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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: LC Pelvic Fracture

Treatments: Procedure: LC fracture non-operative management; Procedure: LC fracture surgical fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02625766

HP-00060038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Operative

Experimental group

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.

Treatment:

Procedure: LC fracture surgical fixation

Non-operative

Experimental group

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.

Treatment:

Procedure: LC fracture non-operative management