CT Imaging Evaluation of Humerus Fractures

NCT02170545 | Completed

• 1 other identifier: HM20000037
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Avascular Necrosis; Humeral Fractures

Keywords

avascular necrosis; humeral head fracture; proximal arm fracture; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Evidence of avascular necrosis post humeral head fracture.

  All patients who have humeral head fractures will have a dual energy CT examination performed with intravenous contrast to evaluate the fracture pattern to determine if the patient is a surgical candidate. The amount of contrast within the fractured humeral head will be measured on this CT scan as a surrogate for blood flow. After conservative (no surgery) or surgical (open reduction internal fixation) treatment, the patient will be followed in the orthopedics clinic for two years. During each twice yearly visit, shoulder radiographs will be obtained. Standardized criteria for radiograph assessment to determine AVN will be used: mixed lucent and sclerotic appearance of the humeral head, subchondral collapse as indicated by a "crescent sign" and/or loss of humeral head sphericity. AVN will be described as present or absent based on the radiographic findings. The incidence of AVN will be correlated with the amount of contrast within the humeral head as measured by dual energy CT.

  Within 2 years of fracture correction or surgery.

Study Arms (1)

Multi-Part Proximal Humerus Fracture

All participants that meet the entry criteria will be included in the study cohort.

Other: Dual Energy Computed Tomography

Interventions

Dual Energy Computed Tomography OTHER

A Dual Energy Computed Tomography scan will be performed on both upper arms.

Multi-Part Proximal Humerus Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting adult patients with proximal humerus fractures.

You may qualify if:

• Patients with multi-part fracture of proximal humerus.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 34895190 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

For those patients who undergo shoulder replacement, the humeral head bone will be collected and processed for any evidence of avascular necrosis. Once processing and data collection is done, the bone will be disposed of.

MeSH Terms

Conditions

Osteonecrosis; Humeral Fractures; Shoulder Fractures

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arm Injuries; Wounds and Injuries; Fractures, Bone; Shoulder Injuries

Study Officials

• Kevin Hoover, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 23, 2014
• Study Start: March 1, 2014
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (1)