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New metal nail helps heal broken thighs

NCT ID NCT04015154

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a new metal rod (nail) works for fixing broken thigh bones. About 50 adults with a broken femur were treated with this nail and followed for a year. The goal was to see if they could walk and move their leg as well as people who got an older version of the nail.

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

53 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2025

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.

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 PF of the T2 Alpha Femur Antegrade GT/PF Nailing System in accordance with the following legally cleared/ approved Indications for Use: Indications for Use: * 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

  • St. Cloud Orthopedic Associates, Ltd

    Sartell, Minnesota, 56377, United States

  • UC Health

    Cincinnati, Ohio, 45229, United States

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