NCT03666637

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

September 8, 2018

Last Update Submit

September 11, 2018

Conditions

Femoral Neck FracturesAvascular Necrosis

Keywords

Adultavascular necrosisComplicationsDelayed fixationnonunionSurgical timingPauwels

Outcome Measures

Primary Outcomes (2)

  • Incidence of AVN in adult patients with FNF that treated surgically

    In relation to the time of surgery after the fracture

    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

    6 months

Interventions

dynamic hip screw (DHS) and cannulated screw (CS)PROCEDURE

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).

Also known as: Time to fixation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Security Forces Hospital

Riyadh, 12625, Saudi Arabia

Location

Related Publications (11)

  • 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.

    PMID: 28975497BACKGROUND

  • 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.

    PMID: 27265356BACKGROUND

  • 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.

    PMID: 28325670BACKGROUND

  • 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. No abstract available.

    PMID: 29389800BACKGROUND

  • 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. doi: 10.1186/s13018-016-0498-3.

    PMID: 27955672BACKGROUND

  • 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.

    PMID: 26728521BACKGROUND

  • 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.

    PMID: 29536678BACKGROUND

  • 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.

    PMID: 28844681BACKGROUND

  • 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.

    PMID: 7438624BACKGROUND

  • 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. doi: 10.1007/BF02850038.

    PMID: 15727403BACKGROUND

  • 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. doi: 10.1302/0301-620x.86b7.15047.

    PMID: 15446534BACKGROUND

MeSH Terms

Conditions

Femoral Neck FracturesOsteonecrosis

Interventions

deoxyhypusine synthase

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saeed Koaban, FRCS

    Security Forces Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 12, 2018

Study Start

September 15, 2017

Primary Completion

May 20, 2018

Study Completion

September 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

SA(1)