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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR086467-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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Fragility fractures of the pelvic ring are a common injury associated with poor patient outcomes and high healthcare costs. Management of these injuries is evolving with increasing frequency of operative stabilization of the pelvic ring, despite a lack of evidence supporting operative versus nonoperative treatment. This multicenter prospective cohort study will evaluate 120 patients to determine the feasibility of a randomized controlled trial comparing operative and nonoperative treatment, by evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
Fragility fractures of the pelvic ring are a common injury that is increasing in incidence with an aging population. These injuries are associated with high healthcare costs and poor patient outcomes, including decline in ambulatory function, decreased independence, and a one-year mortality of 11-27%. Historically, older adults with fragility fractures of the pelvis received nonoperative treatment with supportive care because operative management was deemed too invasive for this patient population. However, the development of percutaneous and less invasive surgical techniques has led to an increased frequency of operative stabilization of pelvis fractures in older adults. It is unclear if the increasing use of surgical fixation is improving outcomes for patients with pelvic fragility fractures. There are significant limitations with the current body of evidence that precludes its ability to guide clinical practice. Randomized controlled trials testing the efficacy of operative management are urgently needed to determine when surgical fixation is warranted.
Two pilot randomized controlled trials have been performed on this patient population, and both have not progressed to a definitive study citing a lack of recruitment feasibility. This is due to both the lack of agreement amongst surgeons for which patients should receive randomized treatment, as well as a lack of patient willingness to enroll in a trial. Furthermore, loss to follow up is a concern in both the orthopaedic trauma population and in older adult study patients. This prospective cohort study will evaluate 120 patients from six hospitals to determine the feasibility of a randomized controlled trial (RCT) comparing operative versus nonoperative management of fragility fractures of the pelvic ring. This will be accomplished by three aims evaluating patient willingness to enroll in a trial, surgeon willingness to randomize their patients' treatment, and the completeness of data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Patients aged 60 years and older with a low energy mechanism closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical stabilization of pelvic fracture | Procedure | Surgical stabilization of pelvic fracture through placement of orthopaedic hardware. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Willingness to Enroll in a Trial | Willingness to enroll in a trial will be assessed as a binary variable with the central three choices representing that the participant is willing to have their treatment randomized. | 4 months |
| Surgeon Willingness to Randomize Patient Treatment | Surgeon willingness to enroll the patient in the trial will be assessed as a binary variable with the central three choices representing that the surgeon would have been willing to have their treatment decision randomized. | 4 months |
| Completeness of Patient Centered Outcomes Collected | The outcome measure completion will be assessed as a binary variable classified as either complete documentation or missing documentation. | 4 months |
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The inclusion criteria are:
The exclusion criteria are:
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Patients ≥ 60 years of age with a closed pelvic ring fracture with an anterior and posterior injury observable on x-ray or CT scan.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Gage, MD | Contact | 410-328-1868 | mgage@som.umaryland.edu | |
| Heather Phipps, MPS | Contact | hphipps@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark Gage, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
The Final Research Data set of validated de-identified data will include discrete data elements supporting the primary and secondary endpoints. Demographic, injury, clinical results data will be acquired from pelvis fracture subjects. All data will be de-identified prior to receipt by the National Trauma Research Repository (NTRR).
Data will be made available to the research community as soon as possible, but no later than one year after publication of the initial study manuscript. All data will be kept in the NTRR for at least five years after the initial study publication.
All data and associated study materials will be submitted to the NTRR. The NTRR is built on the Biomedical Research Information Computing System (BRICS) platform developed by the Center for Information Technology at the National Institutes of Health (NIH). The NTRR platform and processes meet the NIH Grant Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources Principles and Guidelines for Recipients of the NIH Grants and Contracts.
Data will be findable for the research community through the NTRR. The NTRR assigns a unique digital object identifier (DOI) for each data set submitted. This DOI, as a persistent unique identifier, can be used to reference the data set in manuscripts. Data stored in the NTRR meets FAIR principles (findable, accessible, interoperable, and re-usable).
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Closed treatment of pelvic fracture | Other | Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed. |
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| D007869 |
| Leg Injuries |