Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures

April 11, 2022 updated by: Robert O'Toole, University of Maryland, Baltimore

Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial

Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both operative and non-operative treatment can be successful.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The crux of the problem is determining which of these patients would benefit from early surgical stabilization and which will heal uneventfully without surgery. Many authors site patient pain and inability to mobilize as indications for surgery, although there is conflicting evidence supporting this claim. The presence of chronic pain in the trauma population is a growing area of interest, and there is a push towards controlling pain more effectively in the acute setting. It remains to be proven that surgical intervention is more effective at decreasing acute and longer term pain.

There is evidence in the literature to support both operative and non-operative treatment of patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical stabilization decreases acute pain and narcotic requirements, although patients are often counseled to that effect. The investigators propose to prospectively randomize patients with lateral compression type pelvic fractures to non-operative versus operative treatment and track which group has less pain, less need for narcotic pain medications, and who mobilizes with physical therapy faster.

Study Type

Interventional

Enrollment (Actual)

95

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 Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Shock Trauma Center

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
  • The patient is between 18 and 80 years of age, inclusive
  • The patient has reached skeletal maturity
  • The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
  • The patient/family/guardian is English-speaking
  • The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
  • Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury

Exclusion Criteria:

  • The patient has prior surgical hardware in place that precludes intervention
  • The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
  • The patient received prior surgical intervention for his/her current pelvic injury
  • The patient has sacral morphology that precludes percutaneous fixation
  • The patient is non-ambulatory due to an associated spinal cord injury
  • The patient was non-ambulatory pre-injury
  • The patient is currently pregnant
  • The patient is enrolled in another research study that does not allow co-enrollment
  • The patient is likely to have severe problems with maintaining follow-up

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Operative
Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.
Procedure: LC fracture surgical fixation
EXPERIMENTAL: Non-operative
Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.
Procedure: LC fracture non-operative management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttreatment Pain
Time Frame: up to 12 weeks post injury
The primary outcome was patient-reported pain severity, as measured by the mean of the 4 pain severity items of the Brief Pain Inventory (BPI): worst pain in the last 24 hours, least pain in the last 24 hours, pain on average, and pain right now. The BPI uses a 0-10 level visual analog scale (VAS) with a 24-hour recall period, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The minimum clinically important difference (MCID) is not definitively established for the BPI in a trauma population; however, the MCID for other 10-point VAS pain scales has been reported between 1.0-2.5 points.
up to 12 weeks post injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttreatment Function
Time Frame: up to 12 weeks post injury
Secondary functional outcome was measured by the Majeed pelvic score. The Majeed pelvic score is a seven-item patient-reported outcome instrument that measures pain, work status, sitting comfort, sexual intercourse, use of walking aids, gait disturbance, and walking distance. The score is reported as a percentage of the highest possible score to adjust for participants who were not employed before their injury. Higher scores represent better function, and a score of >85% has been suggested to represent excellent function.
up to 12 weeks post injury
Length of Hospitalization
Time Frame: through patient discharge, up to 12 weeks post injury
Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.
through patient discharge, up to 12 weeks post injury
Time to First Mobilization Post Injury
Time Frame: through patient discharge, up to 12 weeks post injury
Time to first mobilization (bed to chair) is determined using the physical therapy notes during the patient's index hospitalization and is recorded as the number of days post injury that mobilization first occurred.
through patient discharge, up to 12 weeks post injury

Collaborators and Investigators

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

Sponsor

University of Maryland, Baltimore

Collaborators

Indiana University Health

Investigators

  • Principal Investigator: Robert O'Toole, MD, University of Maryland

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

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)

April 20, 2015

Primary Completion (ACTUAL)

December 10, 2018

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (ESTIMATE)

December 9, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00060038

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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