Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus Nonoperative Care with Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: a Pilot Study

YJ

Yohan Jang

Principal Investigator

Status: Enrolling By Invitation Ages: 60 Years - 100 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

The overall goal of this research is to determine if early surgical treatment is more effective than nonoperative care and early rehabilitation at lowering the risk of complications in patients with pelvis fractures. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with <10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - The orthopaedic trauma team meets every morning to discuss the patients under orthopaedic care. Patients will be screened for study enrollment at that meeting. Patients with qualifying injuries will be flagged as potential candidates and further medical record review will be conducted by the study team. Patients or their legally authorized representatives will be approached in the hospital in a private room about study participation.

Detailed Description

Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Patients will be followed for 1 year, with visits occurring at 2 weeks, 6 weeks, 4 months, 8 months, and 1 year after fracture. At each follow-up, mortality, ambulation, healthy days at home, and health status will be collected.

The primary objective is to assess feasibility of the trial and to collect information to inform the design of the definitive trial. The feasibility outcomes will include participant enrollment, adherence to treatment allocation, data collection methods, and compliance with key aspects of the protocol.

Eligibility of study

Inclusion Criteria:

  1. Patient 60 years of age or older.
  2. Low energy injury mechanism defined as a fall from standing height.
  3. LC1 pelvis fracture (AO/OTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.
  4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.
  5. Fracture displacement of <10 mm of the posterior pelvic ring on computed tomography of the pelvis.
  6. Injury occurred within 21 days of screening.

Exclusion Criteria:

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.