Forekomst af udskæring ved brug af intramedullære negle med dobbelt cephalic skrue vs. Unik i pertrokantære frakturer
Sammenligning af forekomsten af udskæringer mellem intramedullære negle med dobbelt cephalic skrue vs. unikke i pertrokantære frakturer: et prospektivt randomiseret klinisk forsøg
The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out).
Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Randomized, open and prospective clinical trial.
Following the surgical indication for open reduction and internal fixation as treatment for proximal femoral fractures, patients will be randomly assigned (ratio 1:1) to one of the following treatments:
Control group: a Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture.
Experimental group: a Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture.
Patient (or their legal guardian) must provide/sign the informed consent prior to inclusion in the study.
After the surgery, patients will be followed-up at 6 weeks, 3 and 6 months. At those times, data related to the radiological examination, the appearance of complications and the walking ability evaluation scale (FAC) will be collected.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment.
- Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties.
Exclusion Criteria:
- Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture.
- Subcapital fracture of the proximal femur.
- Subtrochanteric fracture of the proximal femur.
- Pathological fracture.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Single Cephalic Screw System
A Gamma 3 nail (single cephalic screw system) will be used for osteosynthesis of the fracture. |
Open reduction an internal fixation of proximal femoral fracture with a Gamma 3 nail (single cephalic screw system) |
|
Eksperimentel: Double Cephalic Screw System
A Chimaera nail (system with double cephalic screw) will be used for osteosynthesis of the fracture. |
Open reduction an internal fixation of proximal femoral fracture with a Chimaera nail (system with double cephalic screw) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of cut-out.
Tidsramme: 0-6 months
|
Cut-out is a mechanical complication consisting of varus collapse and migration of the cephalic screw through the femoral head. |
0-6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Ambulatory Categories (FAC)
Tidsramme: 0-6 months
|
Classifies patients into 6 categories based on their ability and need for assistance with ambulation. Classifies patients into 6 categories based on their ability and need for help with ambulation, where 0 is equivalent to a patient with the impossibility of ambulation and 5 is a patient completely independent for ambulation. |
0-6 months
|
|
Tip-apex distance
Tidsramme: 3-6 months
|
Distance from the tip of the screw to the apex of the femoral head in the anteroposterior and axial views. |
3-6 months
|
|
Parker index
Tidsramme: 3-6 months
|
Indicates the distance of the screw from the inferior edge of the femoral neck in anteroposterior view or from the posterior edge of the femoral neck in lateral view. |
3-6 months
|
|
Baumgaertner reduction quality criteria
Tidsramme: 3-6 months
|
3 groups are established according to the quality of reduction: good, acceptable and bad |
3-6 months
|
|
Number of Surgical complications (Intraoperative)
Tidsramme: 0-1 month
|
Intraoperative complications |
0-1 month
|
|
Number of Surgical complications (post-operative)
Tidsramme: 0-6 months
|
Postoperative complications |
0-6 months
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Pedro José Torrijos Garrido, MD, PhD, Study Principal Investigator
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CUT-OUT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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