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Completed

NCT Number: NCT02652611

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

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.

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Key information

Conditions

Sacroiliac Joint Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvis Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland, Shock Trauma Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SI Screw Removal Surgery

Procedure

Non-screw removal treatment (non-operative management)

Procedure

Primary outcomes

  1. Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)

    Time frame: Up to 24 months post initial SI screw stabilization

    The BPI is presented on a 0-10 level visual analog scale with a 24-hour recall period. A level of 0 is described to the patients as "no pain," and "10" described as "pain as bad as you can imagine." The BPI includes four items: the worst pain the patient has felt in the last 24 hours, the least pain the patient has felt in the last 24 hours, the average pain the patient has felt in the last 24 hours, and the pain the patient feels right now. The BPI score is the average of the four items.

Secondary outcomes

  1. Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.

    Time frame: Up to 24 months post initial SI screw stabilization

    The Majeed Pelvic Outcome Score is a clinically validated tool that assesses pain, working status, walking distance, sitting, sexual intercourse, walking aids, unaided gait, and walking distance. The score is reported on a 0-100 point scale with higher values indicating better pelvic function.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Acronym: SIS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2016
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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