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Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
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Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Sulphate | Active Comparator |
| |
| PMMA | Active Comparator |
| |
| Nothing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Sulfate | Drug | Calcium Sulfate with abx will be used in the defect |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With a Nonunion | Radiographic healing at one year with no additional surgery | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claude Sagi | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
there is no plan to share individual data
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Only enrolled patient was not randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium Sulphate | Calcium Sulfate: Calcium Sulfate with abx will be used in the defect |
| FG001 | PMMA | PMMA: PMMA with abx will be used in the defect |
| FG002 | Nothing | No treatment: The defect will not be treated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
project abandoned
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium Sulphate | Calcium Sulfate: Calcium Sulfate with abx will be used in the defect |
| BG001 | PMMA | PMMA: PMMA with abx will be used in the defect |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With a Nonunion | Radiographic healing at one year with no additional surgery | project was abandoned as PI left institution | Posted | One Year |
|
no one randomized or treated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Sulphate | Calcium Sulfate: Calcium Sulfate with abx will be used in the defect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| research coordinator | Harboview | 206.744.4406 | bagel@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2016 | Feb 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002133 | Calcium Sulfate |
| D019904 | Polymethyl Methacrylate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D013431 | Sulfates |
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Patients are blinded
| PMMA |
| Drug |
PMMA with abx will be used in the defect |
|
| No treatment | Other | The defect will not be treated |
|
| BG002 | Nothing | No treatment: The defect will not be treated |
| BG003 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | PMMA | PMMA: PMMA with abx will be used in the defect | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Nothing | No treatment: The defect will not be treated | 0 | 0 | 0 | 0 | 0 | 0 |
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| D013464 |
| Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008768 | Methylmethacrylates |
| D011109 | Polymethacrylic Acids |
| D000179 | Acrylates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000180 | Acrylic Resins |
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |