Virtual Mechanical Testing of Humeral Fracture Healing and Nonunion
R
Roman Natoli, MD
Primary Investigator
Overview
This study will examine whether the stiffness of a partially healed bone, measured using a 3D image and computer simulation constructed from a CT scan can predict at a very early stage if there are problems with how the bone is healing.
Description
This study is open to participants who are in the "Serum Protein-Based Indices for the Progression of Fracture Healing and Nonunion" study. Researchers will take one low-dose CT scan 8-10 weeks after participants' injuries. Researchers will also receive some health history information from the participants' medical records.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Fracture
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Age: Between 18 Years - 70 Years
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Gender: All
Inclusion Criteria:
- Enrolled in the parent study (“Serum Protein-Based Indices for the Progression of Fracture Healing and Nonunion”)
- Skeletally mature, based on appearance of growth plate. Skeletal maturity is typically achieved by age 18 in males and age 16 in females, however additional radiographic assessment of the humerus growth plate closure will be used to assess skeletal maturity.
- Closed extra-articular fracture of the mid-diaphyseal humerus with complete AP and lateral radiographs
- Fractures requiring non-operative treatment
- Informed consent obtained
- Participant speaks English
Exclusion Criteria:
- Closed humerus shaft fractures that are not able to be fixed non-operatively
- Concomitant vascular injury or severe soft injury
- Open fractures
- Floating elbow
- Concomitant displaced humeral articular injuries
- Pathologic fractures
- Surgical delay greater than 1 weeks for closed fractures
- Immunocompromised
- Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured, mentally impaired, paralysis)
- Retained hardware or existing deformity in the affected limb that would complicate treatment
- Current or impending incarceration
- Unlikely to follow-up in surgeon's estimation (the subject lives very far from the facility and the likelihood of follow-up is slim or the subject is not sure they want to participate, etc.)
- Known metabolic bone disease
- Symptomatic arthritis
- Contralateral fractures (bilateral injury, lower extremity injury, head injury other polytrauma that would compromise serum measurements)
- Pregnant women or potentially pregnant women
Updated on
07 May 2024.
Study ID: 14869, ORTHO-OTA-HUMERAL
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