No improvement of fixation failure will be found after the introduction of the TFNA
ID
Bron
Verkorte titel
Aandoening
Trochanteric fractures
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Implant related fixation failure
Achtergrond van het onderzoek
The aim of this study was to evaluate failure rates of the TFN-Advanced Proximal Femoral Nailing System (TFNA; DePuy Synthes) versus one of its predecessors and to evaluate the responsible mechanisms of fixation failure.
In 2016 the TFNA was introduced in our institution as successor of the Gamma Trochanteric Nail (GTN3; Stryker). All trochanteric fractures treated surgically from 2011 to 2019 were retrospectively reviewed for fixation failure. Patients suffering from pathologic fractures were excluded. Fixation failure was defined as the occurrence of an implant related complication subclassified as implant cut-out, implant breakage, non-union or malpositioning of the screw/blade. For all cases age, gender, body mass index (BMI), smoking status, comorbidity score (American Society of Anesthesiologists (ASA)), fracture type (AO) and implant positioning (tip-apex-distance) were identified. Missing data were imputed via multiple imputation by chained equations. Propensity score matching was used to balance distributions of covariates and to compare failure rates between TFNA and GTN3 groups.
Doel van het onderzoek
No improvement of fixation failure will be found after the introduction of the TFNA
Onderzoeksopzet
Start 07/2020
Finish 02/2021
Implant related fixation failure and the responsible failure mechanism were defined as the occurrence of (1) implant cut-out, (2) implant breakage, (3) non-union, (4) malpositioning of the screw/blade in the femoral head.
Patients were treated with an intramedullary nail following a trochanteric fracture between June 2011 and July 2019. Electronic files were searched for the occurrence of failure in August 2019.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Trochanteric fracture treated with a TFNA or GTN3 nailing system
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
pathological fracture
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9149 |
Ander register | LHC Rijnstate : 2020-1596 |