Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures

• ClinicalTrials.gov Identifier: NCT02625766
• Recruitment Status: Active, not recruiting
• First Posted: December 9, 2015
• Last Update Posted: March 16, 2020
• Sponsor: University of Maryland, Baltimore
• Collaborator: Indiana University Health
• Information provided by (Responsible Party): Robert O'Toole, University of Maryland, Baltimore

Tracking Information

• First Submitted Date: November 19, 2015
• First Posted Date: December 9, 2015
• Last Update Posted Date: March 16, 2020
• Actual Study Start Date: April 20, 2015
• Actual Primary Completion Date: December 10, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: LC Pelvic Fracture

Intervention

• Procedure: LC fracture surgical fixation
• Procedure: LC fracture non-operative management

Study Arms

• 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 *

• 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.
• 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.
• Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78.
• 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.
• 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. Erratum in: J Orthop Trauma. 2020 Feb;34(2):e77.
• 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.
• 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. Review.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 7, 2015): 130
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Actual Primary Completion Date: December 10, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02625766
• Other Study ID Numbers: HP-00060038
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert O'Toole, University of Maryland, Baltimore
• Study Sponsor: University of Maryland, Baltimore
• Collaborators: Indiana University Health

Investigators

• Principal Investigator: Robert O'Toole, MD; University of Maryland, College Park

• PRS Account: University of Maryland, Baltimore
• Verification Date: March 2020