Recruiting

Operative vs. Nonoperative

Sponsor:

University of Maryland, Baltimore

Code:

NCT07351123

Conditions

Pelvic Fractures

Fragility Fractures of the Pelvis (FFP)

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Surgical stabilization of pelvic fracture

Closed treatment of pelvic fracture

Study Details

Brief summary:

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.

Conditions

Pelvic Fractures

Fragility Fractures of the Pelvis (FFP)

Study ID

NCT07351123

Start date

May 25, 2026

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Surgical stabilization of pelvic fracture

Surgical stabilization of pelvic fracture through placement of orthopaedic hardware.

Closed treatment of pelvic fracture

Pelvic fracture that is treated without surgery and assessed over time through interval radiographs until fracture is healed.

Primary outcome measure

  • Patient Willingness to Enroll in a Trial [ Time Frame: 4 months ]
  • Surgeon Willingness to Randomize Patient Treatment [ Time Frame: 4 months ]
  • Completeness of Patient Centered Outcomes Collected [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

University of Maryland, Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jun 8, 2026

Last verified

Jan, 2026

Keywords

  • Pelvic fracture
  • Fragility fracture of the pelvis
  • Pelvic ring injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-06-08.