Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes

The Effect of Sacroiliac (SI) Screw Removal on Patient-Reported Pain and Functional Outcomes After Open or Closed Reduction and Internal Fixation of Pelvic Fractures

Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patient's quality of life. Persistent pain after radiographic evidence of fracture union commonly leads to implant removal. But, the routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate.

Many surgeons remember patients whose intractable, hardly explainable local symptoms and complaints of pain resolved quickly after a hardware-removal procedure. However, implant removal requires a second surgical procedure in scarred tissue, poses a risk for nerve damage, infection and re-fractures, and is not a guarantee of pain relief.

Rates of implant removal vary based on anatomic location and implant selection. Many studies have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur. But, there is currently no controlled trial that assesses the benefits and harms of sacroiliac (SI) screw removal in pelvic fracture patients.

Reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. There is conflicting evidence that removing hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to explore the effect of SI screw removal in pelvic fracture patients. The investigators propose to prospectively randomize patients with a pelvic fracture requiring the use of SI screws for stabilization to removal versus non-removal of SI screws and track which group has less pain and need for narcotic pain medications.

Inclusion Criteria:

• The patient is between 18 and 80 years of age, inclusive
• The patient has a pelvic fracture that required SI screw stabilization
• The patient has reached skeletal maturity
• The patient's pelvic fracture was the result of trauma (includes polytraumatized patients)
• The patient is English-speaking
• The patient's pelvic fracture was initially treated at Shock Trauma
• The patient is currently experiencing pain associated with his/her pelvic fracture
• The patient's surgeon agrees to randomization (the patient is amendable to either SI screw removal or non-screw removal treatment)
• The patient is able to be randomized between 4 and 8 months post-SI screw stabilization surgery at an orthopaedic follow-up appointment

Exclusion Criteria:

• 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 study that does not allow co-enrollment
• The patient is likely to have severe problems with maintaining follow-up