Femoral Neck FracturesNCT05577780
Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
An observational study of Femoral Neck Fractures, run by Mongi Slim Hospital.
Trial summary
The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- internal fixation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2015to 10 Jan 2023
- 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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Femoral neck fracture between 45 and 64 years
Who may be able to join
- Femoral neck fracture between 45 and 64 years
Who cannot join
None listed.
About this study
The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject.
The aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options
Read the detailed description
Our study was retrospective descriptive including patients aged between 45 and 64 years operated between January 2015 and December 2022 for femoral neck fracture. The patients will be divided into two groups: The internal fixation group and the arthroplasty group . Epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.
- Conditions
- Femoral Neck Fractures
- Being tested
- internal fixation
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal fixationProcedure or surgery
Also called arthroplasty
Patients with femoral neck fractures are treated with pinning or hip arthroplasty, depending on the age of the patient and the presence and degree of displacement
| Study group | Role | What they receive |
|---|---|---|
| internal fixation | Not described Receives: Procedure: internal fixation | |
| arthroplasty | Not described Receives: Procedure: internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parker Mobility Score
The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility
Measured: Baseline, Month 3
The Parker Mobility Score
The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility
Measured: Baseline, Month 6
GARDEN classification
Garden described particular femoral neck and acetabular trabeculae patterns which can assist in recognizing differences within this classification system
Garden stage I: undisplaced incomplete, including valgus impacted fractures medial group of femoral neck trabeculae may demonstrate a greenstick fracture Garden stage II: undisplaced complete no disturbance of the medial trabeculae Garden stage III: complete fracture, incompletely displaced femoral head tilts into a varus position causing its medial trabeculae to be out of line with the pelvic trabeculae Garden stage IV: complete fracture, completely displaced femoral head aligned normally in the acetabulum and its medial trabeculae are in line with the pelvic trabeculae In general, stage I and II are stable fractures and can be treated with internal fixation (head-preservation) and stage III and IV are unstable fractures and hence treated with arthroplasty (either hemi- or total arthroplasty)
Measured: Baseline
Postel Merle d'Aubigné score(PMA)
the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.
Measured: Baseline, Month 3
Postel Merle d'Aubigné score(PMA)
the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start10 Jan 2015
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed hedi ezzine, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577780
- Sponsor's protocol ID
- mongislim1
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Neck Fracture Between 45 and 64 Years : Internal Fixation Versus Arthroplasty
- ClinicalTrials.gov ID
- NCT05577780
- Acronym / sponsor ID
- mongislim1
- Conditions
- Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 13 Oct 2022 (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.
The therapeutic choice for femoral neck fracture is conventionally made between conservative treatment and total hip arthroplasty. This choice for patients aged between 45 and 64 years old remains a controversial subject.
The aim of our work was to describe the current situation in the management of femoral neck fractures in these patients and to evaluate the results of the two options
Detailed description
Our study was retrospective descriptive including patients aged between 45 and 64 years operated between January 2015 and December 2022 for femoral neck fracture. The patients will be divided into two groups: The internal fixation group and the arthroplasty group . Epidemiological, clinical and radiological data as well as therapeutic results and postoperative complications will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internal fixation | – | Procedure: internal fixation |
| arthroplasty | – | Procedure: internal fixation |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Femoral neck fracture between 45 and 64 years
Key inclusion criteria (1 listed)
- Femoral neck fracture between 45 and 64 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| internal fixationAlso: arthroplastyPatients with femoral neck fractures are treated with pinning or hip arthroplasty, depending on the age of the patient and the presence and degree of displacement | Procedure or surgery | arthroplasty, internal fixation |
Primary outcome
The Parker Mobility Score
Time frame: Baseline, Month 3
The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility
The Parker Mobility Score
Time frame: Baseline, Month 6
The Parker Mobility Score answers three questions, each valued 0-3 points. Based on the sum of the mobility assessment in three different situations (able to get about the house, able to get out of the house and able to go shopping), the total score ranges from 0-9. For each of the three situations the mobility has to be scored on: no difficulty (3 points), with an aid (2 points), with help from another person (1 point) or not at all (0 points). The highest overall score of 9 indicates the best possible mobility
GARDEN classification
Time frame: Baseline
Garden described particular femoral neck and acetabular trabeculae patterns which can assist in recognizing differences within this classification system Garden stage I: undisplaced incomplete, including valgus impacted fractures medial group of femoral neck trabeculae may demonstrate a greenstick fracture Garden stage II: undisplaced complete no disturbance of the medial trabeculae Garden stage III: complete fracture, incompletely displaced femoral head tilts into a varus position causing its medial trabeculae to be out of line with the pelvic trabeculae Garden stage IV: complete fracture, completely displaced femoral head aligned normally in the acetabulum and its medial trabeculae are in line with the pelvic trabeculae In general, stage I and II are stable fractures and can be treated with internal fixation (head-preservation) and stage III and IV are unstable fractures and hence treated with arthroplasty (either hemi- or total arthroplasty)
Postel Merle d'Aubigné score(PMA)
Time frame: Baseline, Month 3
the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.
Postel Merle d'Aubigné score(PMA)
Time frame: Baseline, Month 6
the rating of Postel Merle D'Aubigné studies the pain, mobility and the walk and gives them a value from 0 to 6, allowing a global assessment of hip's function with a total of 18 marks for a normal hip. The PMA score is excellent if the score is 18, very good if the score is 17, good if the score is between 15 and 16, average if the score is between 13 and 14, poor if the score is between 9 and 12 and bad if the score is less than 9.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures, run by Mongi Slim Hospital.
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 0 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The Parker Mobility Score (time frame: Baseline, Month 3). The study lists 5 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 13 Oct 2022.