Clinical trial NCT02170545: CT Imaging Evaluation of Humerus Fractures
Official title: Computed Tomography Evaluation of Humeral Head Perfusion in Displaced Proximal Humerus Fractures in Predicting Rates of Avascular Necrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avascular Necrosis
Humeral Fractures
Keywords: avascular necrosis
humeral head fracture
proximal arm fracture
arthroplasty
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consenting adult patients with proximal humerus fractures.

Brief summary: Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge for patients and orthopedic surgeons. Proximal humerus fractures represent the third most common fracture after hip and distal radius fractures, and more than 20% of these fractures meet operative indications. Unfortunately, one of the major complications of these fractures is the development of avascular necrosis (AVN), or death of the bone as a result of the loss of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this study is to determine if computed tomography imaging can identify a quantifiable predictor of AVN following this type of humeral fracture.

Detailed description: Current surgical treatment of humeral head fracture does not follow a universally accepted treatment algorithm. Treatment guidelines are lacking sufficient prospective controlled evidence to support any one option as doctrine. However, the generally accepted dogma regarding the surgical treatment of fractures considered high-risk for Avascular Necrosis (AVN), and also symptomatic avascular necrosis of the humeral head, is shoulder replacement (arthroplasty). This is a difficult scenario for younger patients where humeral head preservation is the priority, because of a expected lifespan that will require one, if not multiple, arthroplasty revisions. There is data suggesting no difference in functional outcome for complx humeral head fractures treated with open reduction and internal fixation (ORIF), that late progress to AVN, and patients who undergo hemi-arthroplasty, because of risk of AVN. However, failure of surgery related to AVN remains a challenging problem often leading to secondary surgery, which is not without negative outcomes. This study is aimed at trying to come up with a predictor that can be applied to patients prior to initial humeral head fracture treatment.

The specific aims of the study to help determine this predictor are:

1. In patients who have humeral head fracture, evaluate the difference in fracture fragment enhancement in multi-part fractures, by comparing the fracture fragment attenuation on iodine map overlay to the non-traumatized, contralateral humeral head using Dual Energy Computed Tomography (DECT).
2. In patients undergoing ORIF or joint replacement for humeral head fracture without known risk factors for AVN, identify the relationship between the attenuation due to iodine in the fractured humeral head, as measured preoperatively by DECT, with the presence of pulsatile blood flow in the humeral head intra-operatively, as measured with laser doppler.
3. In patients undergoing joint replacement for humeral head fracture without other known risk factors for AVN, identify the relationship between the attenuation due to iodine in the fractured humeral head, as measured preoperatively by DECT, with the presence of AVN in humeral head pathology specimen.
4. In patients who underwent ORIF for humeral head fracture without other known risk factors for AVN, identify the relationship between the attenuation due to iodine within the fractured humeral head, as measured preoperatively by DECT, with the incidence of radiographically apparent AVN after 2 years of clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with multi-part fracture of proximal humerus.

Exclusion Criteria:

* Patients with a humeral head prosthesis, hardware or avascular necrosis in the ipsilateral shoulder.

Primary outcomes:
measure: Evidence of avascular necrosis post humeral head fracture.
timeFrame: Within 2 years of fracture correction or surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Kevin Hoover, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoover KB, Starks AO, Robila V, Riddle DL. Quantitative contrast enhanced dual energy CT to predict avascular necrosis: a feasibility study of proximal humerus fractures. BMC Med Imaging. 2021 Dec 11;21(1):191. doi: 10.1186/s12880-021-00717-x.