Risk of Nail Breakage in Treatment with Cephalomedullary Nails for Proximal Femoral Fractures

Author(s)

Chitnis A1, Holy C2, Vanderkarr M3, Sparks C4
1Johnson & Johnson, New Brunswick, NJ, USA, 2Johnson & Johnson, Somerville, MA, USA, 3DePuy Synthes, Inc., Bay Village, OH, USA, 4DePuy Synthes, West Chester, PA, USA

OBJECTIVES : Intramedullary nailing is a common treatment for proximal femoral fractures including intertrochanteric, basal neck and subtrochanteric fractures. Breakage of the nail is a rare but devastating complication. TFN-Advanced™ (TFNA), a cephalomedullary nail, is indicated to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations of the aforementioned fractures. This study evaluated the risk for nail breakage after treatment with the identified cephalomedullary nail for intertrochanteric, basal neck and subtrochanteric femur fractures in a real-world setting.

METHODS : Patients receiving treatment with TFNA (index) between 2016-2020 were identified from the Mercy Health electronic health records, which is a comprehensive longitudinal real-world database. Patients were included only if they had an intertrochanteric, basal neck or subtrochanteric femur fracture. Nail breakage was defined as ≥1 International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for breakdown of internal device and ≥1 ICD-10 procedure code for femur fracture repair or device removal from femur occurring concomitantly within the same inpatient hospitalization. Nail breakage was evaluated over two years post-index discharge.

RESULTS : A total of 733 patients with intertrochanteric, basal neck or subtrochanteric femur fractures received treatment with the cephalomedullary nail. Mean (standard deviation, SD) age was 78.4(12.6) years, 70.1% were female and 97.0% were Caucasian. 96.7% patients had an Elixhauser score >0. The top three comorbidities were hypertension (70.8%), fluid and electrolyte disorder (43.9%), and cardiac arrhythmia (40.1%). The median and the mean follow-up times post-index discharge were 170 days and 302 days, respectively. There were no cases of nail breakage identified over the two years post-treatment with the cephalomedullary nail.

CONCLUSIONS : This study found no nail breakage after treatment with the identified cephalomedullary nail for intertrochanteric, basal neck and subtrochanteric femur fractures in a real-world setting.

Conference/Value in Health Info

2020-11, ISPOR Europe 2020, Milan, Italy

Value in Health, Volume 23, Issue S2 (December 2020)

Code

PMD25

Topic

Clinical Outcomes, Medical Technologies

Topic Subcategory

Clinical Outcomes Assessment, Medical Devices

Disease

Injury and Trauma, Medical Devices, Surgery

Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×