Clinical trial NCT02422355: A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
Official title: A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fracture
Hip Fracture
Keywords: hip
femoral neck
Garden classification
healing
cut-out
iatrogenic fracture
implant
rotational stability
minimal invasive
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from a femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of complications within the first 3 months after surgery
timeFrame: 3 months
Secondary outcomes:
measure: Fracture mechanism
timeFrame: Pre-operatively (Day -1)
measure: Classification of the fracture
timeFrame: Pre-operatively (Day -1)
measure: Time from injury to surgery
timeFrame: Surgery (Day 0)
measure: Length of surgery
timeFrame: Surgery (Day 0)
measure: Harris Hip Score
timeFrame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
measure: EQ5D-5L
timeFrame: Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery
measure: Radiological bone union (RUSH score)
timeFrame: 6 weeks, 3 months, 6 months and 12 months after surgery
measure: Quality of reduction (Garden's alignment index and Lowell's criteria)
timeFrame: Surgery (Day 0)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
state: Tirol
city: Ulm
country: Germany
facility: Ulm University
state: Baden-Württemberg
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität Jena
state: Thüringen
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland
state: BL
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
state: Ticino
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Cantonal Hosptal, Baselland
name: Karl Stoffel, Prof
role: PRINCIPAL_INVESTIGATOR
References: