FemNeckORvCRIF/morsheds/FINAL
Title:
A Multicenter Retrospective Outcome Assessment of Open Reduction Internal
Fixation (ORIF) vs. Closed Reduction Internal Fixation (CRIF) in Treatment of Adults
with Femoral Neck Fractures.
Abstract:
While the majority of femoral neck fractures are low energy injuries affecting the
elderly population, in younger patients these fractures result from high-energy
trauma and are associated with high risk of complications, including nonunion and
avascular necrosis of the femoral head, often requiring additional surgeries. Joint
preservation is the goal in this younger population. Numerous risk factors for
failure of initial operative fracture repair have been identified including posterior
comminution of the femoral neck, degree of initial displacement, obliquity of the
primary fracture line, and perhaps most importantly, the quality of reduction.
However, the therapeutic effect of an open reduction, which would ostensibly serve
to optimize reduction quality, has not been proven in the literature. We propose a
study to determine differences in clinical outcomes and surgical complications
associated with open reduction and internal fixation (ORIF) versus closed reduction
and internal fixation (CRIF) with a minimum of two years of follow-up. Data
collected will include information on type of injury, type of reduction, quality of
reduction, operative approach, surgical and medical complications and rate and type
of re-operations. Subjects with less than two years of follow-up will be contacted to
return to clinic for radiographic and clinical evaluation. The comparative
effectiveness of open versus closed reduction and internal fixation will be assessed
based on a primary outcome of reoperation rates at 2 years.
Specific Aims:
The best available evidence on superiority of ORIF versus CRIF in treatment of
femoral neck fractures is inconclusive. Our null hypothesis is that there are no
differences in rates of reoperation and of complications between ORIF and CRIF of
femoral neck fractures in adults. Given this hypothesis, we formulate the following
specific aims:
Specific Aim 1: Compare the rate of reoperation following the initial ORIF
versus CRIF of displaced femoral neck fractures in adults as the primary
outcome. Incidence and timing of a defined set of complications, including fracture
nonunions, avascular necrosis, surgical site infections, refractures, periprosthetic
fractures, chondrolysis and lateral femoral cutaneous nerve palsy and number and
types reoperations associated with each will be determined during a minimum two
year postoperative follow-up. Stratified analysis by obliquity of the primary
fracture line (Pauwel’s Class) will be performed. Secondary outcomes will include
individual complications leading to reoperation.
Specific Aim 2: Test the association between measured risk factors for
reoperation, including surgical approach, and complication requiring surgery
after operative management of displaced femoral neck fracture. Multivariable
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regressions will be fit to the data to assess relative contributions of independent
risk factors to the incidence of reoperation. A predictive model will be developed
based on these analyses. Assess the magnitude of effect of surgical approach
mediated by quality of reduction achieved.
Specific Aim 3: To determine the reliability and validity of radiographic
measurements of femoral neck fracture severity and quality of reduction.
Assess inter-rater reliability between site investigators and blinded central
adjudicators. Measure content and construct validity of measures of injury severity
and quality of reduction
Background/Significance:
Femoral neck fractures are a major cause of morbidity and substantial health-care
cost in the United States. There are more than 250,000 cases of hip fractures in the
United States annually with an overwhelming majority of these fractures occurring
in the elderly. 1,2 Mortality associated with femoral neck fractures has been reported
to be as high as 30% during the first year post-injury. 3,4 Intracapsular hip fractures
have an incidence of approximately 3% in patients under the age of fifty5 and are
usually associated with more severe and higher energy injuries compared to older
patients. 6 Femoral neck fractures in the young adult population are associated with
a high complication rate with the two most common being non-union and avascular
necrosis (AVN). 7-12 More severe disruption of femoral head’s blood supply
associated with higher energy injuries has been proposed as a possible reason for
higher risk of nonunion and AVN in this age group. 10
Although there is strong evidence supporting the use of arthroplasty in treatment of
displaced femoral neck fractures (Garden type III or IV) in the elderly population,1315 surgical variables including optimal type of reduction, surgical approach and
timing of operation in treatment of displaced femoral neck fractures in younger
patients remain controversial. 16 In this age group preservation of the femoral head
is a major goal of treatment therefore obtaining adequate reduction with stable
fixation is crucial for success. 12,18,19 However, whether ORIF versus CRIF of these
fractures lead to better clinical outcomes remains controversial. 8-10,17 Many
hypothesize that an open reduction will lead to lower complication and reoperation
rates by way of an anatomic reduction, however this assumption has not been
verified. The findings of this study will help elucidate whether either surgical
approach is superior in terms of clinical outcomes and rate of complications. The
results will be valuable to orthopaedic surgeons in clinical decision-making for
treatment of femoral neck fractures in young adults.
Study Design:
This study is a multicenter retrospective review of medical and radiographic
records from the time of injury through a minimum follow-up of two years
postoperative.
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Study Population:
The study population will consist of patients between the ages of 18 and 65 with
femoral neck fracture initially treated after January 1st, 2000.
Inclusion criteria:
1. Patient was between the ages of 18 – 65 at the time of injury
2. Patient had a displaced femoral neck fracture (OTA Type 31-B2, 31-B3)
3. Patient underwent operative fracture repair of a traumatic femoral neck
fracture after January 1st , 2000.
4. Patient is at least two years from date of operative repair of femoral neck
fracture
Exclusion criteria:
1.
2.
3.
4.
5.
Ipsilateral femoral head fractures
Ipsilateral acetabular fractures
Pathologic fractures
Stress fracture or non-displaced femoral neck fracture
Patients underwent total hip arthroplasty or hemiarthroplasty as initial
treatment of their femoral neck fracture.
Study procedures:
Retrospective review of medical records will be conducted by a research assistants
or suitably trained alternative (medical student, etc) at each participating center.
Eligible patients will be identified based on the aforementioned inclusion and
exclusion criteria. Hospital orthopaedic trauma databases, where available, will be
queried for OTA Type 31 fractures over the study period and cross-referenced with
billing records for CPT codes 27235, 27236, 27244, 27245, 27248, and 27269.
Operative records, pre- and post operative anterior-posterior pelvic and lateral hip
radiographs on any patient meeting any of the above criteria will be screened by the
site principal investigator (PI) for inclusion. Medical and radiographic data related
to the femoral neck fracture will be extracted, including initial hospitalization,
related re-hospitalizations and clinic visits. Radiographic assessments will be done
by the site PI at each center that will include initial injury assessment (fracture
classification by OTA classification and Pauwels), assessment of the quality of
reduction postoperatively and assessment of fracture healing at most recent followup using the RUSH. Patients will be contacted to return for a clinical visit billed as
standard of care, with radiographs, unless they have these data at a minimum of two
years post-injury. Where visual analog pain score and return to work status are
documented, they will be recorded. If the patient is unable to return for any reason
but can be contacted by phone or email, an assessment of any complications, pain
score (0 – 10) and work status will be recorded and the last available radiograph
will be used for the RUSH assessment. In order to evaluate the reliability of fracture
classification, quality of reduction, and RUSH scoring, blinded investigators remote
from the treatment site will review all pertinent radiographs.
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Data Collection:
The following data will be collected for each patient:
1. Patient age, sex, ethnicity and race
2. Past medical history
3. Social History/health-related behaviors, including smoking, alcohol use,
and injection drug use
4. Radiographic assessment of the initial injury which includes fracture
classification (OTA and Pauwels classification) and presence of posterior
comminution
5. Associated injuries, including femoral shaft and supracondylar femur
fractures
6. Operative data, including time of surgery from injury, open versus closed
reduction (as well as whether a closed reduction was initially attempted
and unsuccessful prompting an open approach), surgical approach, type
of fixation and performance of capsulotomy
7. Radiographic assessment of quality of reduction using postoperative
radiographs for measurement of neck shaft angle20, anterior/posterior
angulation after reduction, and restoration of medial cortex
8. Most recent follow-up assessment, including surgical complications, time
of diagnosis of complications, and type of revision surgeries. Recorded
complications include fracture nonunions, avascular necrosis of the
femoral head, superficial and deep surgical site infections, refractures,
periprosthetic fractures, chondrolysis and lateral femoral cutaneous
nerve palsy
9. Quality of life measures, including work status and visual-analog pain
scale (where documented)
10. Radiographic Union Score for Hip (RUSH) at most recent follow-up.
Data Analysis:
Descriptive statistics of patient characteristics will be provided in means and
proportions. Appropriate bivariable parametric and non-parametric analyses will
be conducted to determine the association between surgical approach (open versus
closed), predictor variables, and outcomes (reoperation, complications, VAS, return
to work). Variables with significant (p<0.2) associations with outcome will be
tested in a multivariable logistic regression as independent variables. Inverse
probability of treatment weighting (IPTW) will be used to adjust for confounding
variables. Multivariable proportional hazards models will similarly be constructed
to account for the non-normal distribution of time to failure requiring reoperation.
In the event of greater than 80% loss to follow up in less than two years, a predictive
model of censoring will be used to adjust the IPTW model for selection bias.
Because this is a retrospective observational study meant to improve upon the
sparse extant data on this research question, proper samples size and power
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calculations are not possible. However, the results of this work will be pivotal in
making such calculations for future prospective trials.
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