FNS (FEMORAL NECK SYSTEM) Study

NCT04577261 | Completed

• 1 other identifier: IRB00066583
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Femoral Neck Fractures

Keywords

neck fractures; implant failure; osteotomy

Outcome Measures

Primary Outcomes (1)

• Re-operation rate

  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 Outcomes (13)

• Timed Up and Go (TUG) time

  Week 6, Months 3, 6, and 12

• European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Score

  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

  Baseline, Week 6, Months 3, 6, and 12

• Visual Analogue Scale (VAS) for Pain Score

  Baseline, Week 6, Months 3, 6, and 12

• Number of Participants with Quality of Fracture Reduction

  Baseline, Week 6, Months 3, 6, and 12

Study Arms (1)

Femoral Neck System (FNS) Participants

Participants who will undergo surgery to treat a fractured femoral neck using the FNS (Femoral Neck System)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• Kenan S, Gold A, Salai M, Steinberg E, Ankory R, Chechik O. Long-Term Outcomes Following Reduction and Fixation of Displaced Subcapital Hip Fractures in the Young Elderly. Isr Med Assoc J. 2015 Jun;17(6):341-5.

  PMID: 26233991 BACKGROUND

• Han S, Oh M, Yoon S, Kim J, Kim JW, Chang JS, Ryu JS. Risk Stratification for Avascular Necrosis of the Femoral Head After Internal Fixation of Femoral Neck Fractures by Post-Operative Bone SPECT/CT. Nucl Med Mol Imaging. 2017 Mar;51(1):49-57. doi: 10.1007/s13139-016-0443-8. Epub 2016 Aug 11.

  PMID: 28250858 BACKGROUND

• Farooq MA, Orkazai SH, Okusanya O, Devitt AT. Intracapsular fractures of the femoral neck in younger patients. Ir J Med Sci. 2005 Oct-Dec;174(4):42-5. doi: 10.1007/BF03168981.

  PMID: 16445160 BACKGROUND

• Campenfeldt P, Hedstrom M, Ekstrom W, Al-Ani AN. Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Injury. 2017 Dec;48(12):2744-2753. doi: 10.1016/j.injury.2017.10.028. Epub 2017 Oct 18.

  PMID: 29106948 BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Eben A Carroll, MD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: October 7, 2020
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)