Back to resultsCalcium Sulfate Spacer in Open Tibia Fractures
Primary Purpose
Open tíbia Fracture With Sub-segmental Bone Loss
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcium Sulfate
PMMA
No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Open tíbia Fracture With Sub-segmental Bone Loss
Eligibility Criteria
Inclusion Criteria:
- Open tibia shaft fracture treated with an IMN
Exclusion Criteria:
- None
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Calcium Sulphate
PMMA
Nothing
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With a Nonunion
Radiographic healing at one year with no additional surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT03042546
First Posted
January 27, 2017
Last Updated
February 7, 2023
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03042546
Brief Title
Calcium Sulfate Spacer in Open Tibia Fractures
Official Title
Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open tíbia Fracture With Sub-segmental Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients are blinded
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium Sulphate
Arm Type
Active Comparator
Arm Title
PMMA
Arm Type
Active Comparator
Arm Title
Nothing
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Calcium Sulfate
Intervention Description
Calcium Sulfate with abx will be used in the defect
Intervention Type
Drug
Intervention Name(s)
PMMA
Intervention Description
PMMA with abx will be used in the defect
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
The defect will not be treated
Primary Outcome Measure Information:
Title
Number of Patients With a Nonunion
Description
Radiographic healing at one year with no additional surgery
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Open tibia shaft fracture treated with an IMN
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Sagi
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to share individual data
Learn more about this trial
Calcium Sulfate Spacer in Open Tibia Fractures
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