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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
Sponsor:
Collaborator:
Indiana University Health
Information provided by (Responsible Party):
Robert O'Toole, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE December 9, 2015
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE April 20, 2015
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Official Title  ICMJE Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE LC Pelvic Fracture
Intervention  ICMJE
  • Procedure: LC fracture surgical fixation
  • Procedure: LC fracture non-operative management
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Procedure: LC fracture surgical fixation
  • Experimental: 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.
    Intervention: Procedure: LC fracture non-operative management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02625766
Other Study ID Numbers  ICMJE HP-00060038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert O'Toole, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Indiana University Health
Investigators  ICMJE
Principal Investigator: Robert O'Toole, MD University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP