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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 : Recruiting
First Posted : December 9, 2015
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Indiana University Health
Information provided by (Responsible Party):
Robert O'Toole, University of Maryland

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.

Condition or disease Intervention/treatment Phase
LC Pelvic Fracture Procedure: LC fracture surgical fixation Procedure: LC fracture non-operative management Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Procedure: LC fracture non-operative management



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Work productivity and impairment will be determined using the WPAI:SHP questionnaire [ Time Frame: Up to 1 year post injury ]
  5. Health related quality of life will be measured using the SF-12 questionnaire [ Time Frame: Up to 1 year post injury ]
  6. Pelvic function will be measured using the Majeed Pelvic Score [ Time Frame: Up to 1 year post injury ]
  7. General function will be measured using the SMFA questionnaire [ Time Frame: Up to 1 year post injury ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Robert O'Toole, MD 410-328-6040 rotoole@umoa.umm.edu
Contact: Andrea Howe 410-706-6823 ahowe@umoa.umm.edu

Locations
United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Krista Brown    317-963-1944    brownkm@indiana.edu   
Principal Investigator: Greg Gaski, MD         
United States, Maryland
University of Maryland, Shock Trauma Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Andrea Howe    410-706-6823    ahowe@umoa.umm.edu   
Principal Investigator: Robert O'Toole, MD         
Sub-Investigator: Gerard Slobogean, MD         
Sponsors and Collaborators
University of Maryland
Indiana University Health
Investigators
Principal Investigator: Robert O'Toole, MD University of Maryland

Publications:

Responsible Party: Robert O'Toole, Head of the UM SOM's Division of Orthpaedic Traumatology and Chief of Orthopaedics for the University of Maryland Medical Center's (UMMC) R Adams Cowley Shock Trauma Center, University of Maryland
ClinicalTrials.gov Identifier: NCT02625766     History of Changes
Other Study ID Numbers: HP-00060038
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Robert O'Toole, University of Maryland:
Operative vs. Non-operative
LC pelvic fracture
Complications

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries