Study identification

PURI

https://redirect.ema.europa.eu/resource/50577

EU PAS number

EUPAS34300

Study ID

50577

Official title and acronym

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

DARWIN EU® study

No

Study countries

United States

Study description

This is a retrospective cohort study of patients with femur fracture undergoing surgical repair with a cephalomedullary nail system in an inpatient setting. An overall cohort of patients implanted with cephalomedullary nails will be identified between January 2010 (in alignment with FDA approval date of Zimmer Natural Nail) and September 2019 or most recent data. A subset of the overall cohort implanted with TFNA, Stryker Gamma3, or Zimmer Natural Nail between February 2014 (in alignment with FDA approval date of TFNA) and September 2019 or most recent data will be identified to meet some of the objectives including the primary objective. The identified patients will be longitudinally followed for pre-specified time intervals until they experience the endpoint of interest (co-occurring diagnosis of breakdown of internal device AND procedure for femur fracture repair or device removal from femur) or a censoring event (end of hospital participation in PHD, end of risk window, end of study), whichever occurs first. Our rationale for requiring BOTH a diagnosis of breakdown of internal device AND a procedure for femur fracture repair or device removal from femur is due to the ICD-9/10 diagnosis codes for breakdown of internal device which are not specific to the cephalomedullary nails. Presence of a co-occurring procedure to repair a fractured femur or remove a device from the femur helps ensure that the device breakage refers to the device of interest. The graphic below provides a visual representation of the study design.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Anna Wallace

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Johnson & Johnson
Study protocol
Initial protocol

RWE19_SAF_013 TFNA Protocol_Final 2

English (628.04 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable