An interventional study of Radiation Therapy (XRT) in Elbow Fracture, sponsored by Wake Forest University Health Sciences. Terminated. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
The investigators hypothesized that radiation therapy could be safely administered acutely after elbow trauma, and it would decrease the number of patients that would require surgical excision of heterotopic ossification.
A multi-institutional, prospective randomized clinical trial will be employed to determine if single dose, limited field radiation therapy (XRT) will prevent post-traumatic heterotopic ossification (HO) after open reduction internal fixation of intra-articular distal humerus fractures and fracture-dislocations of the elbow and to assess function of the elbow after XRT and no XRT. Patients will be randomly assigned to one of the two groups(XRT/treatment or no XRT/control) by a computer-generated randomization schedule. Assignment will be in a ratio of 1:1 in a complete block design of 10. Each clinical site will be provided with a separate randomization assignment for each study participant. The treating surgeon and patient will be blinded to group assignment until after operative treatment. Clinical and radiographic assessments at 6 weeks, 3 months and 6 months post-operatively will be performed. The primary clinical outcome will be the Mayo elbow performance score which measures pain, stability, function and motion. Motion parameters (flexion, extension, pronation and supination) will be performed at each data collection point. Primary radiographic outcome will be the presence of heterotopic ossification by plain radiographs of the elbow in the antero-posterior and lateral planes at 6 weeks, 3 months, and 6 months post-operatively. Further imaging (radiograph or CT) will be obtained past the 6-month interval if deemed necessary by the treating physician,or if fracture union was not achieved at 6 months. The presence of HO will be quantified by radiograph. All adverse events will be documented. The trial will be monitored periodically by the Safety Monitor at least twice a year to ensure protocol compliance and address safety issues.
30 studies on the registry are indexed under Ossification, Heterotopic; 8 are open to participants now.
This study's enrollment of 48 is below the median of 63 across 17 interventional studies indexed under Ossification, Heterotopic.
Browse Ossification, Heterotopic studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will not receive radiation therapy after surgery.
Radiotherapy will be administered no later than 72 hours postoperatively.
Radiation: Radiation Therapy (XRT)
The dose will be 700 gray (derived unit of ionizing radiation dose in the International System of Units) in a single fraction, using AP-PA fields calculated to midplane. No Less than 6 MV energy photons will be used, and no bolus is placed on the skin. The field covers the entire joint, the antecubital fossa and the olecranon process. A strip of skin at the antecubital area is generally shielded, but is not an absolute requirement for this study.
Also known as: Treatment group
Mayo Elbow Performance Score
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).
Time frame: 6 month
| Milestone | No Radiation Therapy (XRT) | Radiation Therapy (XRT) |
|---|---|---|
| Started | 26 | 22 |
| Completed | 24 | 21 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
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).
| units on a scale | No Radiation Therapy (XRT) | Radiation Therapy (XRT) |
|---|---|---|
| Mayo Elbow Performance Score | 66 ± 23 | 69 ± 19 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Radiation Therapy (XRT) | — | 0/24 (0%) | 4/24 (16.7%) |
| Radiation Therapy (XRT) | — | 0/21 (0%) | 8/21 (38.1%) |
| Event | No Radiation Therapy (XRT) | Radiation Therapy (XRT) |
|---|---|---|
| Fracture NonunionMusculoskeletal and connective tissue disorders | 4/24 | 8/21 |
| Age, Categorical(Participants) | No Radiation Therapy (XRT) | Radiation Therapy (XRT) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 22 | 48 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | No Radiation Therapy (XRT) | Radiation Therapy (XRT) | Total |
|---|---|---|---|
| Mean | 45 ± 15 | 44 ± 17 | 45 ± 17 |
| Sex: Female, Male(Participants) | No Radiation Therapy (XRT) | Radiation Therapy (XRT) | Total |
|---|---|---|---|
| Female | 15 | 7 | 22 |
| Male | 11 | 15 | 26 |
| Region of Enrollment(participants) | No Radiation Therapy (XRT) | Radiation Therapy (XRT) | Total |
|---|---|---|---|
| United States | 26 | 22 | 48 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Wake Forest University Health Sciences