Sacroiliac (SI) Screws: The Effect of SI Screw Removal on Patient-Reported Pain and Functional Outcomes
NCT ID: NCT02652611
Last Updated: 2024-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-09-30
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
SI Screw Removal Surgery
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.
Non-screw removal treatment (non-operative management)
Interventions
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SI Screw Removal Surgery
Non-screw removal treatment (non-operative management)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Marcus Sciadini
Associate Professor in Orthopaedics
Principal Investigators
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Marcus Sciadini, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Gerard Slobogean, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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University of Maryland, Shock Trauma Center
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HP-00063838
Identifier Type: -
Identifier Source: org_study_id
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