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

Primary Purpose

LC Pelvic Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LC fracture surgical fixation
LC fracture non-operative management
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for LC Pelvic Fracture focused on measuring Operative vs. Non-operative, LC pelvic fracture, Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Health
  • University of Maryland, Shock Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Operative

Non-operative

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Length of Hospitalization
Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.
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.

Full Information

First Posted
November 19, 2015
Last Updated
April 11, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
Indiana University Health
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1. Study Identification

Unique Protocol Identification Number
NCT02625766
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2015 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Indiana University Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LC Pelvic Fracture
Keywords
Operative vs. Non-operative, LC pelvic fracture, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operative
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-operative
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
LC fracture surgical fixation
Intervention Type
Procedure
Intervention Name(s)
LC fracture non-operative management
Primary Outcome Measure Information:
Title
Posttreatment Pain
Description
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.
Time Frame
up to 12 weeks post injury
Secondary Outcome Measure Information:
Title
Posttreatment Function
Description
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.
Time Frame
up to 12 weeks post injury
Title
Length of Hospitalization
Description
Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.
Time Frame
through patient discharge, up to 12 weeks post injury
Title
Time to First Mobilization Post Injury
Description
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.
Time Frame
through patient discharge, up to 12 weeks post injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O'Toole, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland, Shock Trauma Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3961516
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. doi: 10.1007/BF00350202.
Results Reference
background
PubMed Identifier
20871246
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.
Results Reference
background
PubMed Identifier
16263614
Citation
Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. doi: 10.1080/17453670510041754.
Results Reference
background
PubMed Identifier
7623172
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. doi: 10.1097/00005131-199506000-00005.
Results Reference
background
PubMed Identifier
21857419
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.
Results Reference
background
PubMed Identifier
24740110
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.
Results Reference
background
PubMed Identifier
19184260
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.
Results Reference
background
PubMed Identifier
19996807
Citation
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.
Results Reference
background
PubMed Identifier
23096135
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.
Results Reference
background
PubMed Identifier
21857421
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.
Results Reference
background
PubMed Identifier
33993178
Citation
Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088.
Results Reference
derived

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

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