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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Sacroiliac Joint, Pain, Pelvis

Intervention / Treatment
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* Procedure: SI Screw Removal Surgery
* Procedure: Non-screw removal treatment (non-operative management)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screw Removal<br>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<br> <br> |
| Experimental: Non-screw Removal<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Up to 24 months post initial SI screw stabilization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic use as measured by the patient's medical record during follow-up clinic appointments |  | Up to 24 months post initial SI screw stabilization | 
| Work productivity and impairment as measured by the WPAI:SHP questionnaire |  | Up to 24 months post initial SI screw stabilization | 
| Health related quality of life as measured by the SF-12 questionnaire |  | Up to 24 months post initial SI screw stabilization | 
| Pelvic specific function as measured by the Majeed Pelvic Score questionnaire |  | Up to 24 months post initial SI screw stabilization | 
| General function as measured by the SMFA questionnaire |  | Up to 24 months post initial SI screw stabilization | 
| Surgical-related complications as measured by the patient's medical record during follow-up clinic appointments |  | Up to 24 months post initial SI screw stabilization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screw Removal vs. Non-screw removal, Complications, SI Screw Stabilization