A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures

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

• FNS (Device): Surgical intervention using the FNS

Primary outcomes

• Number of complications within the first 3 months after surgery [3 months]

Secondary outcomes

• Fracture mechanism [Pre-operatively (Day -1)]: 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
• Classification of the fracture [Pre-operatively (Day -1)]: Classification of the fracture using the Garden classification and the AO/AOTA classification
• Time from injury to surgery [Surgery (Day 0)]: Time in hours from the injury to the start of the surgery
• Length of surgery [Surgery (Day 0)]: Time in minutes from first incision to closure
• Harris Hip Score [Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery]
• EQ5D-5L [Pre-operatively (Day -1), 6 weeks, 3 months, 6 months and 12 months after surgery]
• Radiological bone union (RUSH score) [6 weeks, 3 months, 6 months and 12 months after surgery]: RUSH score
• Quality of reduction (Garden's alignment index and Lowell's criteria) [Surgery (Day 0)]: Garden's alignment index and Lowell's criteria

Sex: All, ages: 18 Years to any

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

• Results publication: 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. PMID 36460761

• Karl Stoffel, Prof, Principal investigator, Cantonal Hospital, Baselland