Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02652611
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2016-01-06
Brief Title:
Sacroiliac SI Screws The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIS
Brief Summary:
Chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patients 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None