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OpenTrials
Completed

NCT Number: NCT02625766

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

LC fracture surgical fixation

Procedure

LC fracture non-operative management

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Indiana University Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Dec 9, 2015
Registry last updated
May 9, 2022

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.