N/A
N=95
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
LC Pelvic Fracture
Bottom Line
View on ClinicalTrials.gov: NCT02625766 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Posttreatment Pain — 5.3; 6.2; 4.2; 5.6 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LC fracture surgical fixation (Procedure); LC fracture non-operative management (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttreatment Pain |
5.3; 6.2; 4.2; 5.6; 2.7; 3.5 | — |
| SECONDARY Posttreatment Function |
38; 31; 55; 50; 73; 62 | — |
| SECONDARY Length of Hospitalization |
6.9; 6.6 | — |
| SECONDARY Time to First Mobilization Post Injury |
3; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02625766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.