Assessment of Treatment Variability for Pelvic Ring Fragility Fractures (Pelvis ATV)

University of Maryland Baltimore (UMB)

Status: Begins enrollment this month

Conditions: Pelvic Fractures; Fragility Fractures of the Pelvis (FFP)

Treatments: Other: Closed treatment of pelvic fracture; Procedure: Surgical stabilization of pelvic fracture

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT07351123

1R01AR086467-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria are:

1. Patient 60 years of age or older.
2. Low energy injury mechanism.
3. LC1 pelvis fracture (AO/OTA 61B1.1,61B2.1, or 61B3.2) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
4. Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
5. Injury occurred within 21 days of screening.

The exclusion criteria are:

1. Patient did not ambulate prior to injury.
2. Severely frail patients (Clinical Frailty Scale ≥7).
3. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.
4. Retained implants around the pelvis that precludes or limits either study treatment.
5. Infection around the hip (soft tissue or bone).
6. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.
7. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.
8. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.
9. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
10. Expected injury survival of less than 12 months.
11. Terminal illness with expected survival of less than 12 months.
12. Currently enrolled in a study that does not permit co-enrollment.
13. Prior enrollment in the study.
14. Unable to obtain informed consent due to language barriers.
15. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.
16. Did not provide informed consent (declined participation).
17. Patient or LAR not approached to participate in the trial (missed patient).
18. Other reason to exclude the patient, as approved by the Principal Investigator.

Trial design

120 participants in 1 patient group

Patient

Description:

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

Treatment:

Procedure: Surgical stabilization of pelvic fracture

Other: Closed treatment of pelvic fracture