FNS (FEMORAL NECK SYSTEM) Study (FNS)

April 28, 2026 updated by: Wake Forest University Health Sciences

A Prospective Study To Evaluate The FEMORAL NECK SYSTEM (FNS) In The Treatment Of INTRA-CAPSULAR FEMORAL Neck Fractures

A post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the Femoral Neck System (FNS)™

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.

Detailed Description

To evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™ at one year post-operation. The Femoral Neck System (FNS)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. These implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. The FNS system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model

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.
Observational

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.
43

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Femoral Neck System (FNS) Participants
Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System)

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
Re-operation rate
Time Frame: Year 1 post-operation
Re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the Femoral Neck System (FNS)™
Year 1 post-operation

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
Timed Up and Go (TUG) time
Time Frame: Week 6, Months 3, 6, and 12
The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. Normal healthy elderly usually complete the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. 8
Week 6, Months 3, 6, and 12
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Score
Time Frame: Baseline, Week 6, Months 3, 6, and 12
The EuroQol EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems) The first part (descriptive system with 5 dimensions) is scored using the Health state index scores. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Baseline, Week 6, Months 3, 6, and 12
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) - VAS (Visual Analogue Scale) Score
Time Frame: Baseline, Week 6, Months 3, 6, and 12
The EuroQol EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems), as well as, a Visual Analogue Scale where subjects indicate a numerical value from 0-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state.
Baseline, Week 6, Months 3, 6, and 12
Visual Analogue Scale (VAS) for Pain Score
Time Frame: Baseline, Week 6, Months 3, 6, and 12
The Visual Analogue Scale is simply a line of fixed length, on which the subject marks their experience of pain with a single stroke of a pen - The subject will record their level of pain on a 100 mm visual analog scale - the scale will be marked 'no pain' on the left side of the scale and 'severe pain' at the right end of the scale - It is generally accepted that a pain VAS score of 30, 70, and 100 indicates the upper boundaries of mild, moderate, and severe pain intensity
Baseline, Week 6, Months 3, 6, and 12
Number of Participants with Quality of Fracture Reduction
Time Frame: Baseline, Week 6, Months 3, 6, and 12

Appropriate reduction will be defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. If reduction is acceptable in both views, it will be classified as grade I. Grade II will be indicative of one plane of malreduction, and grade III will be indicative of malreduction in both radiographic views.

Pre-operative radiographs will be reviewed and classified as displaced (e.g. Garden III & IV) or non-displaced (e.g. Garden I & II) femoral neck fractures by the Investigator at each site Pauwel Classification (Type I - 30 degrees, Type II - 50 degrees, Type III - 70 degrees)
Baseline, Week 6, Months 3, 6, and 12
Active Straight Leg Raise (ASLR) Assessment Score
Time Frame: Baseline, Week 6, Months 3, 6, and 12
The ALSR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Subjects will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the subject for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do) -Lower score denotes better outcome
Baseline, Week 6, Months 3, 6, and 12
Number of Participants with Intraoperative complications
Time Frame: Baseline, Week 6, Months 3, 6, and 12
Number of Participants with Intraoperative complications
Baseline, Week 6, Months 3, 6, and 12
Radiographic outcomes including quality of fracture reduction
Time Frame: Baseline, Week 6, Months 3, 6, and 12
Perform radiology imaging collecting both anteroposterior (AP) and lateral images of the target hip to ensure the FNS is properly implanted - (healed, non-union, aligned, mal-union, osteonecrosis of femoral head, no osteonecrosis of femoral head, none)
Baseline, Week 6, Months 3, 6, and 12
Number of Construct failure past 6 months
Time Frame: Months 6 and 12
Construct failure past typical femoral neck fracture healing period (past 6 months)
Months 6 and 12
Time to return to full weight-bearing
Time Frame: Week 6, Months 3, 6, and 12
Time to return to full weight-bearing
Week 6, Months 3, 6, and 12
Ambulatory status from pre-injury to study completion
Time Frame: Baseline, Week 6, Months 3, 6, and 12
Subjects will be assessed as "Unaided", "Using a cane", "Using a walker" or "Bed to Chair"
Baseline, Week 6, Months 3, 6, and 12
Length of hospital stay
Time Frame: Week 6, Months 3, 6, and 12
Length of hospital stay
Week 6, Months 3, 6, and 12
Number of Hospital readmission for any reason
Time Frame: Week 6, Months 3, 6, and 12
Number of Hospital readmission for any reason
Week 6, Months 3, 6, and 12

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.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eben A Carroll, MD, Wake Forest Health Sciences

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 7, 2020

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.
April 2, 2026

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.
April 2, 2026

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).
September 30, 2020

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.
September 30, 2020

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.
October 6, 2020

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.
May 4, 2026

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 28, 2026

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, 2026

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.
  • IRB00066583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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