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

University of Maryland, Baltimore95 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

LC Pelvic Fracture

Interventions

LC fracture surgical fixationPROCEDURE

LC fracture non-operative managementPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Indiana University Health

Indianapolis, Indiana, United States

University of Maryland, Shock Trauma Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Posttreatment Pain

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.

Time frame: up to 12 weeks post injury

Secondary Outcomes

Posttreatment Function

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.

Time frame: up to 12 weeks post injury

Length of Hospitalization

Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.

Time frame: through patient discharge, up to 12 weeks post injury

Time to First Mobilization 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.

Time frame: through patient discharge, up to 12 weeks post injury

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.