Geriatric Lateral Compression 1 Pelvic Fractures

June 12, 2025 updated by: HealthPartners Institute

Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial

Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and/or MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.

  1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture
  2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Allina, Mercy Hospital
        • Contact:
      • Saint Louis Park, Minnesota, United States, 55426
      • Saint Paul, Minnesota, United States, 55101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients >/= 60 years of age
  • Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and/or MRI
  • Low energy mechanism of injury or an insufficiency fracture without a precipitating event
  • Acute injury within four weeks of presentation
  • Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed "Up & Go" (TUG) assessment, or inability to complete the TUG assessment.

Exclusion Criteria:

  • Dementia
  • Vertically or rotationally unstable pelvic ring injuries
  • Pathologic fracture secondary to tumor
  • Non-ambulatory prior to injury
  • Acute neurologic deficit
  • High-energy mechanism of injury
  • Concomitant injuries affecting ambulation
  • Presence of another injury or medical condition that prevents ambulation
  • Presence of implant or sacral morphology that prevents percutaneous sacral fixation
  • Enrollment in another research study the precludes co-enrollment
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)
  • Incarcerated or pending incarceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-operative
Pain management and physical therapy advanced with weight bearing as tolerated.
Other: Pain management
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Other: Physical therapy
Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated
Experimental: Operative
Percutaneous screw fixation
Procedure: Percutaneous screw fixation
Surgical intervention in the form of percutaneous screw fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG) assessment
Time Frame: Day 2 after treatment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
Day 2 after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sacral Region Pain by Visual Analog Scale
Time Frame: Day 2, 2 weeks, 6 weeks, and 3 months after treatment
Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)
Day 2, 2 weeks, 6 weeks, and 3 months after treatment
Discharge Disposition Location
Time Frame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)
Post discharge from treatment, an average of 5 days from being admitted to the hospital
Longest Distance of Ambulation
Time Frame: Day 2 after treatment
How far a patient was able to walk
Day 2 after treatment
Use of Narcotic Pain Medication
Time Frame: Day 2 after treatment
Use of narcotic pain medication, total in milligram equivalents (MME)
Day 2 after treatment
Hospital Length of Stay
Time Frame: Post discharge from treatment, an average of 5 days from being admitted to the hospital
Number of days admitted to hospital during treatment
Post discharge from treatment, an average of 5 days from being admitted to the hospital
Rate of Complications
Time Frame: 2 weeks, 6 weeks, and 3 months after treatment
Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality
2 weeks, 6 weeks, and 3 months after treatment
Timed Up and Go (TUG) assessment
Time Frame: 2 weeks, 6 weeks, and 3 months after treatment
Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.
2 weeks, 6 weeks, and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Orthopaedic Trauma Association
Allina Health System

Investigators

  • Principal Investigator: Mai P. Nguyen, MD, University of Minnesota and HealthPartners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A22-184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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