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

Completed · Not applicable

Conditions studied: Sacroiliac Joint, Pain, Pelvis

In brief

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.

Key facts

Study ID

NCT02652611

Run by

University of Maryland, Baltimore

People needed

60

Starts

2015-09-01

Expected to finish

2020-12-01

Last updated by the study team

2024-10-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Maryland, Shock Trauma Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.