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New hip fracture fix device shows promise in small study

NCT ID NCT04577261

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new surgical device called the Femoral Neck System (FNS) for fixing a common type of hip fracture. Researchers wanted to see how often patients needed another surgery after the implant. The study included 43 adults with hip fractures and followed them for one year. It was a small, completed study that provides early data on this device's performance.

What this could mean

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

Active substance
Femoral Neck System (a surgical implant device)
What this could lead to
If successful, this device could offer a reliable way to fix hip fractures, reducing the need for repeat surgeries and improving recovery.
What could go wrong
This is a small, completed study with only 43 participants. Results may not apply to all patients, and the device may still have risks like any surgery.

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

43 people

The number who actually took part.

Started

Oct 2020

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Subject has experienced displaced or non-displaced intracapsular femoral neck fracture

Ages

18 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: * The subject must provide written informed consent * The subject must be eighteen (18) years of age or older. * The subject must be willing and able to make all required study visits including one (1) year post-operative follow-up. * The subject must be able to follow instructions. * Subject has experienced displaced or non-displaced intracapsular femoral neck fracture Exclusion Criteria: * Subject with fracture occurring more than 7 days prior to the date of surgery * Subject has more than one fracture on target extremity. * Subject is obese as defined by a Body Mass Index (BMI) \> 45 at the time of surgery. * Subject, in the opinion of the Investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen. * Therapy with another investigational agent within thirty (30) days of Screening or planned therapy with another investigational agent during the course of the study. * Subject has a physical condition that, in the opinion of the Investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). If this is identified at the time of surgery, the subject will be screen failed. * Subject has undergone previous surgery on the target hip. * Current systemic therapy with cytotoxic drugs. * Subjects with a history of poor compliance with medical treatment. * Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

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Conditions

The condition(s) this trial relates to.

femoral neck fracture

As listed by the trial registrant

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

Femoral neck fractures

Contacts and locations

Locations

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

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