Incidence and risk of Nail Breakage in patients implanted with the DePuy Synthes TFN-ADVANCED™ Proximal Femoral Nailing System (TFNA)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Medical condition to be studied:
  Femur fracture

Population studied

• Short description of the study population:
  Study population included patients with femur fracture undergoing surgical repair with a cephalomedullary nail system in an inpatient setting identified from the Premier healthcare database from January 2010 to September 2019.; Inclusion Criteria: Cephalomedullary Nail Overall Cohort; • >21 years*, AND; • have an ICD-9/10 procedure code for femur fracture repair with internal fixation device, AND; • be treated surgically with a TFN, TFNA, Stryker Gamma3 or Zimmer Natural Nail cephalomedullary nail in an inpatient setting between January 1, 2010, and September 30, 2019 or most recent data (index procedure); ; Inclusion Criteria: Cephalomedullary Nail Sub-cohort; • >21 years*, AND; • have an ICD-9/10 procedure code for femur fracture repair with internal fixation device, AND; • be treated surgically with TFNA, Stryker Gamma 3 or Zimmer Natural Nail cephalomedullary nail in an inpatient setting between February 1, 2014 and September 30, 2019 or most recent data (index procedure) ; *Age 21 and older was selected to be in alignment with the TFNA indication, which is for the treatment of fractures in adults and adolescents in which the growth plates have fused.; ; Exclusion Criteria: Cephalomedullary Nail Overall Cohort & Cephalomedullary Nail Sub cohort; • Missing age or sex on index date; • Presence of nail breakage ICD9/10 diagnosis code on index date
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with femur fracture
• Estimated number of subjects:
  12000

Study design details

• Main study objective:
  To estimate the incidence rate and the relative risk of nail breakage among patients implanted with the DePuy Synthes TFNA Proximal Nailing System compared to patients implanted with selected nails designed to provide cephalomedullary support to a proximal femoral fracture, the Stryker Gamma3 Nail System or Zimmer Natural Nail System.
• Outcomes:
  Nail breakage, defined as ≥1 ICD-9/10 diagnosis code for breakdown of internal device AND ≥1 ICD-9/10 procedure code for femur fracture repair or device removal from femur co-occuring within the same inpatient hospitalization with admission date between index date + 1 day and index date + 18 months
• Data analysis plan:
  Descriptive statistics on baseline characteristics with comparison between exposure groups, Unadjusted incidence rate for nail breakage, Multivariate Cox Regression to determine HRs with 95% CI, Sensitivity analyses

Documents

Study publications

Wallace A, Amis J, Cafri G, Coplan P, Wood J. Comparative Safety of the TFN-ADV…