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New thigh bone nail tested for better fracture recovery

NCT ID NCT04015128

Disease control Sponsor: Stryker Trauma and Extremities Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study looks at how well a metal nail system (T2 Alpha Femur Antegrade GT/PF Nail) works for treating broken thigh bones (femur fractures). About 66 adults will receive the nail, and their leg function will be checked after 12 months. The goal is to see if this nail helps people recover as well as older nail designs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System (a metal rod inserted into the thigh bone to stabilize fractures)
What this could lead to
If successful, this study could confirm that this nail system helps people with femur fractures regain leg function as well as or better than existing options.
What could go wrong
This is a small, non-blinded study with only 66 participants, so results may not apply to everyone. As with any surgery, risks include infection, implant failure, or slow healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

66 people

The number who actually took part.

Started

Sep 2019

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 50 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for treatment of femoral fractures will be evaluated for clinical investigation participation based on the eligibility criteria listed above.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject is a male or non-pregnant female age 18 years or older at the time of surgery; * Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan; * Subject is intended to be treated with the Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use: Indications for Use approved Outside of Europe include: * Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures * Femoral fixation required as a result of pathological disease * Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur * Open and closed femoral fractures * Pseudoarthrosis and correction osteotomy * Pathologic fractures, impending pathologic fractures and tumor resections * Ipsilateral femur fractures * Fractures proximal to a total knee arthroplasty * Nonunions and malunions * Fractures involving osteopenic and osteoporotic bone Exclusion Criteria: * Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results; * Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).

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Conditions

The condition(s) this trial relates to.

Femoral Fractures femoral neck fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Femoral fracture

Contacts and locations

Locations

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • Regional One Health

    Memphis, Tennessee, 38103, United States

  • Reno Orthopedic Clinic

    Reno, Nevada, 89503, United States

  • St. Cloud Orthopedic Associates, Ltd

    Sartell, Minnesota, 56377, United States

  • UC Health

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.