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| Name | Class |
|---|---|
| Indiana University Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Experimental | 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. |
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| Non-operative | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC fracture surgical fixation | Procedure |
| ||
| LC fracture non-operative management |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 12 weeks post injury |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert O'Toole, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health | Indianapolis | Indiana | 46202 | United States | ||
| University of Maryland, Shock Trauma Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3961516 | Background | Young JW, Burgess AR, Brumback RJ, Poka A. Lateral compression fractures of the pelvis: the importance of plain radiographs in the diagnosis and surgical management. Skeletal Radiol. 1986;15(2):103-9. doi: 10.1007/BF00350202. | |
| 20871246 | Background | Manson T, O'Toole RV, Whitney A, Duggan B, Sciadini M, Nascone J. Young-Burgess classification of pelvic ring fractures: does it predict mortality, transfusion requirements, and non-orthopaedic injuries? J Orthop Trauma. 2010 Oct;24(10):603-9. doi: 10.1097/BOT.0b013e3181d3cb6b. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | up to 12 weeks post injury |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hardware loosening | Surgical and medical procedures | Hardware loosening | Non-systematic Assessment | Reoperation due to hardware loosening |
The limitations of the trial are primarily related to its sample size and challenges with recruitment into a randomized controlled trial. The decision to enroll patients who refused randomization, but selected their treatment without surgeon's recommendation, was a study design decision carefully made to balance potential risks of bias with the benefits of increased study power from a larger sample size. Additionally, we acknowledge that we were unable to obtain preoperative pain scores.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Administrator | University of Maryland Medical Center | 4103289579 | NO'Hara@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2016 | Apr 20, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 28, 2020 | Apr 20, 2021 | SAP_001.pdf |
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| Procedure |
|
| 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. | 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. | through patient discharge, up to 12 weeks post injury |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| 16263614 | Background | Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. doi: 10.1080/17453670510041754. |
| 7623172 | Background | Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005. |
| 21857419 | Background | Bruce B, Reilly M, Sims S. OTA highlight paper predicting future displacement of nonoperatively managed lateral compression sacral fractures: can it be done? J Orthop Trauma. 2011 Sep;25(9):523-7. doi: 10.1097/BOT.0b013e3181f8be33. |
| 24740110 | Background | Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130. |
| 19184260 | Background | Kanakaris NK, Angoules AG, Nikolaou VS, Kontakis G, Giannoudis PV. Treatment and outcomes of pelvic malunions and nonunions: a systematic review. Clin Orthop Relat Res. 2009 Aug;467(8):2112-24. doi: 10.1007/s11999-009-0712-2. Epub 2009 Jan 30. |
| 19996807 | Background | Barei DP, Shafer BL, Beingessner DM, Gardner MJ, Nork SE, Routt ML. The impact of open reduction internal fixation on acute pain management in unstable pelvic ring injuries. J Trauma. 2010 Apr;68(4):949-53. doi: 10.1097/TA.0b013e3181af69be. |
| 23096135 | Background | Tosounidis T, Kanakaris N, Nikolaou V, Tan B, Giannoudis PV. Assessment of Lateral Compression type 1 pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable? Int Orthop. 2012 Dec;36(12):2553-8. doi: 10.1007/s00264-012-1685-4. Epub 2012 Oct 25. |
| 21857421 | Background | Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae. |
| 37653607 | Derived | McKibben NS, O'Hara NN, Slobogean GP, Gaski GE, Nascone JW, Sciadini MF, Natoli RM, McKinley T, Virkus WW, Sorkin AT, Howe A, O'Toole RV, Levy JF. Work Productivity Loss After Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2024 Jan 1;38(1):42-48. doi: 10.1097/BOT.0000000000002681. |
| 33993178 | Derived | Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| History of Comorbidities | Count of Participants | Participants |
|
| Mechanism of Injury | Count of Participants | Participants |
|
| Injury Severity Score (ISS) | ISS is an internationally recognized scoring system that assesses mortality, morbidity, and other measures of trauma severity. It is based on an anatomical injury severity classification, the Abbreviated Injury Scale (AIS) and is calculated as the sum of the squares of the highest AIS code in each of the three most severely injured ISS body regions. These body regions are: Head or neck, Face, Chest, Abdomen, Extremities (including pelvis), and External. ISS ranges from 1 to 75, 1 indicating very few injuries, and 75 indicating virtually unsurvivable injuries. | Mean | Standard Deviation | scores on a scale |
|
| Fracture Type | Lateral compression type 1 (LC1) are defined by an impaction fracture at the sacrum. LC type 2 (LC2) have a fracture that extends through the posterior iliac wing at the level of the sacroiliac joint. Both patterns will have varying amounts of anterior pubic root/rami fractures. | Count of Participants | Participants |
|
| Initial Fracture Displacement | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of score on a scale | up to 12 weeks post injury |
|
|
|
| Secondary | Length of Hospitalization | Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay. | Posted | Mean | Inter-Quartile Range | days | through patient discharge, up to 12 weeks post injury |
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|
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| 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. | Posted | Median | Inter-Quartile Range | days | through patient discharge, up to 12 weeks post injury |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 3 |
| 47 |
| EG001 | 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 | 0 | 48 | 0 | 48 | 4 | 48 |
|
| Wound seroma requiring drainage | Surgical and medical procedures | Wound seroma | Non-systematic Assessment | Wound seroma requiring drainage |
|
| Unplanned fixation | Surgical and medical procedures | Unplanned fixation | Non-systematic Assessment | Patient randomized to non-operative treatment who later required fixation. |
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| 12 wk |
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