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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Sacroiliac Joint; Pelvis
• Intervention / Treatment: Procedure: SI Screw Removal Surgery; Procedure: Non-screw removal treatment (non-operative management)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Shock Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Within 6 Months After Iliosacral Screw Removal Using the Brief Pain Inventory (BPI)	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.	Up to 24 months post initial SI screw stabilization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Function Within 6 Months After Iliosacral Screw Removal, Measured Using the Majeed Pelvic Outcome Score.	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.	Up to 24 months post initial SI screw stabilization

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Gerard Slobogean, MD, University of Maryland; Principal Investigator: Marcus Sciadini, MD, University of Maryland

Publications and helpful links

General Publications

• Brown OL, Dirschl DR, Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4. doi: 10.1097/00005131-200105000-00006.
• Jacobsen S, Honnens de Lichtenberg M, Jensen CM, Torholm C. Removal of internal fixation--the effect on patients' complaints: a study of 66 cases of removal of internal fixation after malleolar fractures. Foot Ankle Int. 1994 Apr;15(4):170-1. doi: 10.1177/107110079401500402.
• Dodenhoff RM, Dainton JN, Hutchins PM. Proximal thigh pain after femoral nailing. Causes and treatment. J Bone Joint Surg Br. 1997 Sep;79(5):738-41. doi: 10.1302/0301-620x.79b5.7345.
• Keating JF, Orfaly R, O'Brien PJ. Knee pain after tibial nailing. J Orthop Trauma. 1997 Jan;11(1):10-3. doi: 10.1097/00005131-199701000-00004.
• Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary tibial nailing: its incidence, etiology, and outcome. J Orthop Trauma. 1997 Feb-Mar;11(2):103-5. doi: 10.1097/00005131-199702000-00006.
• Busam ML, Esther RJ, Obremskey WT. Hardware removal: indications and expectations. J Am Acad Orthop Surg. 2006 Feb;14(2):113-20. doi: 10.5435/00124635-200602000-00006.
• Gerbershagen HJ, Dagtekin O, Isenberg J, Martens N, Ozgur E, Krep H, Sabatowski R, Petzke F. Chronic pain and disability after pelvic and acetabular fractures--assessment with the Mainz Pain Staging System. J Trauma. 2010 Jul;69(1):128-36. doi: 10.1097/TA.0b013e3181bbd703.
• Meyhoff CS, Thomsen CH, Rasmussen LS, Nielsen PR. High incidence of chronic pain following surgery for pelvic fracture. Clin J Pain. 2006 Feb;22(2):167-72. doi: 10.1097/01.ajp.0000174266.12831.a2.
• Pohlemann T, Tscherne H, Baumgartel F, Egbers HJ, Euler E, Maurer F, Fell M, Mayr E, Quirini WW, Schlickewei W, Weinberg A. [Pelvic fractures: epidemiology, therapy and long-term outcome. Overview of the multicenter study of the Pelvis Study Group]. Unfallchirurg. 1996 Mar;99(3):160-7. German.
• Hanson B, van der Werken C, Stengel D. Surgeons' beliefs and perceptions about removal of orthopaedic implants. BMC Musculoskelet Disord. 2008 May 24;9:73. doi: 10.1186/1471-2474-9-73.
• Toms AD, Morgan-Jones RL, Spencer-Jones R. Intramedullary femoral nailing: removing the nail improves subjective outcome. Injury. 2002 Apr;33(3):247-9. doi: 10.1016/s0020-1383(01)00145-0.
• Williams AA, Witten DM, Duester R, Chou LB. The benefits of implant removal from the foot and ankle. J Bone Joint Surg Am. 2012 Jul 18;94(14):1316-20. doi: 10.2106/JBJS.J.01756.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimated): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Complications; Screw Removal vs. Non-screw removal; SI Screw Stabilization
• Other Study ID Numbers: HP-00063838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO