Distal Targeter vs Free-hand

April 8, 2025 updated by: Carol A. Lin, MD, Cedars-Sinai Medical Center

A Randomized Controlled Trial Comparing Free-Hand Versus Distal Targeting Jig-Based for Distal Interlock Screw Placement

This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. However, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. Newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. Proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. This study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old and above
  • Undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion

Exclusion Criteria:

  • Prior ipsilateral tibial or femoral nail
  • Patients who cannot have interlocking screws placed
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Free-hand/perfect circles
Patients in this group will have interlocking screw placement using a free-hand, perfect circles technique.
Procedure: Free-hand/perfect circles technique
Patients in this arm will have no assistive targeting device use and the surgeon will use a free-hand technique for the placement of interlocking screws. With this technique, fluoroscopic images are taken such that the interlocking holes of the intramedullary device are "perfect circles" and indicate that a screw introduced in the same plane that the fluoroscopic image was taken would seat perpendicularly to the intramedullary device. This is the most commonly employed technique for interlocking screw placement through intramedullary devices.
Experimental: Distal targeting jig
Patients in this group will have interlocking screw placement using a proximally placed distal targeting jig
Device: Distal targeting jig
Patients in this arm will have an assistive targeting device used for interlocking screw placement. The targeting device is attached to the nail proximally or distally (for antegrade or retrograde nailing, respectively) to guide screw placement through the other end of the intramedullary device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of Screw Placement Angle
Time Frame: Intraoperatively (at end of surgery)
Correct screw placement is at a right (90-degree) angle from the intramedullary nail, through the interlocking screw hole
Intraoperatively (at end of surgery)
Patient Radiation Exposure
Time Frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Number of fluoroscopic images taken intraoperatively for screw placement and cumulative radiation exposure (in grays)
During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Total Screw Placement Time
Time Frame: During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)
time taken to place interlocking screws
During surgery: the first fluoroscopy shot to localize the jig or obtain a perfect circle (start) to the last shot to confirm complete seating of the screw (end time)
Amount of Cumulative Radiation Exposure (in Grays)
Time Frame: During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement
Total radiation exposure during distal screw placement
During surgery: The first fluoroscopy shot for distal interlocking screw placement to final fluoroscopy shot confirming the final screw's placement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Learning curve
Time Frame: Through study completion (6 month study period)
learning curve between distal targeter and freehand techniques stratified by level of training
Through study completion (6 month study period)
Training methods
Time Frame: Through study completion (6 month study period)
Correlation of sawbones-based practice and clinical practice for interlocking screw placement with regards to time taken for screw placement and accuracy of screw placement (deviation from right angle relative to intramedullary device)
Through study completion (6 month study period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Nordic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001778

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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