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Completed

NCT Number: NCT05765669

Geriatric Lateral Compression 1 Pelvic Fractures

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.

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allina, Mercy Hospital, Coon Rapids, Minnesota, United States

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About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous screw fixation

Procedure

Surgical intervention in the form of percutaneous screw fixation

Pain management

Other

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

Physical Therapy

Other

Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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)

  4. Longest Distance of Ambulation

    Time frame: Day 2 after treatment

    How far a patient was able to walk

  5. Use of Narcotic Pain Medication

    Time frame: Day 2 after treatment

    Use of narcotic pain medication, total in milligram equivalents (MME)

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Allina Health System
  • Orthopaedic Trauma Association

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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