LC Pelvic FractureNCT02625766

Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures

A study testing LC fracture surgical fixation and LC fracture non-operative management in people with LC Pelvic Fracture, run by University of Maryland, Baltimore at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both operative and non-operative treatment can be successful. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: LC Pelvic Fracture
What is being tested?: LC fracture surgical fixation and LC fracture non-operative management
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 2 sitesUnited States
Study dates: 20 Apr 2015to 31 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
The patient is between 18 and 80 years of age, inclusive
The patient has reached skeletal maturity
The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
The patient/family/guardian is English-speaking
The patient's surgeon agrees to randomization (the patient is amendable to either operative or non-operative treatment)
Patient enrollment and, if applicable, patient randomization can occur within 96 hours post injury

Who cannot join

The patient has prior surgical hardware in place that precludes intervention
The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
The patient received prior surgical intervention for his/her current pelvic injury
The patient has sacral morphology that precludes percutaneous fixation
The patient is non-ambulatory due to an associated spinal cord injury
The patient was non-ambulatory pre-injury

Show all 9Show fewer

The patient is currently pregnant
The patient is enrolled in another research study that does not allow co-enrollment
The patient is likely to have severe problems with maintaining follow-up

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland, Shock Trauma Center
Baltimore, Maryland, 21201
Indiana University Health
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial

Read the detailed description

The crux of the problem is determining which of these patients would benefit from early surgical stabilization and which will heal uneventfully without surgery. Many authors site patient pain and inability to mobilize as indications for surgery, although there is conflicting evidence supporting this claim. The presence of chronic pain in the trauma population is a growing area of interest, and there is a push towards controlling pain more effectively in the acute setting. It remains to be proven that surgical intervention is more effective at decreasing acute and longer term pain.

There is evidence in the literature to support both operative and non-operative treatment of patients with LC1 or LC2 pelvic fractures. There is conflicting evidence that surgical stabilization decreases acute pain and narcotic requirements, although patients are often counseled to that effect. The investigators propose to prospectively randomize patients with lateral compression type pelvic fractures to non-operative versus operative treatment and track which group has less pain, less need for narcotic pain medications, and who mobilizes with physical therapy faster.

Conditions: LC Pelvic Fracture
Being tested: LC fracture surgical fixation, LC fracture non-operative management
Keywords: Operative vs. Non-operative, LC pelvic fracture, Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LC fracture surgical fixationProcedure or surgery
LC fracture non-operative managementProcedure or surgery

Study groups in NCT02625766
Study group	Role	What they receive
Operative	Experimental	Patients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms. Receives: Procedure: LC fracture surgical fixation
Non-operative	Experimental	Patients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms. Receives: Procedure: LC fracture non-operative management

What is being measured

The primary outcome is the main question the study is designed to answer.

Posttreatment Pain
The primary outcome was patient-reported pain severity, as measured by the mean of the 4 pain severity items of the Brief Pain Inventory (BPI): worst pain in the last 24 hours, least pain in the last 24 hours, pain on average, and pain right now. The BPI uses a 0-10 level visual analog scale (VAS) with a 24-hour recall period, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The minimum clinically important difference (MCID) is not definitively established for the BPI in a trauma population; however, the MCID for other 10-point VAS pain scales has been reported between 1.0-2.5 points.
Measured: up to 12 weeks post injury

Secondary outcomes (3)

Posttreatment Function
Secondary functional outcome was measured by the Majeed pelvic score. The Majeed pelvic score is a seven-item patient-reported outcome instrument that measures pain, work status, sitting comfort, sexual intercourse, use of walking aids, gait disturbance, and walking distance. The score is reported as a percentage of the highest possible score to adjust for participants who were not employed before their injury. Higher scores represent better function, and a score of >85% has been suggested to represent excellent function.
Measured: up to 12 weeks post injury
Length of Hospitalization
Length of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.
Measured: through patient discharge, up to 12 weeks post injury
Time to First Mobilization Post Injury
Time to first mobilization (bed to chair) is determined using the physical therapy notes during the patient's index hospitalization and is recorded as the number of days post injury that mobilization first occurred.
Measured: through patient discharge, up to 12 weeks post injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201531 Dec 2020

First posted9 Dec 2015 (estimated)
Study start20 Apr 2015
Primary completion10 Dec 2018
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for LC Pelvic FractureStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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: Parallel groups
Masking: None (open label)
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02625766
Sponsor's protocol ID: HP-00060038
Status last verified: Apr 2022
First submitted: 19 Nov 2015
Last updated: 9 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Young JW, Burgess AR, Brumback RJ, Poka A. Lateral compression fractures of the pelvis: the importance of plain radiographs in the diagnosis and surgical management. Skeletal Radiol. 1986;15(2):103-9. doi: 10.1007/BF00350202.
PubMed 3961516
Manson T, O'Toole RV, Whitney A, Duggan B, Sciadini M, Nascone J. Young-Burgess classification of pelvic ring fractures: does it predict mortality, transfusion requirements, and non-orthopaedic injuries? J Orthop Trauma. 2010 Oct;24(10):603-9. doi: 10.1097/BOT.0b013e3181d3cb6b.
PubMed 20871246
Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. doi: 10.1080/17453670510041754.
PubMed 16263614
Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005.
PubMed 7623172
Bruce B, Reilly M, Sims S. OTA highlight paper predicting future displacement of nonoperatively managed lateral compression sacral fractures: can it be done? J Orthop Trauma. 2011 Sep;25(9):523-7. doi: 10.1097/BOT.0b013e3181f8be33.
PubMed 21857419
Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.
PubMed 24740110
Kanakaris NK, Angoules AG, Nikolaou VS, Kontakis G, Giannoudis PV. Treatment and outcomes of pelvic malunions and nonunions: a systematic review. Clin Orthop Relat Res. 2009 Aug;467(8):2112-24. doi: 10.1007/s11999-009-0712-2. Epub 2009 Jan 30.
PubMed 19184260
Barei DP, Shafer BL, Beingessner DM, Gardner MJ, Nork SE, Routt ML. The impact of open reduction internal fixation on acute pain management in unstable pelvic ring injuries. J Trauma. 2010 Apr;68(4):949-53. doi: 10.1097/TA.0b013e3181af69be.
PubMed 19996807
Tosounidis T, Kanakaris N, Nikolaou V, Tan B, Giannoudis PV. Assessment of Lateral Compression type 1 pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable? Int Orthop. 2012 Dec;36(12):2553-8. doi: 10.1007/s00264-012-1685-4. Epub 2012 Oct 25.
PubMed 23096135
Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.
PubMed 21857421
McKibben NS, O'Hara NN, Slobogean GP, Gaski GE, Nascone JW, Sciadini MF, Natoli RM, McKinley T, Virkus WW, Sorkin AT, Howe A, O'Toole RV, Levy JF. Work Productivity Loss After Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2024 Jan 1;38(1):42-48. doi: 10.1097/BOT.0000000000002681.
PubMed 37653607
Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088.
PubMed 33993178

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures: a Prospective Trial
ClinicalTrials.gov ID: NCT02625766
Acronym / sponsor ID: HP-00060038
Conditions: LC Pelvic Fracture
Keywords: Operative vs. Non-operative, LC pelvic fracture, Complications
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Indiana University Health
Study start: 20 Apr 2015 (actual)
Primary completion: 10 Dec 2018 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 9 Dec 2015 (estimated)
Results: Posted 8 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Operative	Experimental	Procedure: LC fracture surgical fixationPatients enrolled in the operative treatment group will undergo surgical intervention for their pelvic fracture. The surgeon will decide the best surgical technique as per standard of care for the patient's injury. The patient will mobilize as per the surgeon's instructions and x-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly. If additional surgery is required or other complications arise, this will be recorded within the study follow-up forms.
Non-operative	Experimental	Procedure: LC fracture non-operative managementPatients enrolled in the non-operative treatment group will not undergo surgical intervention for their pelvic fracture. They will mobilize as per the surgeon's instructions according to standard of care of for this injury. X-rays will be taken at follow-up clinic appointments to determine if the injury is healing properly or if the pelvis has shifted and may warrant surgical intervention. If complications arise and/or surgery is required, crossover will be allowed and recorded within study follow-up forms.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

The patient has one of the following pelvic fractures (includes bilateral sacral fractures): Lateral compression type 1, Lateral compression type 2, Lateral compression type 3
The patient is between 18 and 80 years of age, inclusive
The patient has reached skeletal maturity
The patient's pelvic fracture is a result of trauma (includes polytraumatized patients)
The patient/family/guardian is English-speaking

Key exclusion criteria (9 listed)

The patient has prior surgical hardware in place that precludes intervention
The patient's pelvic fracture is classified as a Lateral compression type 1 and the associated sacral fracture is incomplete as indicated by failure to violate both the anterior and posterior cortex
The patient received prior surgical intervention for his/her current pelvic injury
The patient has sacral morphology that precludes percutaneous fixation
The patient is non-ambulatory due to an associated spinal cord injury

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
LC fracture surgical fixation	Procedure or surgery	Operative
LC fracture non-operative management	Procedure or surgery	Non-operative

Primary outcome

Posttreatment Pain
Time frame: up to 12 weeks post injury
The primary outcome was patient-reported pain severity, as measured by the mean of the 4 pain severity items of the Brief Pain Inventory (BPI): worst pain in the last 24 hours, least pain in the last 24 hours, pain on average, and pain right now. The BPI uses a 0-10 level visual analog scale (VAS) with a 24-hour recall period, where 0 anchors "no pain" and 10 anchors "pain as bad as you can imagine." The minimum clinically important difference (MCID) is not definitively established for the BPI in a trauma population; however, the MCID for other 10-point VAS pain scales has been reported between 1.0-2.5 points.

3 secondary outcomes

Posttreatment Function
Time frame: up to 12 weeks post injury
Length of Hospitalization
Time frame: through patient discharge, up to 12 weeks post injury
Time to First Mobilization Post Injury
Time frame: through patient discharge, up to 12 weeks post injury

Results and safety

Results posted to the registry on 8 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Operative	47	47
Non-operative	48	48

Primary outcome: Posttreatment Pain

Time frame: up to 12 weeks post injury. Mean (Standard Deviation). Unit: scores on a scale

Measure	Operative n = 47	Non-operative n = 48
96 hr	5.3 (1.8)	6.2 (2.4)
2 wk	4.2 (2.0)	5.6 (2.3)
6 wk	2.7 (2.6)	3.5 (3.1)
12 wk	1.9 (2.0)	2.9 (2.7)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47
Non-operative	0 of 48 (0%)	4 of 48 (8.3%)	0 of 48

Limitations and caveats (from the sponsor): The limitations of the trial are primarily related to its sample size and challenges with recruitment into a randomized controlled trial. The decision to enroll patients who refused randomization, but selected their treatment without surgeon's recommendation, was a study design decision carefully made to balance potential risks of bias with the benefits of increased study power from a larger sample size. Additionally, we acknowledge that we were unable to obtain preoperative pain scores.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3961516Young JW, Burgess AR, Brumback RJ, Poka A. Lateral compression fractures of the pelvis: the importance of plain radiographs in the diagnosis and surgical management. Skeletal Radiol. 1986;15(2):103-9. doi: 10.1007/BF00350202.
Background: PubMed 20871246Manson T, O'Toole RV, Whitney A, Duggan B, Sciadini M, Nascone J. Young-Burgess classification of pelvic ring fractures: does it predict mortality, transfusion requirements, and non-orthopaedic injuries? J Orthop Trauma. 2010 Oct;24(10):603-9. doi: 10.1097/BOT.0b013e3181d3cb6b.
Background: PubMed 16263614Lindahl J, Hirvensalo E. Outcome of operatively treated type-C injuries of the pelvic ring. Acta Orthop. 2005 Oct;76(5):667-78. doi: 10.1080/17453670510041754.
Background: PubMed 7623172Routt ML Jr, Kregor PJ, Simonian PT, Mayo KA. Early results of percutaneous iliosacral screws placed with the patient in the supine position. J Orthop Trauma. 1995 Jun;9(3):207-14. doi: 10.1097/00005131-199506000-00005.
Background: PubMed 21857419Bruce B, Reilly M, Sims S. OTA highlight paper predicting future displacement of nonoperatively managed lateral compression sacral fractures: can it be done? J Orthop Trauma. 2011 Sep;25(9):523-7. doi: 10.1097/BOT.0b013e3181f8be33.
Background: PubMed 24740110Gaski GE, Manson TT, Castillo RC, Slobogean GP, O'Toole RV. Nonoperative treatment of intermediate severity lateral compression type 1 pelvic ring injuries with minimally displaced complete sacral fracture. J Orthop Trauma. 2014 Dec;28(12):674-80. doi: 10.1097/BOT.0000000000000130.
Background: PubMed 19184260Kanakaris NK, Angoules AG, Nikolaou VS, Kontakis G, Giannoudis PV. Treatment and outcomes of pelvic malunions and nonunions: a systematic review. Clin Orthop Relat Res. 2009 Aug;467(8):2112-24. doi: 10.1007/s11999-009-0712-2. Epub 2009 Jan 30.
Background: PubMed 19996807Barei DP, Shafer BL, Beingessner DM, Gardner MJ, Nork SE, Routt ML. The impact of open reduction internal fixation on acute pain management in unstable pelvic ring injuries. J Trauma. 2010 Apr;68(4):949-53. doi: 10.1097/TA.0b013e3181af69be.
Background: PubMed 23096135Tosounidis T, Kanakaris N, Nikolaou V, Tan B, Giannoudis PV. Assessment of Lateral Compression type 1 pelvic ring injuries by intraoperative manipulation: which fracture pattern is unstable? Int Orthop. 2012 Dec;36(12):2553-8. doi: 10.1007/s00264-012-1685-4. Epub 2012 Oct 25.
Background: PubMed 21857421Sagi HC, Coniglione FM, Stanford JH. Examination under anesthetic for occult pelvic ring instability. J Orthop Trauma. 2011 Sep;25(9):529-36. doi: 10.1097/BOT.0b013e31822b02ae.
Derived from this study: PubMed 37653607McKibben NS, O'Hara NN, Slobogean GP, Gaski GE, Nascone JW, Sciadini MF, Natoli RM, McKinley T, Virkus WW, Sorkin AT, Howe A, O'Toole RV, Levy JF. Work Productivity Loss After Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2024 Jan 1;38(1):42-48. doi: 10.1097/BOT.0000000000002681.
Derived from this study: PubMed 33993178Slobogean GP, Gaski GE, Nascone J, Sciadini MF, Natoli RM, Manson TT, Lebrun C, McKinley T, Virkus WW, Sorkin AT, Brown K, Howe A, Rudnicki J, Enobun B, O'Hara NN, Gill J, O'Toole RV. A Prospective Clinical Trial Comparing Surgical Fixation Versus Nonoperative Management of Minimally Displaced Complete Lateral Compression Pelvis Fractures. J Orthop Trauma. 2021 Nov 1;35(11):592-598. doi: 10.1097/BOT.0000000000002088.

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.

Robert O'Toole, MD principal investigator

University of Maryland

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LC fracture surgical fixation and LC fracture non-operative management in people with LC Pelvic Fracture, run by University of Maryland, Baltimore at 2 sites 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Posttreatment Pain (time frame: up to 12 weeks post injury). 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 NCT02625766, which also lists 12 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 9 May 2022.