for a pertrochanteric fracture at the CHU Brugmann Hospital between January 2013 and May 2019. Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Bone quality
Presence of osteoporosis or pathologies inside the bone (yes/no)
Measured: 5 minutes
Type of osteosynthesis
Material used. Choice between: short/long gamma nail, long/short PFNA nail, long/short Affixus nail
Measured: 5 minutes
Correct positioning of the screw
Correct positioning of the screw on radiological images (yes/no)
Measured: 5 minutes
Delay between fracture and screw cut-off
Delay between fracture and screw cut-off
Measured: 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.
Measured: 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.
Measured: 5 minutes
Age
Age of the patient
Measured: 5 minutes
Sex
Sex of the patient
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start13 Aug 2019
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanteric FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamas Illes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tamas Illes, Brugmann University Hospital
- Investigators
- Mohammed Lahsika, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175548
- Sponsor's protocol ID
- CHUB-Lahsika
- Status last verified
- Jul 2022
- First submitted
- 21 Nov 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cut-out of the Cervical Screw on Pertrochanteric Fractures: Retrospective Analysis of 12 Cases
- ClinicalTrials.gov ID
- NCT04175548
- Acronym / sponsor ID
- CHUB-Lahsika
- Conditions
- Pertrochanteric Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tamas IllesUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery for a pertrochanteric fracture | – | Other: Data extraction from medical filesPatients having had surgery for a pertrochanteric fracture at the CHU Brugmann Hospital between January 2013 and May 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Fractures treated by open osteosynthesis
- Fractures operated with good radiological outcome
- Incomplete or non useable medical files
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | surgery for a pertrochanteric fracture |
Primary outcome
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
Bone quality
Time frame: 5 minutes
Presence of osteoporosis or pathologies inside the bone (yes/no)
Type of osteosynthesis
Time frame: 5 minutes
Material used. Choice between: short/long gamma nail, long/short PFNA nail, long/short Affixus nail
Correct positioning of the screw
Time frame: 5 minutes
Correct positioning of the screw on radiological images (yes/no)
Delay between fracture and screw cut-off
Time frame: up to 18 months
Delay between fracture and screw cut-off
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.
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.
Age
Time frame: 5 minutes
Age of the patient
Sex
Time frame: 5 minutes
Sex of the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Lahsika, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertrochanteric Fracture, run by Tamas Illes at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ender Classification (time frame: 5 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.