Femoral Neck FractureFR_FNSNCT02422355
A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
An observational study of Femoral Neck Fracture and Hip Fracture, run by AO Innovation Translation Center at 7 sites in 3 countries.
Trial summary
In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fracture, Hip Fracture
- What is being tested?
- FNS
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 30 Sep 2017to 31 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from a femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
Who may be able to join
- Age 18 years and older
- Diagnosis of a medial femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
- Ability to understand the content of the patient information/Informed Consent Form
- Willingness and ability to participate in the registry according to the Registry Plan (RP)
- Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent
Who cannot join
- Pathological fracture
- Additional acute fracture
- Any not medically managed severe systemic disease
- Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the registry period
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Switzerland4 sites
Kantonsspital Baselland
Bruderholz, Basel-Landschaft, 4401
Luzerner Kantonsspital
Lucerne, 6006
Ospedale Regionale di Lugano
Lugano, Canton Ticino, 6900
Stadtspital Triemli
Zurich, 8063
Germany2 sites
Friedrich-Schiller-Universität Jena
Jena, Thuringia, 07740
Ulm University
Ulm, Baden-Wurttemberg, 89081
About this study
In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
Read the detailed description
All patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. Data of a visit after 6 months and 12 months are collected if bone union according to the RUSH score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site.
Preoperative:
- Patient details
- Fracture Classification and comminution based on CT
- Pre-fracture HHS and EQ5D
- X-rays
Intraoperative:
- Surgery details
- Defined intraoperative complications
- Intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement
Postoperative:
- X-ray prior to any mechanical load: hip ap (with leg 15° internally rotated) and lateral 6 weeks and 3 months FU:
- Defined postoperative complications
- HSS and EQ5D
- X-rays
- Conditions
- Femoral Neck Fracture, Hip Fracture
- Being tested
- FNS
- Keywords
- hip, femoral neck, Garden classification, healing, cut-out, iatrogenic fracture, implant, rotational stability, minimal invasive
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNSDevice
Surgical intervention using the FNS
| Study group | Role | What they receive |
|---|---|---|
| Femoral Neck Fractures AO/OTA 31-B1:3 | Fixation using the implant FNS. Receives: Device: FNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications within the first 3 months after surgery
Measured: 3 months
Secondary outcomes (8)
Fracture mechanism
Classification of the fracture mechanism in one of the following group: Fall from standing height , Falls from elevated height, Road traffic accident or Other causes
Measured: Pre-operatively (Day -1)
Classification of the fracture
Classification of the fracture using the Garden classification and the AO/AOTA classification
Measured: Pre-operatively (Day -1)
Time from injury to surgery
Time in hours from the injury to the start of the surgery
Measured: Surgery (Day 0)
Length of surgery
Time in minutes from first incision to closure
Measured: Surgery (Day 0)
Harris Hip Score
Measured: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
EQ5D-5L
Measured: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Radiological bone union (RUSH score)
RUSH score
Measured: 6 weeks, 3 months, 6 months and 12 months after surgery
Quality of reduction (Garden's alignment index and Lowell's criteria)
Garden's alignment index and Lowell's criteria
Measured: Surgery (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start30 Sep 2017
- Primary completion30 Nov 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Stoffel, Prof, Principal investigator, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422355
- Sponsor's protocol ID
- FR FNS
- Acronym
- FR_FNS
- Status last verified
- Dec 2021
- First submitted
- 27 Mar 2015
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stoffel K, Michelitsch C, Arora R, Babst R, Candrian C, Eickhoff A, Gebhard F, Platz A, Schmid FA, Weschenfelder W, Sommer C. Clinical performance of the Femoral Neck System within 1 year in 125 patients with acute femoral neck fractures, a prospective observational case series. Arch Orthop Trauma Surg. 2023 Jul;143(7):4155-4164. doi: 10.1007/s00402-022-04686-w. Epub 2022 Dec 2.
PubMed 36460761
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT02422355
- Acronym / sponsor ID
- FR_FNS / FR FNS
- Conditions
- Femoral Neck Fracture, Hip Fracture
- Keywords
- hip, femoral neck, Garden classification, healing, cut-out, iatrogenic fracture, implant, rotational stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In comparison to previous implants, the Femoral neck system (FNS) is an approved implant by the competent authorities (CE mark). It is designated to stabilize medial femoral neck fractures in a minimal invasive technique. The implant combines an angular stable device with screw in screw technology for rotational stability. Therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called FNS is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.
Detailed description
All patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. Data of a visit after 6 months and 12 months are collected if bone union according to the RUSH score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site.
Preoperative:
- Patient details
- Fracture Classification and comminution based on CT
- Pre-fracture HHS and EQ5D
- X-rays
Intraoperative:
- Surgery details
- Defined intraoperative complications
- Intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement
Postoperative:
- X-ray prior to any mechanical load: hip ap (with leg 15° internally rotated) and lateral 6 weeks and 3 months FU:
- Defined postoperative complications
- HSS and EQ5D
- X-rays
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral Neck Fractures AO/OTA 31-B1:3 | – | Device: FNSFixation using the implant FNS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from a femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
Key inclusion criteria (5 listed)
- Age 18 years and older
- Diagnosis of a medial femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
- Ability to understand the content of the patient information/Informed Consent Form
- Willingness and ability to participate in the registry according to the Registry Plan (RP)
- Signed and dated Ethics Committee (EC)/Institutional Review Board (IRB) approved written informed consent
Key exclusion criteria (7 listed)
- Pathological fracture
- Additional acute fracture
- Any not medically managed severe systemic disease
- Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy or women planning to conceive within the registry period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNSSurgical intervention using the FNS | Device | Femoral Neck Fractures AO/OTA 31-B1:3 |
Primary outcome
Number of complications within the first 3 months after surgery
Time frame: 3 months
8 secondary outcomes
Fracture mechanism
Time frame: Pre-operatively (Day -1)
Classification of the fracture
Time frame: Pre-operatively (Day -1)
Time from injury to surgery
Time frame: Surgery (Day 0)
Length of surgery
Time frame: Surgery (Day 0)
Harris Hip Score
Time frame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
EQ5D-5L
Time frame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
Radiological bone union (RUSH score)
Time frame: 6 weeks, 3 months, 6 months and 12 months after surgery
Quality of reduction (Garden's alignment index and Lowell's criteria)
Time frame: Surgery (Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 36460761Stoffel K, Michelitsch C, Arora R, Babst R, Candrian C, Eickhoff A, Gebhard F, Platz A, Schmid FA, Weschenfelder W, Sommer C. Clinical performance of the Femoral Neck System within 1 year in 125 patients with acute femoral neck fractures, a prospective observational case series. Arch Orthop Trauma Surg. 2023 Jul;143(7):4155-4164. doi: 10.1007/s00402-022-04686-w. Epub 2022 Dec 2.
- Sponsor's websiteLink provided by the sponsor.
Related trials for Femoral Neck Fracture
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Stoffel, Prof principal investigator
Cantonal Hospital, Baselland
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fracture and Hip Fracture, run by AO Innovation Translation Center at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complications within the first 3 months after surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02422355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.