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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:5/4/2018
Start Date:December 2014
End Date:December 2020
Contact:Robert O'Toole, MD
Email:rotoole@umoa.umm.edu
Phone:410-328-6040

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Greg Gaski, MD
Phone: 317-963-1944
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Baltimore, Maryland
Principal Investigator: Robert O'Toole, MD
Phone: 410-706-6823
?
mi
from
Baltimore, MD
Click here to add this to my saved trials