Trial Outcomes & Findings for Heterotopic Ossification Prophylaxis (NCT NCT04867278)
NCT ID: NCT04867278
Last Updated: 2024-12-16
Results Overview
Severe HO formation classified as Brooker class III-IV.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
3 months post-op
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
External Beam Radiation (XRT) With Debridement
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
External Beam Radiation (XRT): Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Debridement: Gluteus minimus debridement in the OR
|
Debridement Alone (Control)
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Debridement: Gluteus minimus debridement in the OR
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
|
Overall Study
COMPLETED
|
54
|
50
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heterotopic Ossification Prophylaxis
Baseline characteristics by cohort
| Measure |
External Beam Radiation (XRT) With Debridement
n=54 Participants
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
External Beam Radiation (XRT): Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Debridement: Gluteus minimus debridement in the OR
|
Debridement Alone (Control)
n=50 Participants
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Debridement: Gluteus minimus debridement in the OR
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11 • n=99 Participants
|
37 years
STANDARD_DEVIATION 13 • n=107 Participants
|
36 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=99 Participants
|
50 participants
n=107 Participants
|
104 participants
n=206 Participants
|
|
Head Injury
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Acetabular fracture dislocation
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Associated fracture pattern
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Surgical Approach: Kocher-Langenbeck
|
49 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Surgical Approach: Combined anterior and posterior
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Trochanteric osteotomy
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Gluteus minimus muscle debridement
|
51 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
NSAIDS for pain management
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Closed suction drain at wound closure
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Tranexamic acid used
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Mechanical ventilation
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months post-opSevere HO formation classified as Brooker class III-IV.
Outcome measures
| Measure |
External Beam Radiation (XRT) With Debridement
n=54 Participants
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
External Beam Radiation (XRT): Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Debridement: Gluteus minimus debridement in the OR
|
Debridement Alone (Control)
n=50 Participants
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Debridement: Gluteus minimus debridement in the OR
|
|---|---|---|
|
Number of Participants With Severe HO Formation
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 months post-opAny HO formation classified as Brooker class I-IV.
Outcome measures
| Measure |
External Beam Radiation (XRT) With Debridement
n=54 Participants
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
External Beam Radiation (XRT): Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Debridement: Gluteus minimus debridement in the OR
|
Debridement Alone (Control)
n=50 Participants
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Debridement: Gluteus minimus debridement in the OR
|
|---|---|---|
|
Number of Participants With Any HO Formation
|
10 Participants
|
17 Participants
|
Adverse Events
External Beam Radiation (XRT) With Debridement
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Debridement Alone (Control)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
External Beam Radiation (XRT) With Debridement
n=54 participants at risk
Patients will receive gluteus minimus debridement in the OR, which is the standard of care at Shock Trauma. If randomized to the treatment group, patients that undergo surgical fixation of an acetabular fracture via a posterior or combined anterior and posterior approach will undergo a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery. This treatment is currently the standard procedure performed for all patients who undergo a posterior or combined approach at our institution.
External Beam Radiation (XRT): Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
Debridement: Gluteus minimus debridement in the OR
|
Debridement Alone (Control)
n=50 participants at risk
The control treatment arm will only include gluteus minimus debridement in the OR and will not receive XRT.
Debridement: Gluteus minimus debridement in the OR
|
|---|---|---|
|
Infections and infestations
Superficial SSI
|
3.7%
2/54 • Number of events 2 • Adverse event data was collected over a period of 3 months post-op for each patient.
|
4.0%
2/50 • Number of events 2 • Adverse event data was collected over a period of 3 months post-op for each patient.
|
|
Infections and infestations
Deep SSI
|
0.00%
0/54 • Adverse event data was collected over a period of 3 months post-op for each patient.
|
2.0%
1/50 • Number of events 1 • Adverse event data was collected over a period of 3 months post-op for each patient.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place