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Principle Investigator left the institution
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The purpose of this study is to compare subcutaneous internal fixation and open plating of the symphysis in patients with a disruption of the symphysis requiring stabilization.
The aim of this study is to determine whether either one of the two procedures has significant advantages over the other. The null hypothesis of this study is that there is no difference between plating and subcutaneous internal fixation of symphysis disruptions with respect to primary and secondary outcomes. The study is a randomized trial with patients who sustained a symphysis disruption who will randomize to either closed reduction and subcutaneous internal fixation, or open reduction and plating of the symphysis. There will also be two observational arms of the study, patients who do not agree to randomization and will receive internal fixation according to the treating surgeon's discretion and patients with a symphysis disruption that do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. Clinical assessments will occur at the time of hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months, 6months, 12 months, and 24 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to Internal Fixator | Experimental | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention would be internal fixator. |
|
| Randomized to Symphyseal Plate | Experimental | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention would be internal plating of the symphysis. |
|
| Observational - Internal Fixator | Active Comparator | Patient signed consent but did not want to randomize their procedure and the treating physician selected the internal fixator intervention based on their opinion of how best to treat the specific case. |
|
| Observational - Symphyseal Plate | Active Comparator | Patient signed consent but did not want to randomize their procedure and the treating physician selected internal plating of the symphysis based on their opinion of how best to treat the specific case. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal Fixator | Procedure | Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcomes | The primary objective is to compare functional outcomes between subcutaneous internal fixation and symphyseal plating as measured by the PROMIS v1.2-Physical Function instrument. | 24 hours - 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the health-related quality of life and functional outcome scores | We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS v1.1 - Pain Interference, PROMIS v1.2 - Mobility, PROMIS v1.0 - Global Satisfaction with Sex Life, PROMIS v1.0 - Depression, Majeed score, SF-12, VAS, patient satisfaction score, time to return to work, revision surgery, use of assistive walking devices, length of hospital stay, and for me, PROMIS v1.0 - Erectile Function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Zlowodzki, MD | Indiana University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2746708 | Background | Dalal SA, Burgess AR, Siegel JH, Young JW, Brumback RJ, Poka A, Dunham CM, Gens D, Bathon H. Pelvic fracture in multiple trauma: classification by mechanism is key to pattern of organ injury, resuscitative requirements, and outcome. J Trauma. 1989 Jul;29(7):981-1000; discussion 1000-2. | |
| 22337480 | Background |
| Label | URL |
|---|---|
| PROMIS outcome questionnaires | View source |
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| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
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| Symphyseal Plate | Procedure | A plate that spans across the symphysis to maintain reduction and stability. |
|
| 24 hours - 24 months |
| Vallier HA, Cureton BA, Schubeck D, Wang XF. Functional outcomes in women after high-energy pelvic ring injury. J Orthop Trauma. 2012 May;26(5):296-301. doi: 10.1097/BOT.0b013e318221e94e. |
| 15949483 | Background | Raman R, Roberts CS, Pape HC, Giannoudis PV. Implant retention and removal after internal fixation of the symphysis pubis. Injury. 2005 Jul;36(7):827-31. doi: 10.1016/j.injury.2004.11.012. Epub 2005 Feb 25. |
| 22011632 | Background | Vallier HA, Cureton BA, Schubeck D. Pelvic ring injury is associated with sexual dysfunction in women. J Orthop Trauma. 2012 May;26(5):308-13. doi: 10.1097/BOT.0b013e31821d700e. |
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| 22383020 | Background | Merriman DJ, Ricci WM, McAndrew CM, Gardner MJ. Is application of an internal anterior pelvic fixator anatomically feasible? Clin Orthop Relat Res. 2012 Aug;470(8):2111-5. doi: 10.1007/s11999-012-2287-6. |
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| 22219004 | Background | Vaidya R, Kubiak EN, Bergin PF, Dombroski DG, Critchlow RJ, Sethi A, Starr AJ. Complications of anterior subcutaneous internal fixation for unstable pelvis fractures: a multicenter study. Clin Orthop Relat Res. 2012 Aug;470(8):2124-31. doi: 10.1007/s11999-011-2233-z. |
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| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |