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Union Rate of Transverse Tibia Fracture

Primary Purpose

Closed Transverse Fracture of Shaft of Tibia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional Compression
Standard Backslapping
Dynamic Locking with Backslapping
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Transverse Fracture of Shaft of Tibia

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Closed Tibia Shaft Fracture Treated with an IMN

Exclusion Criteria:

  • Unable to consent due to language
  • Unlikely to follow-up for one year

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

Conventional Compression

Standard Backslapping

Dynamic Locking with Backslapping

Arm Description

Nail will be seated using conventional compression technique

Nail will be seated using standard backslapping technique

Nail will be seated using backslapping with dynamic locking

Outcomes

Primary Outcome Measures

Healing of Tibia Fracture by radiographic exam
Healing of Tibia Fracture by radiographic exam

Secondary Outcome Measures

Full Information

First Posted
January 27, 2017
Last Updated
May 29, 2018
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03042533
Brief Title
Union Rate of Transverse Tibia Fracture
Official Title
Union Rates of Transverse Tibia Fractures Managed With Internal Fracture Compression Through an Intramedullary Rod Compared to Standard Backslapping or Backslapping With Dynamic Locking
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
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
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Transverse Fracture of Shaft of Tibia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participant Blinding
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Compression
Arm Type
Active Comparator
Arm Description
Nail will be seated using conventional compression technique
Arm Title
Standard Backslapping
Arm Type
Active Comparator
Arm Description
Nail will be seated using standard backslapping technique
Arm Title
Dynamic Locking with Backslapping
Arm Type
Active Comparator
Arm Description
Nail will be seated using backslapping with dynamic locking
Intervention Type
Device
Intervention Name(s)
Conventional Compression
Intervention Description
Method of Nail fitting
Intervention Type
Device
Intervention Name(s)
Standard Backslapping
Intervention Description
Method of Nail fitting
Intervention Type
Device
Intervention Name(s)
Dynamic Locking with Backslapping
Intervention Description
Method of Nail fitting
Primary Outcome Measure Information:
Title
Healing of Tibia Fracture by radiographic exam
Description
Healing of Tibia Fracture by radiographic exam
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Closed Tibia Shaft Fracture Treated with an IMN Exclusion Criteria: Unable to consent due to language Unlikely to follow-up for one year
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
Currently there is no plan

Learn more about this trial

Union Rate of Transverse Tibia Fracture

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