Trial Outcomes & Findings for Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma (NCT NCT00991887)
NCT ID: NCT00991887
Last Updated: 2022-04-21
Results Overview
Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (\>=90), good (75-89), fair (60-74), and poor (\<60).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
6 month
Results posted on
2022-04-21
Participant Flow
Participant milestones
| Measure |
No Radiation Therapy (XRT)
This group will not receive radiation therapy after surgery.
|
Radiation Therapy (XRT)
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
No Radiation Therapy (XRT)
This group will not receive radiation therapy after surgery.
|
Radiation Therapy (XRT)
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Radiation Therapy for Heterotopic Ossification Prophylaxis Acutely After Elbow Trauma
Baseline characteristics by cohort
| Measure |
No Radiation Therapy (XRT)
n=26 Participants
This group will not receive radiation therapy after surgery.
|
Radiation Therapy (XRT)
n=22 Participants
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 15 • n=5 Participants
|
44 years
STANDARD_DEVIATION 17 • n=7 Participants
|
45 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthPopulation: Patients with elbow trauma treated with radiation therapy in the prevention of post-traumatic heterotopic ossification. Subjects are randomized to either radiation therapy or no radiation therapy.
Mayo Elbow Performance Score (MEPS) is an outcome tool based on a 100 point scale, with higher score indicating better function. It measures pain, stability, function, and motion. The score is graded on the basis of the MEPS as excellent (\>=90), good (75-89), fair (60-74), and poor (\<60).
Outcome measures
| Measure |
No Radiation Therapy (XRT)
n=24 Participants
This group will not receive radiation therapy after surgery.
|
Radiation Therapy (XRT)
n=21 Participants
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
|
|---|---|---|
|
Mayo Elbow Performance Score
|
66 units on a scale
Standard Deviation 23
|
69 units on a scale
Standard Deviation 19
|
Adverse Events
No Radiation Therapy (XRT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Radiation Therapy (XRT)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Radiation Therapy (XRT)
n=24 participants at risk
This group will not receive radiation therapy after surgery.
|
Radiation Therapy (XRT)
n=21 participants at risk
Radiotherapy will be administered no later than 72 hours postoperatively by a board-certified radiation oncologist. It was given as a single fraction at a dose of 700 cGy at 6-MeV energy photons with use of AP-PA (anteroposterior-posterioanterior) field calculated to midplane, with a mean window of 12x8.2cm, for all patients.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fracture Nonunion
|
16.7%
4/24 • Number of events 4
|
38.1%
8/21 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place