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Title
Summary
A significant subset of patients with
scapula fractures also involves the glenoid neck (bone joining the shoulder
joint the scapular body). There is little evidence pertaining to the best
treatment or precise definition of these lesions. This study will be
designed as a prospective, non-randomized cohort study that will collect
outcome and radiological data on patients who have sustained a fracture of
the glenoid neck (bone joining the shoulder joint the scapular body) for a
period of 1 year. All patients who have sustained extraarticular scapula
fractures (any fracture not involving the glenoid surface) will be
considered. Information will be collected with respect to the radiographic
characteristics of osseous injuries as well as functional outcome over time.
The goal is to determine if functional outcome correlates with the degree of
bony injury. The null hypothesis is that once the fracture healing has
occurred, forelimb function is not impacted by a fracture of the glenoid
neck, regardless of radiographic osseous derangement. Specifically, we hope
to compare outcomes following glenoid neck fracture against lesions of the
scapular body to determine if significant osseous injury to this particular
area impacts forelimb function to a greater degree than body fractures. The
proposed study may serve as a pilot for a subsequent, multicenter effort,
where mean and standard deviation data obtained will be used for a power
analysis if future research involves any intervention.
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Research Design
Design:
Observational, prospective
This prospective, non randomized study will evaluate extraarticular scapula
fractures involving the glenoid neck as compared to both non-glenoid
scapular fractures and the uninjured contralateral shoulder girdle.
Patients will be initially identified by the PI and or designed staff for
potential inclusion based on the aforementioned lesions being seen on
radiographs, including plain x-rays and CT. Presenting radiographs will be
assessed according to a tripartite measurement protocol specifically
quantifying: 1) glenoid medialization, 2) glenopolar angle and 3) scapular
shortening, each as either absolute values or a ratio to the contralateral
scapula. Patients are not blinded or randomized.
Analysis: Patients sustaining glenoid neck fractures will be compared to
those sustaining scapular body fractures to ascertain any functional
difference owing to osseous lesion when the soft tissues are similarly
traumatized. Then, the functional capacity of an extremity compromised by a
glenoid neck fracture will be compared to the contralateral, uninjured
extremity according to strength testing and the above outcome measures.
Strength testing will be pursued using an objective measuring device such as
a goniometer and range of motion data will be recorded. From these data sets
pairing osseous injury and functional outcome, mean and standard deviation
values will be extrapolated towards construction of a prospective
multicenter analysis. A parallel analysis will concern the proposed
radiograph measurements, as they will be objectively assessed for precision.
At the present time, the magnitude of difference that may be observed in
both the outcome measures and radiographic characterization is unknown.
Furthermore, there are no analogous studies in the literature from which to
extrapolate an estimation of power. We plan to enroll 50 patients within the
above-outlined context, with an enrollment horizon of a maximum of two
years. With a scheduled follow-up evaluation period of one year, the
proposed study timeframe is projected to be three years.
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Outcomes
This is a prospective study for
which there is no precedent outcome data in the available literature. The
scapular fractures will thus be considered a cohort comprised of two a
priori subgroups (scapular body and glenoid neck) which we believe may be
functional different and thus we are leaving open the possibility that they
will show a difference. We will analyze scapular fractures as a group for
functional outcomes and compare the outcomes of scapular body against
glenoid neck fractures. We will also attempt to correlate the degree of
osseous derangement of a fracture as measured on radiographs with the scores
on the 3 respective outcome measures and clinical extremity testing.
Direct measurement of radiographs will take place at the time of initial
presentation and at the scheduled follow-up visits. The values will be
recorded either as absolute values or ratios to the contralateral extremity.
Patients will be evaluated for functional outcome via the DASH/SMF/ASES at
scheduled follow-up visits.
Gross comparison of the degree of osseous derangement of the glenohumeral
joint to functional outcome will take place. With multiple variables being
examined on each side of the analysis, the first step will be to consider
the existent data and define a single variable of interest. This will likely
involve a separate consideration of the three radiographic injury parameters
to the observed functional outcomes; the latter being considered as a
continuous variable. Student-t, Chi-squared and analysis of variance will be
used to evaluate continuous variables, proportions and multiple variables
respectively. The glenoid neck injured group will then be compared in
aggregate against those patients sustaining a scapular body fracture in
terms of strength and validated functional outcome scores. Both cohorts will
have the putatively uninjured contralateral extremity examined for strength.
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Inclusion Criteria
- Adults 18-65 and 65+
- Extraarticular scapular
fractures
- Scapular fracture is
isolated or in concert with nondisplaced ipsilateral fractures of the
clavicle, coracoid or acromion
- Patient is free of
preexisting neuromuscular or psychiatric dysfunction
- Patient is free of
previous upper extremity injury that would impede objective functional
outcome evaluation
- Patient is English
speaking
- Patient is signed the
informed consent form
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Exclusion Criteria:
- Preexisting upper
extremity injury or neuromuscular condition
- Displaced fractures of
the acromion, clavicle, or coracoid
- Concomitant injury to
the forelimb
- Patients mentally or
physically unable to perform the function evaluation
- Patients unwilling or
unable to follow up for 1 year
- Patients with poor
propensity to follow up; drug, alcohol issues, etc.
- Non English speaking
patients
- Patients currently or
pending incarceration in prison
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