LC Pelvic Fracture
Conditions
Keywords
Operative vs. Non-operative, LC pelvic fracture, Complications
Brief summary
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.
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.
Interventions
PROCEDURELC fracture surgical fixation
PROCEDURELC fracture non-operative management
Sponsors
Indiana University Health
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttreatment Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Posttreatment Function | 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. |
| Length of Hospitalization | 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. |
| Time to First Mobilization Post Injury | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
LC fracture surgical fixation | 47 |
| 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.
LC fracture non-operative management | 48 |
| Total | 95 |
Baseline characteristics
| Characteristic | Non-operative | Total | Operative |
|---|---|---|---|
| Age, Continuous | 43.5 years STANDARD_DEVIATION 17.9 | 43.5 years STANDARD_DEVIATION 18.3 | 43.6 years STANDARD_DEVIATION 18.9 |
| BMI Normal (18.5-24.9 kg/m^2) | 29 Participants | 52 Participants | 23 Participants |
| BMI Obese (>30 kg/m^2) | 8 Participants | 15 Participants | 7 Participants |
| BMI Overweight (25-29.9 kg/m^2) | 11 Participants | 26 Participants | 15 Participants |
| BMI Underweight (< 18.5 kg/m^2) | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 94 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fracture Type Lateral Compression Type 1 | 36 Participants | 67 Participants | 31 Participants |
| Fracture Type Lateral Compression Type 2 | 12 Participants | 28 Participants | 16 Participants |
| History of Comorbidities Comorbidities | 36 Participants | 74 Participants | 38 Participants |
| History of Comorbidities No Comorbidities | 12 Participants | 21 Participants | 9 Participants |
| Initial Fracture Displacement 5-10 mm (displaced) | 15 Participants | 26 Participants | 11 Participants |
| Initial Fracture Displacement <5 mm (no/minimal displacement) | 33 Participants | 69 Participants | 36 Participants |
| Injury Severity Score (ISS) | 18 scores on a scale STANDARD_DEVIATION 10 | 17 scores on a scale STANDARD_DEVIATION 9 | 17 scores on a scale STANDARD_DEVIATION 9 |
| Mechanism of Injury Fall | 9 Participants | 19 Participants | 10 Participants |
| Mechanism of Injury Motor Vehicle | 38 Participants | 74 Participants | 36 Participants |
| Mechanism of Injury Other | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 77 Participants | 38 Participants |
| Sex: Female, Male Female | 32 Participants | 60 Participants | 28 Participants |
| Sex: Female, Male Male | 16 Participants | 35 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 |
| other Total, other adverse events | 3 / 47 | 4 / 48 |
| serious Total, serious adverse events | 0 / 47 | 0 / 48 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Operative | Posttreatment Pain | 96 hr | 5.3 scores on a scale | Standard Deviation 1.8 |
| Operative | Posttreatment Pain | 2 wk | 4.2 scores on a scale | Standard Deviation 2 |
| Operative | Posttreatment Pain | 6 wk | 2.7 scores on a scale | Standard Deviation 2.6 |
| Operative | Posttreatment Pain | 12 wk | 1.9 scores on a scale | Standard Deviation 2 |
| Non-operative | Posttreatment Pain | 12 wk | 2.9 scores on a scale | Standard Deviation 2.7 |
| Non-operative | Posttreatment Pain | 96 hr | 6.2 scores on a scale | Standard Deviation 2.4 |
| Non-operative | Posttreatment Pain | 6 wk | 3.5 scores on a scale | Standard Deviation 3.1 |
| Non-operative | Posttreatment Pain | 2 wk | 5.6 scores on a scale | Standard Deviation 2.3 |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Operative | Length of Hospitalization | 6.9 days |
| Non-operative | Length of Hospitalization | 6.6 days |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Operative | Posttreatment Function | 2 wk | 38 percentage of score on a scale | Standard Deviation 11 |
| Operative | Posttreatment Function | 6 wk | 55 percentage of score on a scale | Standard Deviation 18 |
| Operative | Posttreatment Function | 12 wk | 73 percentage of score on a scale | Standard Deviation 20 |
| Non-operative | Posttreatment Function | 2 wk | 31 percentage of score on a scale | Standard Deviation 10 |
| Non-operative | Posttreatment Function | 6 wk | 50 percentage of score on a scale | Standard Deviation 18 |
| Non-operative | Posttreatment Function | 12 wk | 62 percentage of score on a scale | Standard Deviation 22 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Operative | Time to First Mobilization Post Injury | 3 days |
| Non-operative | Time to First Mobilization Post Injury | 3 days |