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N/A N=60 Randomized Treatment

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

Sacroiliac Joint · Pain · Pelvis

Bottom Line

View on ClinicalTrials.gov: NCT02652611 ↗
Enrolled (actual)
60
Serious AEs
7.1%
Results posted
Oct 2024
Primary outcome: Primary: Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI) — 3.7; 4.7 units on a scale — p==0.57

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SI Screw Removal Surgery (Procedure); Non-screw removal treatment (non-operative management) (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Maryland, Baltimore
Primary completion
Oct 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)		 3.7; 4.7 =0.57
SECONDARY
Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.		 68.3; 63.6 0.21

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02652611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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