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

LC Pelvic Fracture Clinical Trial

Official title:

Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625766
• Other study ID #: HP-00060038
• Status: Completed
• Phase: N/A
• Start date: April 20, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2020
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• LC Pelvic Fracture

Intervention

Procedure:
• LC fracture surgical fixation

• LC fracture non-operative management

Locations

Country	Name	City	State
United States	University of Maryland, Shock Trauma Center	Baltimore	Maryland
United States	Indiana University Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Indiana University Health

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 12 weeks post injury
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.	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.	through patient discharge, up to 12 weeks post injury
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.	through patient discharge, up to 12 weeks post injury