Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Intraoperative:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Neck Fractures AO/OTA 31-B1:3 | Fixation using the implant FNS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FNS | Device | Surgical intervention using the FNS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications within the first 3 months after surgery | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre-operatively (Day -1) |
| Classification of the fracture |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients suffering from a femoral neck fracture (AO/OTA 31-B1:3) with the need of a fixation using the FNS.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karl Stoffel, Prof | Cantonal Hosptal, Baselland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | Tyrol | 6020 | Austria | ||
| Ulm University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36460761 | Derived | 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. |
| Label | URL |
|---|---|
| Sponsor's website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Classification of the fracture using the Garden classification and the AO/AOTA classification
| Pre-operatively (Day -1) |
| Time from injury to surgery | Time in hours from the injury to the start of the surgery | Surgery (Day 0) |
| Length of surgery | Time in minutes from first incision to closure | Surgery (Day 0) |
| 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) | RUSH score | 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 | Surgery (Day 0) |
| Ulm |
| Baden-Wurttemberg |
| 89081 |
| Germany |
| Friedrich-Schiller-Universität Jena | Jena | Thuringia | 07740 | Germany |
| Kantonsspital Baselland | Bruderholz | Basel-Landschaft | 4401 | Switzerland |
| Ospedale Regionale di Lugano | Lugano | Canton Ticino | 6900 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6006 | Switzerland |
| Stadtspital Triemli | Zurich | 8063 | Switzerland |
| D007869 |
| Leg Injuries |