Femoral Neck FracturesNCT04687592
Vertical Femoral Neck Fractures in Young Adult Patients
An observational study of Femoral Neck Fractures, run by Assiut University.
Trial summary
Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up? Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- reduction and fixation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Sep 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: adults patients with recent vertical femoral neck fracture
Who may be able to join
- Age of the patients from 20 to 50 years
- Pauwel type III fractures
- Recent fracture within one week
Who cannot join
- • Open fractures
- Pathological or osteoporotic fractures.
- Patient with comorbidities: D.M, renal patient, neurological deficits.
- Patient associated with femoral head fractures or head impaction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Radiological and Functional Outcomes of Internal Fixation Methods for Vertical Femoral Neck Fractures in Young Adult Patients
Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up?
Read the detailed description
- Displaced femoral neck fractures in young adults are most likely to result from high energy trauma that causes a vertically-oriented shearing injury through the femoral neck.
- The most descriptive classification used for femoral neck fractures in young patients is the Pauwels classification. As the degree of the femoral neck fracture line relative to the horizontal plane increases, the types differ (30 degrees type I, between 30 degrees and 50 degrees type II, 50 degrees type III), and the instability of the fracture.
- Greater fracture verticality contributes to greater difficulty in obtaining adequate stability to resist vertical shear forces around the hip, thereby resulting in ascending greater risk of complications such as nonunion and osteonecrosis despite a number of potential fixation strategies.
- The primary goals of surgery include preservation of the femoral head, avoidance of osteonecrosis, and achievement of a stable union.
- Fixation options include cannulated screws, sliding hip screw with or without an additional derotation screw,. among orthopedic trauma surgeons there is no consensus that a single fixation Option is superior for treating these injuries.
- Conditions
- Femoral Neck Fractures
- Being tested
- reduction and 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.
reduction and fixationProcedure or surgery
- Reduction: one trial of closed reduction under anaesthesia and image control. Open reduction will be done by anterolateral or lateral approach if closed reduction failed
- Fixation: internal fixation of the fracture by appropriate implant according to the fracture state
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological and functional evaluation of the time and rate of union according harris hip score
The domains covered in Harris hip score are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.
The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Magdi Labieb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687592
- Sponsor's protocol ID
- Femoral Neck Fractures
- Status last verified
- Dec 2020
- First submitted
- 15 Nov 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Macaulay W, Yoon RS, Parsley B, Nellans KW, Teeny SM; DFACTO Consortium. Displaced femoral neck fractures: is there a standard of care? Orthopedics. 2007 Sep;30(9):748-9. doi: 10.3928/01477447-20070901-08.
PubMed 17899921Bartonicek J. Pauwels' classification of femoral neck fractures: correct interpretation of the original. J Orthop Trauma. 2001 Jun-Jul;15(5):358-60. doi: 10.1097/00005131-200106000-00009.
PubMed 11433141Ye Y, Hao J, Mauffrey C, Hammerberg EM, Stahel PF, Hak DJ. Optimizing Stability in Femoral Neck Fracture Fixation. Orthopedics. 2015 Oct;38(10):625-30. doi: 10.3928/01477447-20151002-05.
PubMed 26488776Collinge CA, Mir H, Reddix R. Fracture morphology of high shear angle "vertical" femoral neck fractures in young adult patients. J Orthop Trauma. 2014 May;28(5):270-5. doi: 10.1097/BOT.0000000000000014.
PubMed 24096307Luttrell K, Beltran M, Collinge CA. Preoperative decision making in the treatment of high-angle "vertical" femoral neck fractures in young adult patients. An expert opinion survey of the Orthopaedic Trauma Association's (OTA) membership. J Orthop Trauma. 2014 Sep;28(9):e221-5. doi: 10.1097/BOT.0000000000000080.
PubMed 25148589
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Functional Outcomes of Internal Fixation Methods for Vertical Femoral Neck Fractures in Young Adult Patients
- ClinicalTrials.gov ID
- NCT04687592
- Acronym / sponsor ID
- Femoral Neck Fractures
- Conditions
- Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 29 Dec 2020 (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.
Does the current techniques of internal fixation of vertical neck fracture in young adult patients give a satisfactory radiological and functional outcome at one year follow up?
Detailed description
- Displaced femoral neck fractures in young adults are most likely to result from high energy trauma that causes a vertically-oriented shearing injury through the femoral neck.
- The most descriptive classification used for femoral neck fractures in young patients is the Pauwels classification. As the degree of the femoral neck fracture line relative to the horizontal plane increases, the types differ (30 degrees type I, between 30 degrees and 50 degrees type II, 50 degrees type III), and the instability of the fracture.
- Greater fracture verticality contributes to greater difficulty in obtaining adequate stability to resist vertical shear forces around the hip, thereby resulting in ascending greater risk of complications such as nonunion and osteonecrosis despite a number of potential fixation strategies.
- The primary goals of surgery include preservation of the femoral head, avoidance of osteonecrosis, and achievement of a stable union.
- Fixation options include cannulated screws, sliding hip screw with or without an additional derotation screw,. among orthopedic trauma surgeons there is no consensus that a single fixation Option is superior for treating these injuries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adults patients with recent vertical femoral neck fracture
Key inclusion criteria (3 listed)
- Age of the patients from 20 to 50 years
Key exclusion criteria (4 listed)
- • Open fractures
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 |
|---|---|---|
| reduction and fixation* Reduction: one trial of closed reduction under anaesthesia and image control. Open reduction will be done by anterolateral or lateral approach if closed reduction failed * Fixation: internal fixation of the fracture by appropriate implant according to the fracture state | Procedure or surgery | – |
Primary outcome
radiological and functional evaluation of the time and rate of union according harris hip score
Time frame: one year
The domains covered in Harris hip score are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication. The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Background: PubMed 17899921Macaulay W, Yoon RS, Parsley B, Nellans KW, Teeny SM; DFACTO Consortium. Displaced femoral neck fractures: is there a standard of care? Orthopedics. 2007 Sep;30(9):748-9. doi: 10.3928/01477447-20070901-08.
- Background: PubMed 11433141Bartonicek J. Pauwels' classification of femoral neck fractures: correct interpretation of the original. J Orthop Trauma. 2001 Jun-Jul;15(5):358-60. doi: 10.1097/00005131-200106000-00009.
- Background: PubMed 26488776Ye Y, Hao J, Mauffrey C, Hammerberg EM, Stahel PF, Hak DJ. Optimizing Stability in Femoral Neck Fracture Fixation. Orthopedics. 2015 Oct;38(10):625-30. doi: 10.3928/01477447-20151002-05.
- Background: PubMed 24096307Collinge CA, Mir H, Reddix R. Fracture morphology of high shear angle "vertical" femoral neck fractures in young adult patients. J Orthop Trauma. 2014 May;28(5):270-5. doi: 10.1097/BOT.0000000000000014.
- Background: PubMed 25148589Luttrell K, Beltran M, Collinge CA. Preoperative decision making in the treatment of high-angle "vertical" femoral neck fractures in young adult patients. An expert opinion survey of the Orthopaedic Trauma Association's (OTA) membership. J Orthop Trauma. 2014 Sep;28(9):e221-5. doi: 10.1097/BOT.0000000000000080.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures, run by Assiut University.
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 3 inclusion and 4 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 29 Dec 2020. 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?
Contact thomas magdi labieb (+201274638308, thomasmagdi22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiological and functional evaluation of the time and rate of union according harris hip score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04687592, which also lists 5 linked publications.
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 29 Dec 2020.