Trial Outcomes & Findings for Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures (NCT NCT02625766)
NCT ID: NCT02625766
Last Updated: 2022-05-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
up to 12 weeks post injury
Results posted on
2022-05-09
Participant Flow
Participant milestones
| Measure |
Operative
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.
LC fracture surgical fixation
|
Non-operative
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.
LC fracture non-operative management
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Baseline characteristics by cohort
| Measure |
Operative
n=47 Participants
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.
LC fracture surgical fixation
|
Non-operative
n=48 Participants
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.
LC fracture non-operative management
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 18.9 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 17.9 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
Underweight (< 18.5 kg/m^2)
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
BMI
Normal (18.5-24.9 kg/m^2)
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
BMI
Overweight (25-29.9 kg/m^2)
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
BMI
Obese (>30 kg/m^2)
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
History of Comorbidities
Comorbidities
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
History of Comorbidities
No Comorbidities
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Mechanism of Injury
Motor Vehicle
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Mechanism of Injury
Fall
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Mechanism of Injury
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Injury Severity Score (ISS)
|
17 scores on a scale
STANDARD_DEVIATION 9 • n=5 Participants
|
18 scores on a scale
STANDARD_DEVIATION 10 • n=7 Participants
|
17 scores on a scale
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Fracture Type
Lateral Compression Type 1
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Fracture Type
Lateral Compression Type 2
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Initial Fracture Displacement
<5 mm (no/minimal displacement)
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Initial Fracture Displacement
5-10 mm (displaced)
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks post injuryThe 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.
Outcome measures
| Measure |
Operative
n=47 Participants
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.
LC fracture surgical fixation
|
Non-operative
n=48 Participants
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.
LC fracture non-operative management
|
|---|---|---|
|
Posttreatment Pain
96 hr
|
5.3 scores on a scale
Standard Deviation 1.8
|
6.2 scores on a scale
Standard Deviation 2.4
|
|
Posttreatment Pain
2 wk
|
4.2 scores on a scale
Standard Deviation 2.0
|
5.6 scores on a scale
Standard Deviation 2.3
|
|
Posttreatment Pain
6 wk
|
2.7 scores on a scale
Standard Deviation 2.6
|
3.5 scores on a scale
Standard Deviation 3.1
|
|
Posttreatment Pain
12 wk
|
1.9 scores on a scale
Standard Deviation 2.0
|
2.9 scores on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: up to 12 weeks post injurySecondary 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.
Outcome measures
| Measure |
Operative
n=47 Participants
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.
LC fracture surgical fixation
|
Non-operative
n=48 Participants
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.
LC fracture non-operative management
|
|---|---|---|
|
Posttreatment Function
2 wk
|
38 percentage of score on a scale
Standard Deviation 11
|
31 percentage of score on a scale
Standard Deviation 10
|
|
Posttreatment Function
6 wk
|
55 percentage of score on a scale
Standard Deviation 18
|
50 percentage of score on a scale
Standard Deviation 18
|
|
Posttreatment Function
12 wk
|
73 percentage of score on a scale
Standard Deviation 20
|
62 percentage of score on a scale
Standard Deviation 22
|
SECONDARY outcome
Timeframe: through patient discharge, up to 12 weeks post injuryLength of hospitalization is determined by recording the admission date versus discharge date for the patient's index hospitalization stay.
Outcome measures
| Measure |
Operative
n=47 Participants
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.
LC fracture surgical fixation
|
Non-operative
n=48 Participants
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.
LC fracture non-operative management
|
|---|---|---|
|
Length of Hospitalization
|
6.9 days
Interval 3.6 to 12.2
|
6.6 days
Interval 3.4 to 12.4
|
SECONDARY outcome
Timeframe: through patient discharge, up to 12 weeks post injuryTime 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.
Outcome measures
| Measure |
Operative
n=47 Participants
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.
LC fracture surgical fixation
|
Non-operative
n=48 Participants
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.
LC fracture non-operative management
|
|---|---|---|
|
Time to First Mobilization Post Injury
|
3 days
Interval 2.0 to 5.0
|
3 days
Interval 2.0 to 4.3
|
Adverse Events
Operative
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-operative
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Operative
n=47 participants at risk
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.
LC fracture surgical fixation
|
Non-operative
n=48 participants at risk
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.
LC fracture non-operative management
|
|---|---|---|
|
Surgical and medical procedures
hardware loosening
|
4.3%
2/47 • Number of events 2 • 1 year
|
0.00%
0/48 • 1 year
|
|
Surgical and medical procedures
Wound seroma requiring drainage
|
2.1%
1/47 • Number of events 1 • 1 year
|
0.00%
0/48 • 1 year
|
|
Surgical and medical procedures
Unplanned fixation
|
0.00%
0/47 • 1 year
|
8.3%
4/48 • Number of events 4 • 1 year
|
Additional Information
Research Administrator
University of Maryland Medical Center
Phone: 4103289579
Email: NO'[email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place