Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New nail designs tracked in leg fracture patients

NCT ID NCT05272631

Disease control Sponsor: DePuy Synthes Products, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracked 241 adults and teens with broken thigh or shin bones who received either a retrograde femoral nail or a tibial nail. The goal was to see how well the bones healed and if patients had pain. Researchers measured healing time and pain scores to confirm the nails are safe and work as intended.

What this could mean

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

Active substance
Retrograde Femoral Nail Advanced and Tibial Nail Advanced (medical devices used in surgery to fix broken leg bones)
What this could lead to
If successful, this registry confirms that these nails are safe and effective for healing leg fractures, supporting their continued use in standard care.
What could go wrong
This is a completed registry, not a controlled trial, so results may not apply to all patients. Healing depends on many factors beyond the nail itself.

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

241 people

The number who actually took part.

Started

May 2022

Finished

Oct 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

The study population includes adults 22 years of age or older, (Retrograde Femoral Nail Advanced \[RFNA\], Tibial Nail Advanced \[TNA\]) or adolescents 12-21 years of age in which the growth plates have fused (TNA only) who will undergo surgery for fixation and stabilization of a tibia, femoral shaft or distal femur fracture, or who require a revision due to a malunion or a nonunion, with either the TNA (tibia) or RFNA (femoral shaft or distal femur).

Ages

12 years and older

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: * Skeletally mature adults age greater than or equal to (\>=) 22 years (Retrograde Femoral Nail Advanced \[RFNA\], Tibial Nail Advanced \[TNA\]) and adolescents 12-21 years of age in which the growth plates have fused (TNA only) * Participant receives an RFNA and/or TNA based on a diagnosis of open or closed, unilateral or bilateral femoral shaft or distal femur fracture (RFNA); unilateral or bilateral tibial fracture (TNA); revision of malunion or nonunion of previous fracture, or impending pathologic fracture (RFNA only) that will be treated operatively as part of standard of care. In addition, the following will be included: a) RFNA only: femoral shaft or distal femur fracture can be periprosthetic (PPFx) fracture after total or unicondylar knee arthroplasty, or total or hemi hip arthroplasty requiring nail osteosynthesis * Participant (legally authorized representative if participant is a minor) voluntarily signs the Institutional Review Board (IRB)/ Ethics committee (EC) approved consent form * Participant must be able to read and understand questions and responses in an available translated language for patient reported outcomes (PROs) Exclusion Criteria: * Participation in any other medical device or medicinal product study within the previous month. Participation in observational studies is allowed * In the opinion of the Principal Investigator, participant is unable to comply with the requirements of the Registry * Participant has known allergies to implant components

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Femoral fracture are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Femoral Fractures femoral neck fracture hip fracture tibia fracture

As listed by the trial registrant

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

Femoral fractures Tibial fractures

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27705, United States

  • JPS Health Network

    Fort Worth, Texas, 76104, United States

  • Michigan Medicine; University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Orthopedic Research Foundation, Inc

    Indianapolis, Indiana, 46278, United States

  • University of Missouri

    Columbia, Missouri, 65211, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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