Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | September 2015 |
| End Date: | December 2019 |
| Contact: | Marcus Sciadini, MD |
| Email: | msciadini@umoa.umm.edu |
| Phone: | 410-328-5435 |
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.
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.
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
We found this trial at
1
site
Baltimore, Maryland
Principal Investigator: Marcus Sciadini
Phone: 410-706-1604
Click here to add this to my saved trials
