Trial Outcomes & Findings for The Use of 3D Printing in Orbital Fractures (NCT NCT03673865)
NCT ID: NCT03673865
Last Updated: 2022-07-27
Results Overview
The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Orbital volume measurements will be obtained to compare the injured and uninjured (contralateral) orbital volumes. OsiriX MD offers advanced processing techniques and has the ability to precisely measure orbital volume. It also utilizes the DICOM data from the immediate postoperative CT scans.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
1 hour post operatively
Results posted on
2022-07-27
Participant Flow
Participant milestones
| Measure |
Treatment Group
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of 3D Printing in Orbital Fractures
Baseline characteristics by cohort
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
Total
n=25 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
41.5 years
n=93 Participants
|
38.2 years
n=4 Participants
|
39.9 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African-American
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Medical Comorbidities
Hypertension
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Medical Comorbidities
Diabetes
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Medical Comorbidities
Migraines
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Medical Comorbidities
Asthma
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Medical Comorbidities
Depression
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Etiology
MVC
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Etiology
Fall
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Etiology
Assault
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Etiology
Other
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Laterality
Left
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Laterality
Right
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Location of fracture
Orbital floor fracture
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Location of fracture
Medial wall fracture
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 hour post operativelyThe Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Orbital volume measurements will be obtained to compare the injured and uninjured (contralateral) orbital volumes. OsiriX MD offers advanced processing techniques and has the ability to precisely measure orbital volume. It also utilizes the DICOM data from the immediate postoperative CT scans.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
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Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
Uninjured Orbit
|
23 Cm^3
Standard Deviation 3.5
|
22.8 Cm^3
Standard Deviation 2.6
|
|
Orbital Volume of the Injured Orbit Compared to the Contralateral Uninjured Orbit as Assessed by CT Scan Between the Treatment and Control Groups
Reconstructed Orbit
|
23.5 Cm^3
Standard Deviation 3.2
|
28.6 Cm^3
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.Adequate orbital volume reduction, defined as a reduction of orbital volume to less than 2 cm3. The Primary Investigator will evaluate the orbital volume using OsiriX (medical software). Number of subjects with reduction of orbital volume to less than 2 cm3 between the treatment and control groups are recorded
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
1 week postoperatively.
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
3 weeks postoperatively.
|
13 Participants
|
12 Participants
|
|
Number of Subjects With Reduction of Orbital Volume to Less Than 2 cm3 Between the Treatment and Control Groups
6 weeks postoperatively
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.A difference of more than 2 mm between the two orbits is diagnostic for enophthalmos. Enophthalmos is assessed by clinical examination using a Hertel exophthalmometer. The measurement is taken from the lateral orbital rim to the corneal apex. The normal range is 12-21 mm. Upper normal limit for people of African origin is a little higher, about 23-24 mm. A difference greater than 2 mm between the eyes is significant.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
1 week postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
3 weeks postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With a Difference of More Than 2 mm Between the Two Orbits Between the Treatment and Control Groups
6 weeks postoperatively.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.Infection is defined by the presence of postoperative pus in the wound, a sinus tract or fistula, or elevated white blood cell count (WBC) \>11.0x109/L combined with erythematous skin and swelling on the operated side more than on the un-operated side. WBC is measured with a blood draw test. Infection will be confirmed with clinical examination along with blood tests.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With Infection Between the Treatment and Control Groups
1 week postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Infection Between the Treatment and Control Groups
3 weeks postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Infection Between the Treatment and Control Groups
6 weeks postoperatively.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.Infraorbital nerve injury is assessed by clinical examination using neurosensory testing (NST). NST is a standardized methodology designed to objectively evaluate sensory nerve function. The sensory impairment is determined by 3 levels of testing; each level classifies a specific type of sensory nerve injury.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
1 week postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
3 weeks postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Infraorbital Nerve Injury Between the Treatment and Control Groups
6 weeks postoperatively.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.Intraocular pressure (IOP) \> 40 mmHg is diagnostic of orbital compartment syndrome. Orbital compartment syndrome is assessed through clinical examination using tonometry test. Tonometry is a diagnostic test that measures the pressure inside your eye, which is called intraocular pressure (IOP). The normal pressure range is 12 to 22 mm Hg.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
1 week postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
3 weeks postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Intraocular Pressure (IOP) > 40 mmHg Between the Treatment and Control Groups
6 weeks postoperatively.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Intraoperative time periodOperating time will be calculated from fracture exposure and identification to the final implant placement and fixation and will be recorded in minutes. This will be compared between the two treatment groups. To record and compare the operative time between the two groups, a stopwatch will be utilized.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Mean Operating Time in Minutes Between the Treatment and Control Groups
Length of surgery
|
32.6 minutes
Standard Deviation 13.7
|
53.3 minutes
Standard Deviation 12.8
|
|
Mean Operating Time in Minutes Between the Treatment and Control Groups
Time interval from plate insertion to fixation
|
15.8 minutes
Standard Deviation 14.4
|
41.4 minutes
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: up to 2 weeksIsolated orbital floor fracture patients do not require a pre-operative hospital stay. Length of stay will be calculated in terms of postoperative hospital stay (days). Length of stay in cases of complex orbital fracture will be calculated in terms of pre-operative and postoperative hospital stay (days). The number of days subject stays in the hospital are measured and compared
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Mean Length of Stay in Hospital Measured in Days Between the Treatment and Control Groups
|
1.4 days
Interval 0.0 to 5.0
|
2.1 days
Interval 0.0 to 7.0
|
SECONDARY outcome
Timeframe: up to 2 weeksTreatment charges will be calculated with consideration of the following: 1. Facility operating room charges, which include anesthesia time (surgical time multiplied by the facility rate of $33/ minute). 2. Hardware charges (plates and screws). 3. Length Of Stay charges (LOS multiplied by the facility daily rate of $1,690/ day). 4. The cost of the 3D printed model including the cost of the 3D printer and filaments ($1.5). All treatment charge variables will be provided by the Grady Memorial Hospital Financial Planning and Analysis center. Total treatment charges facility operating room charges, hardware charges, LOS, and the 3D printed model cost will be compared between groups in a manner similar to that outlined in previous studies by our group.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Total Cost
|
3602.54 US Dollars
Standard Deviation 524.63
|
4287.25 US Dollars
Standard Deviation 422.64
|
|
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Cost of Operation Room
|
992.54 US Dollars
Standard Deviation 524.63
|
1,757.25 US Dollars
Standard Deviation 422.64
|
|
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
3D Cost
|
80 US Dollars
Standard Deviation 0
|
0 US Dollars
Standard Deviation 0
|
|
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Length of Stay, Cost
|
1690 US Dollars
Standard Deviation 0
|
1690 US Dollars
Standard Deviation 0
|
|
Mean Treatment Amount in Dollars Between the Treatment and Control Groups
Cost of plate and screws
|
840 US Dollars
Standard Deviation 0
|
840 US Dollars
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 week, 3 weeks, and 6 weeks postoperatively.Extra-ocular motility is assessed through clinical examination. The patient should be able to move the eyes through the six cardinal positions of gaze (left, right, up and right, up and left, down and right, down and left). All patients will be examined for the following: 1. Development of restricted extraocular motility that was not present prior to the surgery. 2. Persistent restriction of extraocular motility after the surgery
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
1 week postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
3 weeks postoperatively.
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Develop Restricted Extraocular Motility That Was Not Present Before Between the Treatment and Control Groups
6 weeks postoperatively.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 hours postoperativelyInability to achieve the normal orbital contour as assessed in the immediate post-operative Computerized Tomography (CT) scan. Maxillofacial non-contrast CT scans according to the protocol will be obtained as part of the standard of care in managing orbital fractures and will be obtained for all subjects post operatively.
Outcome measures
| Measure |
Treatment Group
n=13 Participants
Patients undergo orbital reconstruction using pre-adjusted patient-specific orbital implants with office-based 3-dimensional printers (OB3DP)
office-based 3-dimensional printers (OB3DP): In this treatment group subjects, using office-based 3-dimensional printers (OB3DP) a patient-specific pre-adjusted (pre-bend) orbital plates will be made using over-the-counter titanium plates that are manually adjusted according to the printed model. The plates are then send to sterilization for preparation.
|
Control Group
n=12 Participants
Patients undergo orbital reconstruction with non-patient-specific orbital implants (traditional approach, Control Group) which is a standard stock orbital plate
standard stock orbital plate: In this control group subjects will receive non-patient-specific orbital implants which is standard stock orbital plate that is adapted intraoperatively to the fractured orbit
|
|---|---|---|
|
Number of Subjects With Inability to Achieve the Normal Orbital Contour Between the Treatment and Control Groups
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place