Femoral Neck FracturesNCT03666637
Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
An observational study of Femoral Neck Fractures and Avascular Necrosis, run by Security Forces Hospital at 1 site in Saudi Arabia.
Trial summary
One of the most serious sequelae of femoral neck fractures (FNFs) is avascular necrosis (AVN) and nonunion, and this translates to a significant morbidity and mortality. This study was conducted to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Femoral Neck Fractures, Avascular Necrosis
- What is being tested?
- dynamic hip screw (DHS) and cannulated screw (CS)
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Sep 2017to 1 Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * All adult patients aged 18 years old to 70 years old admitted and managed for Femur Neck Fracture during the last 10 years (2007 - 2017) at Security Forces Hospital, Riyadh, Saudi Arabia. * Fresh trauma case including all patients admitted within 24 hours of the injury. * Referred cases including patients referred from other hospitals and patients came from the war zone without time limitation.
Who may be able to join
- All patients included must be adult and aged 18 years old to 70 years old
- admitted and managed for Femur Neck Fracture.
- All fresh trauma and referred cases were included in the study.
Who cannot join
- Patients who have sickle cell disease (SCD), patients who are on steroids, patients who have developmental dysplasia of the hip (DDH), patients who have ipsilateral femoral shaft fracture, immobilized patients, pediatric cases and comatose patients were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
One of the most serious sequelae of femoral neck fractures (FNFs) is avascular necrosis (AVN) and nonunion, and this translates to a significant morbidity and mortality. This study was conducted to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the development of AVN or nonunion.
Read the detailed description
Femoral neck fractures (FNFs) are fractures of the flattened pyramidal bone connecting the femoral head and the femoral shaft. It is not so common in healthy individuals but common among athletes, military recruits, and young adults because of high energy cases such as sports and road traffic accidents, in adults due to falls, in women with estrogen imbalances, and in patients with bone mineralization and deficiencies.
In the USA in 2013, there were a reported 146 cases per 100,000 population. Mortality can be high as much as 30% at one year particularly if there is delaying management over 24 hours.
FNFs are classified using the Garden Classification based on anteroposterior radiographs into Types I to IV wherein Type I is incomplete fracture, Type II is complete but non-displaced fracture, Type III is complete and partially displaced fracture and Type IV is complete and fully displaced femur. Another classification is the Pauwel's classification which is a biomechanical classification based on the vertical orientation of the fracture line, and is commonly used to determine the appropriate treatment for FNFs particularly among younger adults.
The radiographic union score for hip (RUSH) is a scoring used to describe healing of femoral neck fractures, particularly among patients who might require additional surgery, in which patients with a 6-month RUSH score <18 have a greater probability of undergoing reoperation.
Surgical management of FNFs include open reduction and internal fixation (ORIF) which has some fixation failures, primary total hip arthroplasty (TA) which is cost-effective for displaced FNFs in patients 45-65 years old, cannulated screw (CS) fixation for the young and middle-aged patients, dynamic hip screw fixation (DHS), and hemiarthroplasty. The decision to use either of the surgical management depends on several factors including displacement of the femoral neck, presence of hip joint arthritis, age, and other factors. Around 24% of patients who had THA underwent revision within 5 years because of aseptic loosening, infection and many other causes. Some surgeons however prefer ORIF and some prefer THA for displaced FNFs particularly among active older patients with Garden III fracture.
One of the most serious sequelae of FNFs is avascular necrosis (AVN) which occurs in 10-45% of patients with FNFs, particularly those who have displaced and nonunion FNFs. Nonunion occurs in almost 20% of FNFs, more common in men than women, and common with increasing age. Around 33% of displaced FNFs are associated with complications. One study showed that age and the type of fixation are not significantly correlated to the incidence of AVN, but the amount of vascular damage at the time of the fracture determines the development of vascular necrosis. On the other hand, a separate study showed that the fracture type and age are the most significant predictors of the development of AVN.
It has been mentioned that time is essential in the management of FNFs particularly in the development of AVN. One study showed that the rates of AVN increases over time when patients underwent surgery before 12 hours had elapsed and after 12 hours from 12.5% to 14.0%, while another study showed that a delay of more than 48 hours before surgery did not influence the rate of union or the development of AVN when compared with operation within 48 hours of injury. Some studies reported that bleeding from the holes of cannulated screws predict the development of AVN, some due to damage to the blood supply of the femoral head brought about by the initial high energy trauma, and some due to the extent of fracture displacement. Other studies have suggested that FNFs treated using cannulated screws particularly among middle-aged and elderly patients have less incidence of AVN. Because of these, we undertook this study to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the development of AVN or nonunion.
- Conditions
- Femoral Neck Fractures, Avascular Necrosis
- Being tested
- dynamic hip screw (DHS) and cannulated screw (CS)
- Keywords
- Adult, avascular necrosis, Complications, Delayed fixation, nonunion, Surgical timing, Pauwels
- Medical subject headings
- Femoral Neck Fractures, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic hip screw (DHS) and cannulated screw (CS)Procedure or surgery
Also called Time to fixation
A preformed case report form was used to collect the data which included the demographic profile of the patients (age, gender), comorbidities, smoking history, mode of injury (high or low energy), presence of multiple trauma, garden classification, side of injury, time to fixation (in hours), type of reduction, type of implant used, RUSH score (healing), start of weight bearing, development of AVN, and final outcome (whether varus, valgus, displaced or healed).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AVN in adult patients with FNF that treated surgically
In relation to the time of surgery after the fracture
Measured: Baseline
RUSH score (healing)
The radiographic union score for hip (RUSH) is a scoring used to describe healing of femoral neck fractures, particularly among patients who might require additional surgery, in which patients with a 6-month RUSH score <18 have a greater probability of undergoing reoperation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start15 Sep 2017
- Primary completion20 May 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raheef Alatassi, Security Forces Hospital
- Investigators
- Saeed Koaban, FRCS, Study director, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666637
- Sponsor's protocol ID
- femoral neck fracture in adult
- Status last verified
- Sep 2018
- First submitted
- 8 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kemmler W, von Stengel S, Kohl M. Exercise Frequency and Fracture Risk in Older Adults-How Often Is Enough? Curr Osteoporos Rep. 2017 Dec;15(6):564-570. doi: 10.1007/s11914-017-0407-7.
PubMed 28975497Neubauer T, Brand J, Lidder S, Krawany M. Stress fractures of the femoral neck in runners: a review. Res Sports Med. 2016 Jul-Sep;24(3):185-99. doi: 10.1080/15438627.2016.1191489. Epub 2016 Jun 6.
PubMed 27265356Morrissey N, Iliopoulos E, Osmani AW, Newman K. Neck of femur fractures in the elderly: Does every hour to surgery count? Injury. 2017 Jun;48(6):1155-1158. doi: 10.1016/j.injury.2017.03.007. Epub 2017 Mar 6.
PubMed 28325670Kazley JM, Banerjee S, Abousayed MM, Rosenbaum AJ. Classifications in Brief: Garden Classification of Femoral Neck Fractures. Clin Orthop Relat Res. 2018 Feb;476(2):441-445. doi: 10.1007/s11999.0000000000000066. No abstract available.
PubMed 29389800Shen M, Wang C, Chen H, Rui YF, Zhao S. An update on the Pauwels classification. J Orthop Surg Res. 2016 Dec 12;11(1):161. doi: 10.1186/s13018-016-0498-3.
PubMed 27955672Frank T, Osterhoff G, Sprague S, Garibaldi A, Bhandari M, Slobogean GP; FAITH Investigators. The Radiographic Union Score for Hip (RUSH) Identifies Radiographic Nonunion of Femoral Neck Fractures. Clin Orthop Relat Res. 2016 Jun;474(6):1396-404. doi: 10.1007/s11999-015-4680-4.
PubMed 26728521Hu X, Liu BJ, Wen XM, Zheng YH, Jia K. [Clinical observation of closed reduction and compression cannulated screw fixation for the treatment of femoral neck fracture in young and middle-aged patients]. Zhongguo Gu Shang. 2018 Feb 25;31(2):111-114. doi: 10.3969/j.issn.1003-0034.2018.02.003. Chinese.
PubMed 29536678Chen C, Yu L, Tang X, Liu MZ, Sun LZ, Liu C, Zhang Z, Li CZ. Dynamic hip system blade versus cannulated compression screw for the treatment of femoral neck fractures: A retrospective study. Acta Orthop Traumatol Turc. 2017 Oct;51(5):381-387. doi: 10.1016/j.aott.2017.07.006. Epub 2017 Aug 26.
PubMed 28844681Calandruccio RA, Anderson WE 3rd. Post-fracture avascular necrosis of the femoral head: correlation of experimental and clinical studies. Clin Orthop Relat Res. 1980 Oct;(152):49-84.
PubMed 7438624Karaeminogullari O, Demirors H, Atabek M, Tuncay C, Tandogan R, Ozalay M. Avascular necrosis and nonunion after osteosynthesis of femoral neck fractures: effect of fracture displacement and time to surgery. Adv Ther. 2004 Sep-Oct;21(5):335-42. doi: 10.1007/BF02850038.
PubMed 15727403Upadhyay A, Jain P, Mishra P, Maini L, Gautum VK, Dhaon BK. Delayed internal fixation of fractures of the neck of the femur in young adults. A prospective, randomised study comparing closed and open reduction. J Bone Joint Surg Br. 2004 Sep;86(7):1035-40. doi: 10.1302/0301-620x.86b7.15047.
PubMed 15446534
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
- ClinicalTrials.gov ID
- NCT03666637
- Acronym / sponsor ID
- femoral neck fracture in adult
- Conditions
- Femoral Neck Fractures, Avascular Necrosis
- Keywords
- Adult, avascular necrosis, Complications, Delayed fixation, nonunion, Surgical timing, Pauwels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 12 Sep 2018 (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.
One of the most serious sequelae of femoral neck fractures (FNFs) is avascular necrosis (AVN) and nonunion, and this translates to a significant morbidity and mortality. This study was conducted to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the development of AVN or nonunion.
Detailed description
Femoral neck fractures (FNFs) are fractures of the flattened pyramidal bone connecting the femoral head and the femoral shaft. It is not so common in healthy individuals but common among athletes, military recruits, and young adults because of high energy cases such as sports and road traffic accidents, in adults due to falls, in women with estrogen imbalances, and in patients with bone mineralization and deficiencies.
In the USA in 2013, there were a reported 146 cases per 100,000 population. Mortality can be high as much as 30% at one year particularly if there is delaying management over 24 hours.
FNFs are classified using the Garden Classification based on anteroposterior radiographs into Types I to IV wherein Type I is incomplete fracture, Type II is complete but non-displaced fracture, Type III is complete and partially displaced fracture and Type IV is complete and fully displaced femur. Another classification is the Pauwel's classification which is a biomechanical classification based on the vertical orientation of the fracture line, and is commonly used to determine the appropriate treatment for FNFs particularly among younger adults.
The radiographic union score for hip (RUSH) is a scoring used to describe healing of femoral neck fractures, particularly among patients who might require additional surgery, in which patients with a 6-month RUSH score <18 have a greater probability of undergoing reoperation.
Surgical management of FNFs include open reduction and internal fixation (ORIF) which has some fixation failures, primary total hip arthroplasty (TA) which is cost-effective for displaced FNFs in patients 45-65 years old, cannulated screw (CS) fixation for the young and middle-aged patients, dynamic hip screw fixation (DHS), and hemiarthroplasty. The decision to use either of the surgical management depends on several factors including displacement of the femoral neck, presence of hip joint arthritis, age, and other factors. Around 24% of patients who had THA underwent revision within 5 years because of aseptic loosening, infection and many other causes. Some surgeons however prefer ORIF and some prefer THA for displaced FNFs particularly among active older patients with Garden III fracture.
One of the most serious sequelae of FNFs is avascular necrosis (AVN) which occurs in 10-45% of patients with FNFs, particularly those who have displaced and nonunion FNFs. Nonunion occurs in almost 20% of FNFs, more common in men than women, and common with increasing age. Around 33% of displaced FNFs are associated with complications. One study showed that age and the type of fixation are not significantly correlated to the incidence of AVN, but the amount of vascular damage at the time of the fracture determines the development of vascular necrosis. On the other hand, a separate study showed that the fracture type and age are the most significant predictors of the development of AVN.
It has been mentioned that time is essential in the management of FNFs particularly in the development of AVN. One study showed that the rates of AVN increases over time when patients underwent surgery before 12 hours had elapsed and after 12 hours from 12.5% to 14.0%, while another study showed that a delay of more than 48 hours before surgery did not influence the rate of union or the development of AVN when compared with operation within 48 hours of injury. Some studies reported that bleeding from the holes of cannulated screws predict the development of AVN, some due to damage to the blood supply of the femoral head brought about by the initial high energy trauma, and some due to the extent of fracture displacement. Other studies have suggested that FNFs treated using cannulated screws particularly among middle-aged and elderly patients have less incidence of AVN. Because of these, we undertook this study to determine the relationship between the etiologies and management of FNFs in our institution and its relationship to the development of AVN or nonunion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * All adult patients aged 18 years old to 70 years old admitted and managed for Femur Neck Fracture during the last 10 years (2007 - 2017) at Security Forces Hospital, Riyadh, Saudi Arabia. * Fresh trauma case including all patients admitted within 24 hours of the injury. * Referred cases including patients referred from other hospitals and patients came from the war zone without time limitation.
Key inclusion criteria (3 listed)
- All patients included must be adult and aged 18 years old to 70 years old
- admitted and managed for Femur Neck Fracture.
- All fresh trauma and referred cases were included in the study.
Key exclusion criteria (1 listed)
- Patients who have sickle cell disease (SCD), patients who are on steroids, patients who have developmental dysplasia of the hip (DDH), patients who have ipsilateral femoral shaft fracture, immobilized patients, pediatric cases and comatose patients were excluded from the study.
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 |
|---|---|---|
| dynamic hip screw (DHS) and cannulated screw (CS)Also: Time to fixationA preformed case report form was used to collect the data which included the demographic profile of the patients (age, gender), comorbidities, smoking history, mode of injury (high or low energy), presence of multiple trauma, garden classification, side of injury, time to fixation (in hours), type of reduction, type of implant used, RUSH score (healing), start of weight bearing, development of AVN, and final outcome (whether varus, valgus, displaced or healed). | Procedure or surgery | – |
Primary outcome
Incidence of AVN in adult patients with FNF that treated surgically
Time frame: Baseline
In relation to the time of surgery after the fracture
RUSH score (healing)
Time frame: 6 months
The radiographic union score for hip (RUSH) is a scoring used to describe healing of femoral neck fractures, particularly among patients who might require additional surgery, in which patients with a 6-month RUSH score <18 have a greater probability of undergoing reoperation
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 13 Sep 2018.
- Background: PubMed 28975497Kemmler W, von Stengel S, Kohl M. Exercise Frequency and Fracture Risk in Older Adults-How Often Is Enough? Curr Osteoporos Rep. 2017 Dec;15(6):564-570. doi: 10.1007/s11914-017-0407-7.
- Background: PubMed 27265356Neubauer T, Brand J, Lidder S, Krawany M. Stress fractures of the femoral neck in runners: a review. Res Sports Med. 2016 Jul-Sep;24(3):185-99. doi: 10.1080/15438627.2016.1191489. Epub 2016 Jun 6.
- Background: PubMed 28325670Morrissey N, Iliopoulos E, Osmani AW, Newman K. Neck of femur fractures in the elderly: Does every hour to surgery count? Injury. 2017 Jun;48(6):1155-1158. doi: 10.1016/j.injury.2017.03.007. Epub 2017 Mar 6.
- Background: PubMed 29389800Kazley JM, Banerjee S, Abousayed MM, Rosenbaum AJ. Classifications in Brief: Garden Classification of Femoral Neck Fractures. Clin Orthop Relat Res. 2018 Feb;476(2):441-445. doi: 10.1007/s11999.0000000000000066. No abstract available.
- Background: PubMed 27955672Shen M, Wang C, Chen H, Rui YF, Zhao S. An update on the Pauwels classification. J Orthop Surg Res. 2016 Dec 12;11(1):161. doi: 10.1186/s13018-016-0498-3.
- Background: PubMed 26728521Frank T, Osterhoff G, Sprague S, Garibaldi A, Bhandari M, Slobogean GP; FAITH Investigators. The Radiographic Union Score for Hip (RUSH) Identifies Radiographic Nonunion of Femoral Neck Fractures. Clin Orthop Relat Res. 2016 Jun;474(6):1396-404. doi: 10.1007/s11999-015-4680-4.
- Background: PubMed 29536678Hu X, Liu BJ, Wen XM, Zheng YH, Jia K. [Clinical observation of closed reduction and compression cannulated screw fixation for the treatment of femoral neck fracture in young and middle-aged patients]. Zhongguo Gu Shang. 2018 Feb 25;31(2):111-114. doi: 10.3969/j.issn.1003-0034.2018.02.003. Chinese.
- Background: PubMed 28844681Chen C, Yu L, Tang X, Liu MZ, Sun LZ, Liu C, Zhang Z, Li CZ. Dynamic hip system blade versus cannulated compression screw for the treatment of femoral neck fractures: A retrospective study. Acta Orthop Traumatol Turc. 2017 Oct;51(5):381-387. doi: 10.1016/j.aott.2017.07.006. Epub 2017 Aug 26.
- Background: PubMed 7438624Calandruccio RA, Anderson WE 3rd. Post-fracture avascular necrosis of the femoral head: correlation of experimental and clinical studies. Clin Orthop Relat Res. 1980 Oct;(152):49-84.
- Background: PubMed 15727403Karaeminogullari O, Demirors H, Atabek M, Tuncay C, Tandogan R, Ozalay M. Avascular necrosis and nonunion after osteosynthesis of femoral neck fractures: effect of fracture displacement and time to surgery. Adv Ther. 2004 Sep-Oct;21(5):335-42. doi: 10.1007/BF02850038.
- Background: PubMed 15446534Upadhyay A, Jain P, Mishra P, Maini L, Gautum VK, Dhaon BK. Delayed internal fixation of fractures of the neck of the femur in young adults. A prospective, randomised study comparing closed and open reduction. J Bone Joint Surg Br. 2004 Sep;86(7):1035-40. doi: 10.1302/0301-620x.86b7.15047.
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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.
Saeed Koaban, FRCS study director
Security Forces Hospital
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 Femoral Neck Fractures and Avascular Necrosis, run by Security Forces Hospital at 1 site in Saudi Arabia.
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 1 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 13 Sep 2018. 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 Saudi Arabia. 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?
Incidence of AVN in adult patients with FNF that treated surgically (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT03666637, which also lists 11 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 13 Sep 2018.