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Principle Investigator left institution
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The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion.
The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. This type of injury requires follow up at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. At each follow up appointment, the patient will be asked to complete surveys as part of the PROMIS series (Patient Reported Outcomes Measurement Information System) which will include surveys about physical function, pain, mobility, sex life satisfaction, depression, and for male patients, a survey about erectile function. In addition to the PROMIS questionnaire for pain, the investigators will also use a visual analogue pain scale and ask what the patient's satisfaction is on a scale of 0-100%. If the patient does not report to clinic for follow up, the research coordinator will call the patient to complete the study questionnaires.
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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 will be internal fixator. |
|
| Randomized to External Fixator | Experimental | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. |
|
| Observational - Internal Fixator | Other | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator. |
|
| Observational - External Fixator | Other | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator. |
|
| 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 (PROMIS v1.2-Physical Function Instrument) | The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument. | 24 hrs - 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Breakage or Failure Rates | We will compare the implant failure/breakage rate between the two interventions. | 24 hours - 24 months |
| Infection Rates | We will compare the rate of infection between the two interventions. |
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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 |
|---|---|---|---|
| 11110141 | Background | Arazi M, Kutlu A, Mutlu M, Yel M, Kapiciglu MI. The pelvic external fixation: the mid-term results of 41 patients treated with a newly designed fixator. Arch Orthop Trauma Surg. 2000;120(10):584-6. doi: 10.1007/s004020000142. | |
| 16132252 | Background | Gansslen A, Pohlemann T, Krettek C. [A simple supraacetabular external fixation for pelvic ring fractures]. Oper Orthop Traumatol. 2005 Sep;17(3):296-312. doi: 10.1007/s00064-005-1134-2. German. |
| Label | URL |
|---|---|
| PROMIS outcome questionnaires | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized to Internal Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator. Internal Fixator: 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. |
| FG001 | Randomized to External Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
| FG002 | Observational - Internal Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator. Internal Fixator: 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. |
| FG003 | Observational - External Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to Internal Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator. Internal Fixator: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Functional Outcomes (PROMIS v1.2-Physical Function Instrument) | The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument. | No data was analyzed for this study. The PI left our institution and the study was pre-maturely closed. With such a small patient population, the data that was collected was not analyzed because achieving statistical significance was not possible. | Posted | 24 hrs - 24 months |
|
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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 | Randomized to Internal Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator. Internal Fixator: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Krista Brown, Clinical Research Coordinator | Indiana University | 317-963-1944 | brownkm@indiana.edu |
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| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
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| External fixator | Procedure | External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
|
| 24 hours - 24 months |
| Revision Surgery Rates | We will compare the revision surgery rates between the two interventions. | 24 hours - 24 months |
| Health-related Qualify of Life | We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function. | 24 hours - 24 months |
| Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries) | We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome | 24 hours - 24 months |
| Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function) | We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function. | 24 hours - 24 months |
| 9680022 | Background | Hupel TM, McKee MD, Waddell JP, Schemitsch EH. Primary external fixation of rotationally unstable pelvic fractures in obese patients. J Trauma. 1998 Jul;45(1):111-5. doi: 10.1097/00005373-199807000-00024. |
| 10615965 | Background | Lindahl J, Hirvensalo E, Bostman O, Santavirta S. Failure of reduction with an external fixator in the management of injuries of the pelvic ring. Long-term evaluation of 110 patients. J Bone Joint Surg Br. 1999 Nov;81(6):955-62. doi: 10.1302/0301-620x.81b6.8571. |
| 2380212 | Background | Majeed SA. External fixation of the injured pelvis. The functional outcome. J Bone Joint Surg Br. 1990 Jul;72(4):612-4. doi: 10.1302/0301-620X.72B4.2380212. |
| 7418325 | Background | Mears DC, Fu FH. Modern concepts of external skeletal fixation of the pelvis. Clin Orthop Relat Res. 1980 Sep;(151):65-72. |
| 11130512 | Background | Tucker MC, Nork SE, Simonian PT, Routt ML Jr. Simple anterior pelvic external fixation. J Trauma. 2000 Dec;49(6):989-94. doi: 10.1097/00005373-200012000-00002. |
| 2925751 | Background | Majeed SA. Grading the outcome of pelvic fractures. J Bone Joint Surg Br. 1989 Mar;71(2):304-6. doi: 10.1302/0301-620X.71B2.2925751. |
| 8230327 | Background | Riemer BL, Butterfield SL, Diamond DL, Young JC, Raves JJ, Cottington E, Kislan K. Acute mortality associated with injuries to the pelvic ring: the role of early patient mobilization and external fixation. J Trauma. 1993 Nov;35(5):671-5; discussion 676-7. doi: 10.1097/00005373-199311000-00003. |
| 7118964 | Background | Wild JJ Jr, Hanson GW, Tullos HS. Unstable fractures of the pelvis treated by external fixation. J Bone Joint Surg Am. 1982 Sep;64(7):1010-20. |
| 22357081 | Background | Cole PA, Gauger EM, Anavian J, Ly TV, Morgan RA, Heddings AA. Anterior pelvic external fixator versus subcutaneous internal fixator in the treatment of anterior ring pelvic fractures. J Orthop Trauma. 2012 May;26(5):269-77. doi: 10.1097/BOT.0b013e3182410577. |
| 22048189 | Background | Gardner MJ, Mehta S, Mirza A, Ricci WM. Anterior pelvic reduction and fixation using a subcutaneous internal fixator. J Orthop Trauma. 2012 May;26(5):314-21. doi: 10.1097/BOT.0b013e318220bb22. |
| 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. |
| 22337488 | Background | Moazzam C, Heddings AA, Moodie P, Cole PA. Anterior pelvic subcutaneous internal fixator application: an anatomic study. J Orthop Trauma. 2012 May;26(5):263-8. doi: 10.1097/BOT.0b013e31823e6b82. |
| 22048183 | Background | Vaidya R, Colen R, Vigdorchik J, Tonnos F, Sethi A. Treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series. J Orthop Trauma. 2012 Jan;26(1):1-8. doi: 10.1097/BOT.0b013e318233b8a7. |
| 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. |
| 11491193 | Background | Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med. 2001 Jul;33(5):344-9. doi: 10.3109/07853890109002088. |
| 8628042 | Background | Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. |
| 14318624 | Background | PELTIER LF. COMPLICATIONS ASSOCIATED WITH FRACTURES OF THE PELVIS. J Bone Joint Surg Am. 1965 Jul;47:1060-9. No abstract available. |
| 21086087 | Background | Scaglione M, Parchi P, Digrandi G, Latessa M, Guido G. External fixation in pelvic fractures. Musculoskelet Surg. 2010 Nov;94(2):63-70. doi: 10.1007/s12306-010-0084-5. Epub 2010 Nov 18. |
| 8050249 | Background | Pohlemann T, Bosch U, Gansslen A, Tscherne H. The Hannover experience in management of pelvic fractures. Clin Orthop Relat Res. 1994 Aug;(305):69-80. |
| 23408176 | Background | Holstein JH, Pizanis A, Kohler D, Pohlemann T; Working Group Quality of Life After Pelvic Fractures. What are predictors for patients' quality of life after pelvic ring fractures? Clin Orthop Relat Res. 2013 Sep;471(9):2841-5. doi: 10.1007/s11999-013-2840-y. |
| 14504576 | Background | Kabak S, Halici M, Tuncel M, Avsarogullari L, Baktir A, Basturk M. Functional outcome of open reduction and internal fixation for completely unstable pelvic ring fractures (type C): a report of 40 cases. J Orthop Trauma. 2003 Sep;17(8):555-62. doi: 10.1097/00005131-200309000-00003. |
| 7473997 | Background | McCarthy ML, MacKenzie EJ, Bosse MJ, Copeland CE, Hash CS, Burgess AR. Functional status following orthopedic trauma in young women. J Trauma. 1995 Nov;39(5):828-36; discussion 836-7. doi: 10.1097/00005373-199511000-00005. |
| 18448980 | Background | Mullis BH, Sagi HC. Minimum 1-year follow-up for patients with vertical shear sacroiliac joint dislocations treated with iliosacral screws: does joint ankylosis or anatomic reduction contribute to functional outcome? J Orthop Trauma. 2008 May-Jun;22(5):293-8. doi: 10.1097/BOT.0b013e31816b6b4e. |
| 9039360 | Background | Oliver CW, Twaddle B, Agel J, Routt ML Jr. Outcome after pelvic ring fractures: evaluation using the medical outcomes short form SF-36. Injury. 1996 Nov;27(9):635-41. doi: 10.1016/s0020-1383(96)00100-3. |
| 18090021 | Background | Suzuki T, Shindo M, Soma K, Minehara H, Nakamura K, Uchino M, Itoman M. Long-term functional outcome after unstable pelvic ring fracture. J Trauma. 2007 Oct;63(4):884-8. doi: 10.1097/01.ta.0000235888.90489.fc. |
| 22337480 | Background | 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. |
| 22434474 | Background | Lefaivre KA, Slobogean GP, Valeriote J, O'Brien PJ, Macadam SA. Reporting and interpretation of the functional outcomes after the surgical treatment of disruptions of the pelvic ring: a systematic review. J Bone Joint Surg Br. 2012 Apr;94(4):549-55. doi: 10.1302/0301-620X.94B4.27960. |
| 23571293 | Background | Lefaivre KA, Slobogean GP, Ngai JT, Broekhuyse HM, O'Brien PJ. What outcomes are important for patients after pelvic trauma? Subjective responses and psychometric analysis of three published pelvic-specific outcome instruments. J Orthop Trauma. 2014 Jan;28(1):23-7. doi: 10.1097/BOT.0b013e3182945fe9. |
| 14662277 | Background | Sprague S, Leece P, Bhandari M, Tornetta P 3rd, Schemitsch E, Swiontkowski MF; S.P.R.I.N.T. Investigators. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003 Dec;24(6):719-25. doi: 10.1016/j.cct.2003.08.012. |
| BG001 | Randomized to External Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
| BG002 | Observational - Internal Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator. Internal Fixator: 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. |
| BG003 | Observational - External Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Randomized to External Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
| OG002 | Observational - Internal Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator. Internal Fixator: 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. |
| OG003 | Observational - External Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. |
|
| Secondary | Implant Breakage or Failure Rates | We will compare the implant failure/breakage rate between the two interventions. | No analyses were done on this study. We did not enroll enough patients in order to come to any conclusions prior to the PI leaving the institution. | Posted | 24 hours - 24 months |
|
|
| Secondary | Infection Rates | We will compare the rate of infection between the two interventions. | Not Posted | 24 hours - 24 months | Participants |
| Secondary | Revision Surgery Rates | We will compare the revision surgery rates between the two interventions. | Not Posted | 24 hours - 24 months | Participants |
| Secondary | Health-related Qualify of Life | We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function. | Not Posted | 24 hours - 24 months | Participants |
| Secondary | Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries) | We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome | Not Posted | 24 hours - 24 months | Participants |
| Secondary | Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function) | We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function. | Not Posted | 24 hours - 24 months | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Randomized to External Fixator | Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. | 0 | 0 | 0 | 0 |
| EG002 | Observational - Internal Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator. Internal Fixator: 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. | 0 | 1 | 0 | 1 |
| EG003 | Observational - External Fixator | Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator. External fixator: External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body. | 0 | 1 | 0 | 1 |
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| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|