Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion

Avascular Necrosis Clinical Trial

Official title:

The Relationship Between Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666637
• Other study ID #: femoral neck fracture in adult
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2018
• Source: Security Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 development of AVN or nonunion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 1, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Femoral Neck Fractures
• Fractures, Bone
• Necrosis
• Osteonecrosis

Intervention

Procedure:
• dynamic hip screw (DHS) and cannulated screw (CS)
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).

Locations

Country	Name	City	State
Saudi Arabia	Security Forces Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (11)

Calandruccio 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. — View Citation

Chen 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. — View Citation

Frank 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. — View Citation

Hu 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. — View Citation

Karaeminogullari 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. — View Citation

Kazley 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. — View Citation

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. Review. — View Citation

Morrissey 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. — View Citation

Neubauer 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. Review. — View Citation

Shen 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. Review. — View Citation

Upadhyay 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of AVN in adult patients with FNF that treated surgically	In relation to the time of surgery after the fracture	Baseline
Primary	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	6 months