Union Rate of Transverse Tibia Fracture

NCT ID: NCT03042533

Last Updated: 2024-05-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-05-29

Brief Summary

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

Detailed Description

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Conditions

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Closed Transverse Fracture of Shaft of Tibia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant Blinding

Study Groups

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Conventional Compression

Nail will be seated using conventional compression technique

Group Type ACTIVE_COMPARATOR

Conventional Compression

Intervention Type DEVICE

Method of Nail fitting

Standard Backslapping

Nail will be seated using standard backslapping technique

Group Type ACTIVE_COMPARATOR

Standard Backslapping

Intervention Type DEVICE

Method of Nail fitting

Dynamic Locking with Backslapping

Nail will be seated using backslapping with dynamic locking

Group Type ACTIVE_COMPARATOR

Dynamic Locking with Backslapping

Intervention Type DEVICE

Method of Nail fitting

Interventions

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Conventional Compression

Method of Nail fitting

Intervention Type DEVICE

Standard Backslapping

Method of Nail fitting

Intervention Type DEVICE

Dynamic Locking with Backslapping

Method of Nail fitting

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Claude Sagi

Professor, Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claude Sagi

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Harborview Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00001680

Identifier Type: -

Identifier Source: org_study_id

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