Other Clinical Trial - Calcium Sulfate Spacer in Open Tibia NCT03042546

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Terminated

Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

Recruitment information / eligibility
Status	Terminated
Enrollment	1
Est. completion date	May 29, 2018
Est. primary completion date	May 29, 2018
Accepts healthy volunteers	No
Gender	All
Age group	16 Years and older
Eligibility	Inclusion Criteria: - Open tibia shaft fracture treated with an IMN Exclusion Criteria: - None

Drug:
• Calcium Sulfate
Calcium Sulfate with abx will be used in the defect
• PMMA
PMMA with abx will be used in the defect

Other:
• No treatment
The defect will not be treated

Locations
Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors *(1)*
Lead Sponsor	Collaborator
University of Washington

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With a Nonunion	Radiographic healing at one year with no additional surgery	One Year