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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screw Removal | Experimental | 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. |
|
| Non-screw Removal | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI Screw Removal Surgery | Procedure |
| ||
| Non-screw removal treatment (non-operative management) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Sciadini, MD | University of Maryland | Principal Investigator |
| Gerard Slobogean, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7951948 | Background | 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. | |
| 11371792 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. 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 follow up forms. Non-screw removal treatment (non-operative management) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Based on the limited enrollment in the trial and the high rate of treatment crossover in the trial, we pooled the randomized trial and observational patients for this analysis. To mitigate this bias, we matched patients who underwent iliosacral screw removal to a control group of patients who retained their iliosacral screws. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The study included patients aged 18-80 years with an unstable posterior pelvic ring fracture who underwent open or closed reduction and internal fixation with iliosacral screws. For inclusion, patients were screened for postoperative pain at a clinic visit between 4 and 8 months after their initial surgery. | Posted | Mean | Standard Deviation | units on a scale | Up to 24 months post initial SI screw stabilization |
|
24 months following surgery and enrollment into study
The definitions do not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations | Systematic Assessment | Patient readmitted 3 months post SI screw stabilization due to fever, elevated C reactive protein, and elevated erythrocyte sedimentation rate. Diagnosed with Bacteremia. Resolved non-operatively (4 weeks Ancef). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haley Demyanovich | U Maryland | 4107063935 | hdemyanovich@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2022 | Jan 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Procedure |
|
| Up to 24 months post initial SI screw stabilization |
| 9331026 | Background | 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. |
| 8990026 | Background | 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. |
| 9057144 | Background | 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. |
| 16467186 | Background | 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. |
| 20093984 | Background | 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. |
| 16428951 | Background | 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. |
| 8685720 | Background | 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. |
| 18501014 | Background | 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. |
| 12084641 | Background | 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. |
| 22810403 | Background | 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. |
| BG001 | 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. 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 follow-up forms. Non-screw removal treatment (non-operative management) |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| fracture classification | APC I injuries show less than 2.5 cm of symphyseal widening and have no posterior instability APC II injuries show widening of the symphysis pubis and instability of the posterior pelvis APC III injuries are those associated with complete posterior ligamentous disruption. LC I injuries result from a lateral force delivered over the posterior aspect of the pelvis LC II injuries result from a more anteriorly directed force. LC III injuries result from greater force. | Count of Participants | Participants |
|
| Area Deprivation Index | Socioeconomic status were measured using Area Deprivation Index (ADI). ADI is a mapping tool that displays the relative socioeconomic conditions of neighborhoods created from publicly-available data in the theoretical domains of income, education, employment and housing quality. ADIs are national percentile rankings from a low of 1 to a high of 100. A ranking of 1 indicates the lowest level of "disadvantage" within the nation and a ranking of 100 indicates the highest level of "disadvantage". | Mean | Standard Deviation | units on a scale |
|
| 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 |
| OG001 | 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. 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) |
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| Secondary | 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. | The study included patients aged 18-80 years with an unstable posterior pelvic ring fracture who underwent open or closed reduction and internal fixation with iliosacral screws. | Posted | Mean | Standard Deviation | score on a scale of 0-100 | Up to 24 months post initial SI screw stabilization |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. 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 follow-up forms. Non-screw removal treatment (non-operative management) | 1 | 14 | 1 | 14 | 0 | 14 |
|
| Unplanned surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient presents to outpatient clinic with foot-drop 12 months post SI screw stabilization (deficit present since trauma resulting in study injury). In attempt to correct deficit, surgeon conducted a lower extremity nerve decompression surgery. |
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