A Phase 4 interventional study of Calcium Sulfate and PMMA in Open tíbia Fracture With Sub-segmental Bone Loss, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by University of Washington · Phase 4, Interventional, and Treatment
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 1 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Calcium Sulfate
Drug: PMMA
Other: No treatment
Calcium Sulfate with abx will be used in the defect
PMMA with abx will be used in the defect
The defect will not be treated
Number of Patients With a Nonunion
Radiographic healing at one year with no additional surgery
Time frame: One Year
| Milestone | Calcium Sulphate | PMMA | Nothing |
|---|---|---|---|
| Started | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
Radiographic healing at one year with no additional surgery
No measurements were reported for this outcome.
Collected over no one randomized or treated. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calcium Sulphate | — | — | — |
| PMMA | — | — | — |
| Nothing | — | — | — |
project abandoned
| Age, Categorical | Calcium Sulphate | PMMA | Nothing | Total |
|---|---|---|---|---|
| <=18 years | — | — | — | — |
| Between 18 and 65 years | — | — | — | — |
| >=65 years | — | — | — | — |
| Age, Continuous | Calcium Sulphate | PMMA | Nothing | Total |
|---|
| Sex: Female, Male | Calcium Sulphate | PMMA | Nothing | Total |
|---|---|---|---|---|
| Female | — | — | — | — |
| Male | — | — | — | — |
| Race and Ethnicity Not Collected | Calcium Sulphate | PMMA | Nothing | Total |
|---|
| Region of Enrollment(participants) | Calcium Sulphate | PMMA | Nothing | Total |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — there is no plan to share individual data
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Washington