Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
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|ClinicalTrials.gov Identifier: NCT02625766|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2015
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|LC Pelvic Fracture||Procedure: LC fracture surgical fixation Procedure: LC fracture non-operative management||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial|
|Actual Study Start Date :||April 20, 2015|
|Actual Primary Completion Date :||December 10, 2018|
|Estimated Study Completion Date :||December 2020|
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
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
- Pain as measured by using the arithmetic mean of the four pain visual analog scale severity items on the patient-reported Brief Pain Inventory assessment (BPI) [ Time Frame: Measured up to 1 year post injury ]
- Length of stay will be determined by recording the admission date versus discharge date for the patient's index hospitalization [ Time Frame: From the patient's initial admission date through patient's initial discharge date, assessed up to 6 months ]
- Time to first mobilization (bed to chair) will be determined using the physical therapy notes during the patient's index hospitalization [ Time Frame: From the patient's initial admission date through patient's initial discharge date, assessed up to 6 months ]
- Narcotic use will be determined by cross-referencing the patient's medical record during the index hospitalization and follow-up clinic appointments with patient-reported usage [ Time Frame: Up to 1 year post injury ]
- Work productivity and impairment will be determined using the WPAI:SHP questionnaire [ Time Frame: Up to 1 year post injury ]
- Health related quality of life will be measured using the SF-12 questionnaire [ Time Frame: Up to 1 year post injury ]
- Pelvic function will be measured using the Majeed Pelvic Score [ Time Frame: Up to 1 year post injury ]
- General function will be measured using the SMFA questionnaire [ Time Frame: Up to 1 year post injury ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625766
|United States, Indiana|
|Indiana University Health|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|University of Maryland, Shock Trauma Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Robert O'Toole, MD||University of Maryland, College Park|