Trial Outcomes & Findings for HO Prophylaxis Therapy for Distal Humerus Fractures (NCT NCT03724422)
NCT ID: NCT03724422
Last Updated: 2022-02-15
Results Overview
Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
1 year. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days.
Results posted on
2022-02-15
Participant Flow
Participant milestones
| Measure |
Control
This group will receive the standard of care treatment for their distal humerus fracture only.
|
Intervention
This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.
Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HO Prophylaxis Therapy for Distal Humerus Fractures
Baseline characteristics by cohort
| Measure |
Control
n=1 Participants
This group will receive the standard of care treatment for their distal humerus fracture only.
|
Intervention
n=2 Participants
This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.
Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
42 years
STANDARD_DEVIATION 25.46 • n=7 Participants
|
44.3 years
STANDARD_DEVIATION 18.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
32.7 Kg/m^2
n=5 Participants
|
30.6 Kg/m^2
STANDARD_DEVIATION 16.97 • n=7 Participants
|
31.3 Kg/m^2
STANDARD_DEVIATION 12.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days.Presence of heterotopic ossification on plain radiographs taken in the anteroposterior and lateral planes within 1 year after surgery as quantified using the classification systems described by Brooker, et al. and Hastings and Graham
Outcome measures
| Measure |
Control
n=1 Participants
This group will receive the standard of care treatment for their distal humerus fracture only.
|
Intervention
n=2 Participants
This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.
Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively
|
|---|---|---|
|
Number of Participants With Presence of HO on Humerus
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 year post surgical reduction. The control patient completed 366 days of follow up. The two intervention patients lost follow up after 155 days and 62 days respectively.Rate of non-union of both groups requiring revision surgery.
Outcome measures
| Measure |
Control
n=1 Participants
This group will receive the standard of care treatment for their distal humerus fracture only.
|
Intervention
n=2 Participants
This group will receive the prophylactic radiation therapy in addition to the standard of care treatment of their distal humerus fracture.
Radiation: A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively
|
|---|---|---|
|
Non-union at the Fracture Site.
|
0 Participants
|
0 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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