Avascular NecrosisNCT02170545
CT Imaging Evaluation of Humerus Fractures
An observational study of Avascular Necrosis and Humeral Fractures, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Avascular Necrosis, Humeral Fractures
- What is being tested?
- Dual Energy Computed Tomography
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 17 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consenting adult patients with proximal humerus fractures.
Who may be able to join
- Patients with multi-part fracture of proximal humerus.
Who cannot join
- Patients with a humeral head prosthesis, hardware or avascular necrosis in the ipsilateral shoulder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Computed Tomography Evaluation of Humeral Head Perfusion in Displaced Proximal Humerus Fractures in Predicting Rates of Avascular Necrosis
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.
Read the 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:
- 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).
- 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.
- 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.
- 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.
- Conditions
- Avascular Necrosis, Humeral Fractures
- Being tested
- Dual Energy Computed Tomography
- Keywords
- avascular necrosis, humeral head fracture, proximal arm fracture, arthroplasty
- Medical subject headings
- Osteonecrosis, Humeral Fractures, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy Computed TomographyOther
A Dual Energy Computed Tomography scan will be performed on both upper arms.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Part Proximal Humerus Fracture | All participants that meet the entry criteria will be included in the study cohort. Receives: Other: Dual Energy Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 years of fracture correction or surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMar 2014
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avascular NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Hoover, MD, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170545
- Sponsor's protocol ID
- HM20000037
- Status last verified
- Oct 2020
- First submitted
- 6 Jun 2014
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34895190
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Evaluation of Humeral Head Perfusion in Displaced Proximal Humerus Fractures in Predicting Rates of Avascular Necrosis
- ClinicalTrials.gov ID
- NCT02170545
- Acronym / sponsor ID
- HM20000037
- Conditions
- Avascular Necrosis, Humeral Fractures
- Keywords
- avascular necrosis, humeral head fracture, proximal arm fracture, arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-Part Proximal Humerus Fracture | – | Other: Dual Energy Computed TomographyAll participants that meet the entry criteria will be included in the study cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting adult patients with proximal humerus fractures.
Key inclusion criteria (1 listed)
- Patients with multi-part fracture of proximal humerus.
Key exclusion criteria (1 listed)
- Patients with a humeral head prosthesis, hardware or avascular necrosis in the ipsilateral shoulder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Energy Computed TomographyA Dual Energy Computed Tomography scan will be performed on both upper arms. | Other | Multi-Part Proximal Humerus Fracture |
Primary outcome
Evidence of avascular necrosis post humeral head fracture.
Time frame: Within 2 years of fracture correction or surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 34895190Hoover 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Hoover, MD, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Avascular Necrosis and Humeral Fractures, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of avascular necrosis post humeral head fracture. (time frame: Within 2 years of fracture correction or surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.