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

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ClinicalTrials.gov Identifier: NCT02652611
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Marcus Sciadini, University of Maryland, Baltimore

Brief 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.

Condition or disease Intervention/treatment Phase
Sacroiliac Joint Pain Pelvis Procedure: SI Screw Removal Surgery Procedure: Non-screw removal treatment (non-operative management) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Screw Removal
Patients enrolled in the SI screw removal treatment group will undergo the surgery 5-9 months after the initial SI screw stabilization surgery. The surgeon will remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.
Procedure: SI Screw Removal Surgery
Experimental: Non-screw Removal
Patients enrolled in the Non-SI screw removal treatment group will not undergo surgical intervention to for removal of their SI screws. remove all screws that he/she is able and feels is appropriate for the patient. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments as per standard of care to determine if the injury continues healing properly. If complications arise and/or the patient requires screw removal surgery, crossover will be allowed and recorded within study follow0up forms.
Procedure: Non-screw removal treatment (non-operative management)



Primary Outcome Measures :
  1. Pain as measured by using the arithmetic mean of the four pain visual analog scale severity items on the patient-reported Brief Pain Inventory (BPI) assessment [ Time Frame: Up to 24 months post initial SI screw stabilization ]

Secondary Outcome Measures :
  1. Narcotic use as measured by the patient's medical record during follow-up clinic appointments [ Time Frame: Up to 24 months post initial SI screw stabilization ]
  2. Work productivity and impairment as measured by the WPAI:SHP questionnaire [ Time Frame: Up to 24 months post initial SI screw stabilization ]
  3. Health related quality of life as measured by the SF-12 questionnaire [ Time Frame: Up to 24 months post initial SI screw stabilization ]
  4. Pelvic specific function as measured by the Majeed Pelvic Score questionnaire [ Time Frame: Up to 24 months post initial SI screw stabilization ]
  5. General function as measured by the SMFA questionnaire [ Time Frame: Up to 24 months post initial SI screw stabilization ]
  6. Surgical-related complications as measured by the patient's medical record during follow-up clinic appointments [ Time Frame: Up to 24 months post initial SI screw stabilization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652611


Locations
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United States, Maryland
University of Maryland, Shock Trauma Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Marcus Sciadini, MD University of Maryland, College Park
Principal Investigator: Gerard Slobogean, MD University of Maryland, College Park

Publications:

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Responsible Party: Marcus Sciadini, Associate Professor in Orthopaedics, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02652611    
Other Study ID Numbers: HP-00063838
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marcus Sciadini, University of Maryland, Baltimore:
Screw Removal vs. Non-screw removal
Complications
SI Screw Stabilization