D E S I G N R A T I O N A L E

RADIUS OF CURVATURE

D E S I G N R A T I O N A L E

This optimized fit was determined by three anatomical studies which:1. Characterized the native femoral anatomy2. Validated the resulting fit of the nails in the distal femur

NAIL FIT VALIDATION: TFNA SYSTEM AND FEMORAL RECON NAIL

RESULTS

Less Nail Protrusion Through the Inner Cortex

The TFNA Nail had a 38% smaller mean total surface area of nail protrusion from the inner cortex surface than Gamma37*

Improved Distal Fit

• The distal nail tip was positioned in the far anterior cortex in 59% of Gamma3 samples (vs. 31% TFNA and 21% FRN)

• The FRN and TFNA nails both had a considerably higher number of center positions than the Gamma3 nail (35% and 25% vs 14%)7,8*

TFNA Nail and FRN: A Similar Fit in the Distal Femur

Despite minor differences in proximal nail shape,there was no statistical difference detected in distal nail tip position between the FRN and TFNA Nail group indicating a similar fit and resulting position in the distal femur.8*

GAMMA3† NAIL (1.5M ROC)

Distal nail tip positioned in the far anterior cortex 59% of the time8*

TFN-ADVANCED™ PROXIMAL FEMORAL NAILING SYSTEM (TFNA) & FEMORAL RECON NAIL (FRN)

Anatomic 1.0m ROC is more centralized in the canal than Gamma3, designed to address complications related to anatomical fit7,8*

Far Anterior Anterior Center Posterior Far Posterior

70%60%50%40%30%20%10%

0

21%

31%

59%

24%

38%

25%

35%

25%

14%17%

4% 2% 4% 2% 0%

Ant

erio

r Po

ster

ior

Posi

tion

(%)

FRN TFN-ADVANCED™ Proximal Femoral Nail System (TFNA) Gamma3

Despite decreases in nail radius of

curvature (ROC) over the last decades,

recent studies still report the existence

of misfit between the curve of the natural

femoral anatomy of some patients and

the curve of the nail.1 This can lead to

distal cortical impingement, which

may occur in up to 25% of hip fracture

repair cases.2-4 This complication may

lead to a fracture at the distal nail tip,

called anterior perforation, which

requires revision surgery. 2,5,6

COMPLICATIONS FROM NON- ANATOMIC FEMORAL NAIL FIT

Prior to the development of the TFNA Nail, a comprehensive

anatomical study of the femur was warranted to properly

characterize the radius of curvature of the native anatomy

and serve as the basis for a new nail design.

Based on the results of the femoral anatomy characterization, both nails were designed with a 1.0m ROC.

FEMORAL ANATOMY CHARACTERIZATION

METHODOLOGY

• 90 3D bone models were constructed from CT Data

• A computer generated software was used to create the reference geometries for the proximal anatomy and the shaft antecurvature

ETHNICITY SAMPLE SIZEAGE RANGE

(YRS)RESULTING MEAN ROC

Caucasian 47 (37 F, 10 M) 81 +/-9.1 974mm

Japanese 38 (32 F, 6 M) 71 +/- 4.7 771mm

Thai 5 (3 F, 2 M) 77 +/- 6.5 906mm

OVERALL 885mm

NAIL SYSTEM ROC

Stryker Gamma 3† & T2

1.5m, 2.0m

S&N Trigen† Intertan

1.5m, 2.0m

S&N Trigen† TAN FAN

1.5m-2.5m

Zimmer† Natural Nail†

1.27m-1.53m

STUDY SAMPLE SIZE AGE RANGE (YRS)

TFNA Nail Fit7* 63 65-103

FRN Fit8* 82 21-85

The results of the study indicated an overall ROC of 885mm, suggesting that an ROC of 1m would achieve an improved fit in the investigated population.1

D E P U Y S Y N T H E S N A I L S A R E D E S I G N E D W I T H A

1.0M ROC TO BETTER FIT PATIENT ANATOMY

METHODOLOGY

Two anatomical studies were conducted utilizing 3D computer modeling to determine fit of the nails in the distal femur.

• Both studies included samples from Caucasian and Asian decent

• The results of the FRN Fit Study were compared to the results of the previously completed TFNA Nail Fit Study

FRN PF

FRN GT

TFNA

Piriformas Fossa (PF) Entry

Greater Trochanter (GT) Entry

Gamma3

RESULTS

3D Implantation Comparison

59% of the time, the Gamma3 was FAR ANTERIOR

IN CENTRAL REGION

76%

67%

FRNTFNA IN CENTRAL REGION

41%GAMMA3

ROC 2.0m,Straighter Nail

ROC 1.5m,Bowed Nail

*Bench test results may not be indicative of clinical performance *Bench test results may not be indicative of clinical performance

1. Schmutz B, Kmiec S Jr, Wullschleger M, Altmann M, Schuetz M. 3D Computer graphical study of the femur: a basis for a new nail design. Archives of Orthopedic Trauma Surgery. 2017 Mar;137(3):321-331.

2. Roberts JW, Libet A, Wolinsky PR. Who is in danger? Impingement and penetration of the anterior cortex of the distal femur during intramedullary nailing of proximal femur fractures: preoperatively measurable risk factors. J Trauma Acute Care Surg. 2012;73(1):249-254.

3. Egol KA, Chang EY, Cvitkovic J, Kummer FJ, Koval KJ. Mismatch of current intramedullary nails with the anterior bow of the femur. Journal of Orthopedic Trauma. 2004;18(7):410-415.

4. Collinge CA, Beltran CP. Does modern nail geometry affect positioning in the distal femur of elderly patients with hip fractures? A comparison of otherwise identical intramedullary nails with a 200 versus 150cm radius of curvature. Journal of Orthopedic Trauma. 2013;27(6):299-302.

5. Parker MJ, Bowers TR, Pryor GA. Sliding hip screw versus the Targon PF nail in the treatment of trochanteric fractures of the hip: a randomized trial of 600 fractures. The Journal of Bone and Joint Surgery. British volume. 2012;94(3):391-397.

6. Miedel R, Ponzer S, Tornkvist H, Soderqvist A, Tidermark J. The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomized, controlled trial.The Journal of Bone and Joint Surgery. British volume. 2005;87(1):68-75.

7. Schmutz, B., Amarathunga J, Kmiec S, Jr., Yarlagadda P, Schuetz M. Quantification of cephalomedullary nail fit in the femur using 3D computer modelling: a comparison between 1.0 and 1.5m bow designs. Journal of orthopedic surery and research. 2016; 11(1):53.

8. DePuy Synthes Trauma. Analysis – FRN Anatomical Study. #0000271671, 2017.

† Third party trademarks used herein are trademarks of their respective owners.

Please also refer to the package insert(s) or other labeling associated with the devices identified in this brochure for additional safety information.

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Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

© DePuy Synthes 2019. All rights reserved. 108612-190301 DSUS/EM 05/19

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