Ignite Creation Date:
2024-05-06 @ 7:54 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02625766
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2015-11-19
Brief Title:
Pelvis RCT Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures a Prospective Trial
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None