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Scapula Fracture Outcomes

 

1.  IMPRESS

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2.  SOLVED

Open and Enrolling

Paul Tornetta

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3.  rhBMP-2

6 Centers

Bill Ricci

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4.  Femur Outcomes

Andy Schmidt

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5.  Damage Control

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Inclusion Criteria

6. Sacral Fractures

NCT00644813  

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7.  Ankle Plating

8. Scapula Fractures

 

Title

 

CLINICAL OUTCOMES FOLLOWING GLENOID NECK FRACTURE AS CORRELATED WITH QUANTITATIVE ASSESSMENT OF OSSEOUS INJURY

 

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

 

  1. Adults 18-65 and 65+
  2. Extraarticular scapular fractures
  3. Scapular fracture is isolated or in concert with nondisplaced ipsilateral fractures of the clavicle, coracoid or acromion
  4. Patient is free of preexisting neuromuscular or psychiatric dysfunction
  5. Patient is free of previous upper extremity injury that would impede objective functional outcome evaluation
  6. Patient is English speaking
  7. Patient is signed the informed consent form

 

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Exclusion Criteria:

 

  1. Preexisting upper extremity injury or neuromuscular condition
  2. Displaced fractures of the acromion, clavicle, or coracoid
  3. Concomitant injury to the forelimb
  4. Patients mentally or physically unable to perform the function evaluation
  5. Patients unwilling or unable to follow up for 1 year
  6. Patients with poor propensity to follow up; drug, alcohol issues, etc.
  7. Non English speaking patients
  8. Patients currently or pending incarceration in prison

 

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