Anterior Pelvic Ring Injury With Symphysis DisruptionNCT02399319
Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions
A study testing Internal Fixator and Symphyseal Plate in people with Anterior Pelvic Ring Injury With Symphysis Disruption, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Pelvic Ring Injury With Symphysis Disruption
- What is being tested?
- Internal Fixator and Symphyseal Plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 21 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs
- Need for anterior pelvic ring stabilization
- Injury amenable to plating as well as subcutaneous internal fixation per the treating surgeon's opinion
- Patient was ambulatory prior to sustaining the injury
- Provision of informed consent by patient or proxy
Who cannot join
- Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion
- Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address)
- Moderately or severely cognitively impaired patients
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions
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.
Read the detailed description
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).
- Being tested
- Internal Fixator, Symphyseal Plate
- Keywords
- anterior pelvic ring, symphysis disruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal FixatorProcedure or surgery
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.
Symphyseal PlateProcedure or surgery
A plate that spans across the symphysis to maintain reduction and stability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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. Receives: Procedure: Symphyseal Plate |
| 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. Receives: Procedure: Internal Fixator |
| 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. Receives: Procedure: Symphyseal Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours - 24 months
Secondary outcomes (1)
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.
Measured: 24 hours - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startOct 2014
- Primary completion21 Jul 2016
- Study completion21 Jul 2016
Why it stopped: Principle Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Anterior Pelvic Ring Injury With Symphysis DisruptionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zlowodzki, MD, Principal investigator, Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399319
- Sponsor's protocol ID
- 1403899155
- Status last verified
- Jul 2017
- First submitted
- 23 Mar 2015
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 2746708Vallier 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.
PubMed 22337480Raman 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.
PubMed 15949483Vallier 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.
PubMed 22011632Vallier HA, Cureton BA, Schubeck D. Pregnancy outcomes after pelvic ring injury. J Orthop Trauma. 2012 May;26(5):302-7. doi: 10.1097/BOT.0b013e31822428c5.
PubMed 22048182Cole 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.
PubMed 22357081Gardner 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.
PubMed 22048189Merriman 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.
PubMed 22383020Moazzam 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.
PubMed 22337488Vaidya 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.
PubMed 22219004Vaidya 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.
PubMed 22048183Majeed 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.
PubMed 2380212Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med. 2001 Jul;33(5):344-9. doi: 10.3109/07853890109002088.
PubMed 11491193Ware 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.
PubMed 8628042PELTIER LF. COMPLICATIONS ASSOCIATED WITH FRACTURES OF THE PELVIS. J Bone Joint Surg Am. 1965 Jul;47:1060-9. No abstract available.
PubMed 14318624
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions
- ClinicalTrials.gov ID
- NCT02399319
- Acronym / sponsor ID
- 1403899155
- Keywords
- anterior pelvic ring, symphysis disruption
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle Investigator left the institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 21 Jul 2016 (actual)
- Study completion
- 21 Jul 2016 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized to Internal Fixator | Experimental | Procedure: Internal FixatorPatient 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 | Procedure: Symphyseal PlatePatient 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 | Procedure: Internal FixatorPatient 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 | Procedure: Symphyseal PlatePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs
- Need for anterior pelvic ring stabilization
- Injury amenable to plating as well as subcutaneous internal fixation per the treating surgeon's opinion
- Patient was ambulatory prior to sustaining the injury
- Provision of informed consent by patient or proxy
Key exclusion criteria (5 listed)
- Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion
- Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address)
- Moderately or severely cognitively impaired patients
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal FixatorInternal 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. | Procedure or surgery | Observational - Internal Fixator, Randomized to Internal Fixator |
| Symphyseal PlateA plate that spans across the symphysis to maintain reduction and stability. | Procedure or surgery | Observational - Symphyseal Plate, Randomized to Symphyseal Plate |
Primary outcome
Functional Outcomes
Time frame: 24 hours - 24 months
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.
1 secondary outcome
Compare the health-related quality of life and functional outcome scores
Time frame: 24 hours - 24 months
Results and safety
The study was stopped early (reason given: Principle Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Background: PubMed 2746708Dalal 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.
- Background: PubMed 22337480Vallier 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.
- Background: PubMed 15949483Raman 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.
- Background: PubMed 22011632Vallier 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.
- Background: PubMed 22048182Vallier HA, Cureton BA, Schubeck D. Pregnancy outcomes after pelvic ring injury. J Orthop Trauma. 2012 May;26(5):302-7. doi: 10.1097/BOT.0b013e31822428c5.
- Background: PubMed 22357081Cole 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.
- Background: PubMed 22048189Gardner 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.
- Background: PubMed 22383020Merriman 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.
- Background: PubMed 22337488Moazzam 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.
- Background: PubMed 22219004Vaidya 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.
- Background: PubMed 22048183Vaidya 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.
- Background: PubMed 2380212Majeed 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.
- PROMIS outcome questionnairesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zlowodzki, MD principal investigator
Indiana University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Fixator and Symphyseal Plate in people with Anterior Pelvic Ring Injury With Symphysis Disruption, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principle Investigator left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcomes (time frame: 24 hours - 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399319, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.