CT Imaging Evaluation of Humerus Fractures
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | March 2014 |
| End Date: | March 2022 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Kevin Hoover, MD, PhD
Phone: 804-828-2842
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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