Value Analysis Brief - J&J Medical Devices · This value analysis brief presents information on the...

Value Analysis Brief

Executive Summary

Unmet need:

Distal cortical impingement may occur in up to 25%

of hip fracture repair cases and is often the result of the curve of the natural

femoral anatomy being greater than the curve of the hip nail causing a

“mismatch”.1-3 This complication may lead to a fracture at the distal nail tip,

called anterior perforation, which requires revision surgery.1,4,5

Cut-out is a major cause of implant failure in the fixation

of proximal femur fracture, and may cause severe injuries in hard

and soft tissues surrounding the hip joint.6,7

Cut-out rates for cephalomedullary nails have been reported

as high as 8%, and frequently require reoperation.6

Nail breakage may occur in as many as 5% of hip

fracture patients treated with cephalomedullary nails and requires

revision surgery.9,10

Nail breakage is often a result of fractures that take longer to heal

or fail to heal (delayed union or nonunion, respectively).11

CLINICAL VALUE

1

The TFN-ADVANCED® Proximal Femoral Nailing System (TFNA) solution:

The TFNA System was designed with a 1.0 m radius of curvature

(ROC) to reduce the risk of distal cortical impingement and anterior perforation compared

to competitive nail systems with larger ROCs. A multi-ethnic, 3D computational study

showed the TFNA Nail (1.0 m ROC) resulted in a better fit than Gamma3 (1.5 m ROC).12

• The mean total surface area of the nail protrusion was 29% less for TFNA Nail

than Gamma3 (915.8 vs. 118.6mm,2 p< 0.05).12

• The distal nail tip was positioned close to the anterior cortex for 30 Gamma3

samples compared to 16 TFNA Nail samples (difference of 53%).12

TFNA Helical Blade technology was designed to compress bone during insertion, which enhances implant anchorage

and may reduce the risk of cut-out.19 Resistance to cut-out in osteoporotic bone is further improved by augmentation of the

Head Element.16,17 The decision to use augmentation to increase the stability in unstable fractures and osteoporotic bone58 is made

intra-operatively; thereby giving surgeons multiple options for treating their patients.58

• Biomechanical testing of off-center placement showed significant improvement in cut-out resistance for the

TFNA Helical Blade compared to both the TFNA Screw and Gamma3 Screw.12 These results showed the

TFNA Helical Blade was more forgiving compared to screws in regards to head element positioning.15

• Biomechanical tests designed to evaluate cut-out resistance showed, whether the head element

is in the center or off-center position, augmented head elements withstood high loads prior

to failure.14 Additionally, augmented constructs resisted varus collapse for more cycles than

non-augmented constructs.14

• A clinical study showed lower cut-out rates in the cohort treated with a helical blade (1.5%)

compared to a screw (2.9%).13 Early results from clinical studies of PFNA (a predicate of the

TFNA System) with augmentation showed cut-out rates of 0%.16,17

Cut-out rates in the chart below were reported in three published clinical studies: Stern et al.

2011 (n=335 patients), Kammerlander et al. 2011 (n=59 patients), and Kammerlander et al. 2014

(n=62 patients).13,16,17

Implant Screw Helical Blade PFNA Head Element with augmentation

Cut-out rate 2.9%13 1.5%13 0%16,17

TFNA SYSTEM WAS SHOWN TO BE

47% STRONGER

THAN INTERTAN18TFNA SYSTEM WAS SHOWN TO BE

24% STRONGER

THAN GAMMA318

Distal Nail Tip Position is less anterior with the TFNA Nail than the Gamma3 Nail

The TFNA System is made out of a unique titanium alloy

(TiMo alloy) that allows the proximal diameter of the nail to be reduced, while

maintaining a high level of fatigue strength. This material, combined with the

BUMP CUTTM Design of the proximal hole, provides improved fatigue strength

compared with existing nails of similar size.18 Results of biomechanical testing

showed greater fatigue strength for the TFNA System compared to Gamma3

and InterTAN nails (difference of 24% and 47%, respectively; p< 0.05).18

Benchtop test results may not be indicative of clinical performance.

4500

4000

3500

3000

2500

2000

1500

1000

500

0

Load

Fai

lure

(N)

Center position

+131%

Off-center position

+244%

Non-Augmented

Augmented

TFN-ADVANCED® Proximal Femoral Nailing System Value Analysis Brief | 2

ECONOMIC VALUE

Economic Challenge: The TFNA System Solution:

High Cost of Reoperation

Reduction in reoperations

due to cut-out may reduce

costs to the hospital and

the healthcare system.

A sample budget impact

analysis was developed

to show the potential

economic impact to a

hospital. The analysis

evaluated the use of a

proximal nail system with

a screw compared to a

blade, and both head

elements compared to

augmentation using data

points from published

studies.13,16,17,71 Results

demonstrated that a

hospital with an annual

procedural volume of

200 cases per year may recognize savings of up to $270,147 when comparing augmented

to non-augmentated constructs through the reduction in reoperations due to cut-out.

Procedural Efficiency in the Operating Room

The instruments used with the TFNA System introduce design features, such as

QUICK CLICK® Self-Retaining Technology and radiolucent insertion handles with

radiographic indicators, designed to streamline the procedure in the OR, potentially reducing

OR time and minimizing pain points within the surgical procedure for OR staff and surgeons.

• 74% of surgeons (n=57 out of 77) “Strongly Agreed” or “Agreed” that “I felt the

new system improved the overall procedural efficiency compared to previously used

nailing systems”.20

• 77% of surgeons (n=59 out of 77) “Strongly Agreed” or “Agreed” that “The new

instrument is easier than what I used previously”.20

Hospital Standardization

Aligning surgeons with hospital cost reduction initiatives, such as standardization of

physician preference items, is an important step in reducing clinical supply spending and

creating opportunities for cost savings.

• 86% of early surgeon users (n=77) of the TFNA System stated they "Strongly Agreed"

or "Agreed" that they would "Recommend this new proximal femoral nailing system"20

• The flexibility of the TFNA System allows the surgeon to customize the procedure based

on patient need and surgeon preference.

For the hospital, the TFNA System offers a single hip nail system providing surgeons with the

choices they need to treat a wide variety of fracture types while promoting hospital

standardization strategies.

$300,000

$250,000

$200,000

$150,000

$100,000

$50,000

0Screw Helical Blade

Hea

lthca

re C

osts

(USD

/200

Pat

ient

s/Ye

ar)

$130,416 difference

$139,731 vs. Blade$270,147 vs. Screw

With Augmentation

Budget Impact Analysis – Annual Costs of

Reoperation May Be Less for Augmented

Constructs Compared to Non-Augmented Based

on Differences in Cut-Out13,16,17,71

Budget impact analysis assumptions: Cost of reoperation was $46,577;71 Reoperation rates due to cut-out were 2.9%13 for the screw, 1.5%13 for the blade, and 0%16,17 with augmentation; Procedure volume of 200 hip fracture cases per year.

3

BACKGROUND

Pertrochanteric, simple Pertrochanteric, multifragmentary

Intertrochanteric Subtrochanteric

Most hip fractures are treated by orthopedic surgery, which involves implanting an orthopedic device. The fracture

takes approximately 4-6 months to heal.34 The surgery is a major stress on the patient, particularly in the elderly.

Revision procedures should be avoided given the increased risk to these patients.

Hip fractures are common in the elderly, and the incidence is expected to rise as the population

ages.23 Costs of managing hip fractures in the elderly were nearly $20 billion in 2010.40

Reducing the reoperation rate, estimated at 6.3%,39 provides an opportunity for hospitals

to reduce costs.

HIP FRACTURESA hip fracture is a femoral fracture that occurs in the proximal end of the femur (thigh bone), near the hip.24 The

term “hip fracture” is commonly used to refer to the fracture patterns shown in Figure 1. In the vast majority of

cases, a hip fracture is a fragility fracture due to a fall or minor trauma in someone with weakened osteoporotic

bone.29 Hip fractures in people with normal bone are often the result of high-energy trauma such as car accidents,

falling from heights (> 10 ft.), or sports injuries.29

FIGURE 1: Types of hip fracture patterns25


EpidemiologyEach year, approximately 300,000 hip fractures occur in the United States (U.S.).30 Hip fracture rates increase

exponentially with age, with almost 90% of hip fractures occurring in people aged 65 years and older.75,76 As the

U.S. population ages, the incidence of hip fracture is expected to increase substantially. It is estimated that by 2040,

the annual incidence of hip fractures will exceed 500,000 in the U.S.77 These continuing trends will place a financial

burden on patients, families, insurers, and governments.23

• Intertrochanteric fractures constitute up to 55% of proximal femoral fractures and occur predominantly in elderly

patients.26 Most commonly, intertrochanteric fractures are caused by low-energy trauma events, such as falls from

a standing position, usually in combination with osteoporosis.40

• Due to the patients' advanced age and multiple comorbidities, fractures of the proximal femur are often life

threatening: in the first postoperative year, mortality rates may be as high as 30%.28

• In young patients, intertrochanteric fractures are typically associated with high-energy trauma events, such as

motor vehicle, bicycle, and skiing accidents.26

Economic BurdenThe economic burden of managing hip fractures in elderly individuals in the U.S. was estimated at $17-20 billion in

2010.40 A typical U.S. patient with a hip fracture spends $40,000 in the first year following hip fracture on direct

medical costs and almost $5,000 in subsequent years.40 In the U.S., hip fractures are responsible for approximately

3.5 million hospital days per year, which is more than tibial, vertebral, and pelvic fractures combined.38

Clinical BurdenHip fractures result in pain, loss of mobility, and high rates of mortality.31 Nearly all patients are hospitalized and

most undergo surgical repair of the fracture using cephalomedullary nails. Fractures of the hip are associated with

significant loss of function; one year after the fracture, fewer than 50% of patients have the same walking ability

they had prior to the hip fracture.32 Many patients lose their independence and need long-term care. Comorbidity

is an important contributory factor to hip fractures and is often a determinant of outcome.31

The reoperation rate of cephallomedullary hip nailing has been estimated at approximately 6.3%.39 The most

common complications resulting in revision include distal cortex penetration (≤ 3% revision rate),43 proximal

cut-out or lateral extrusion (≤ 8% revision rate),6 implant breakage (≤ 5% revision rate)9 or severe thigh pain.

Reoperations increase the risk to the patient and are costly to the health care system. Revision surgery is associated

with a poor prognosis, an increase in mortality, a decrease in the number of patients able to return to their original

residence, and a 2.5-times increase in the cost of treatment.37

5

METHODS

This value analysis brief presents information on the potential clinical and economic benefits of using the TFNA

System. The referenced data were obtained through a literature review of Ovid Medline, Ovid Embase, and PubMed

for clinical and economic studies published from 2003-2017.

This literature search resulted in a total of 97 publications that met the inclusion and exclusion criteria. Papers were

selected for use in this value analysis brief based on the highest level of clinical, biomechanical, and economic

evidence. Recently completed biomechanical studies were also included to support the value propositions for the

TFNA System and are referenced as “Data on File”.

Published results included studies reporting outcomes for proximal hip nails with similar features as the TFNA

System. The TFNA System builds upon the clinical heritage of existing DePuy Synthes Trauma technology:

• The TFNA Helical Blade technology is similar to the existing helical blade technology used in the Trochanteric

Fixation Nail (TFN) and Proximal Femoral Nail Antirotation (PFNA) Systems.*

• The LATERAL RELIEF CUT™ is comparable to the lateral relief cut of the Proximal Femoral Nail Antirotation-II

(PFNA-II) System.*

• The augmentation option available with the TFNA System is analogous to the cement augmentation option

available with the PFNA System.

* PFNA and PFNA II do not have 510(k) clearance and are not available for sale in the US.


TFNA SYSTEM CLINICAL VALUE

Penetration of the anterior cortex of the distal femur is a complication associated with treating proximal femoral

fractures with intramedullary devices.1 Use of long cephalomedullary nails may result in the distal tip of the nail

abutting the anterior cortex of the femur, which is called "nail impingement".1 Distal cortical impingement is

often the result of the curve of the femoral anatomy being greater than the curve of the hip nail (nail-canal

mismatch, see Figure 2).1-3 Published clinical studies have reported rates of distal cortical impingement of up to

49.6%,43 and this complication may lead to a fracture at the distal nail tip in the early post-operative period.1

This fracture event, called anterior cortex perforation, occurs in up to 3% of cases and requires revision surgery.4,5

Cephalomedullary nail designs include both short and long nails. The long nails extend to the end of the distal

femoral metaphysis (i.e. wide portion of the bone above the femoral condyles).44 The distal nail design,

specifically the radius of curvature (ROC) of a long nail, as well as the nail entry point and proximal nail

geometry are important factors for clinical success.3

Prior to the launch of the TFNA System, the ROCs for commercially available cephalomedullary nails ranged from

1.3 m to 3.0 m,45-47 and clinical experiences from recent studies have shown that these ROCs may lead to

complications resulting from nail-canal mismatch.3,47,48 Collinge and Beltran (2013) reported that femoral nails

with a ROC of 1.5 m more closely approximate the femoral bow of geriatric patients with hip fracture than nails

with a ROC of 2.0 m, and may be less likely to cause complications, such as anterior cortical abutment,

perforation, or fracture.3 This study reported rates of distal cortical impingement of 12% with a 2.0 m ROC nail

(InterTAN Nail System with 2.0m AP bow, Smith and Nephew) but only 3% with a 1.5 m ROC nail (InterTAN Nail

System with 1.5m AP bow, Smith and Nephew).3 A nail resting against the anterior femur also may be

associated with thigh or knee pain. Therefore, continuing to decrease the nail ROC to more closely match

anatomical measurements may further improve treatment outcomes.

DISTAL CORTICAL IMPINGEMENT AND ANTERIOR CORTEX PERFORATION

The TFNA System was designed to enhance anatomic fit, which may improve patient outcomes

and reduce the risk of postoperative complications.

ROC = Radius Of Curvature

Note: The gold nail represents the TFNA Nail with 1.0 m ROC. The blue nail represents a nail with 1.5 m ROC.

FIGURE 2: Curvature of the TFNA Hip Nail System (1.0 m ROC)

and nail with 1.5 m ROC

7

FIGURE 3: Distal Nail Tip Position for TFNA System Compared to Gamma312

35

30

25

20

15

10

5

0

TFNA System Gamma3

Num

ber

of b

ones

Anterior

20

13

Center

13

7

Posterior

2 1

Far posterior

1 0

Far anterior

16

30

The TFNA Nail was designed with a ROC of 1.0 m to more closely match the femoral anatomy compared to hip

nails with larger ROCs (i.e straighter nails). The TFNA Nail was evaluated in a 3D computer modeling study that

quantified whether the 1.0 m ROC provides a better anatomical fit compared with existing nail with a bow

design (Gamma3 Long Nail R1.5, Stryker Trauma).12 This study included samples derived from Caucasian (n=31),

Japanese (n=28), and Thai (n=4) subjects with a mean age of 77 years (range 65 to 103 years). The 3D computer

modeling showed:

• TFNA Nail had a significantly smaller mean total surface area of nail protrusion than the Gamma3 nail

(915.8 vs. 1181.6 mm2; p< 0.05).12

• Mean maximum distance of nail protrusion in the axial plane was significantly less for the TFNA Nail than the

Gamma3 nail (1.9 vs. 2.1 mm; p= 0.007).12

• Mean total surface area of nail protrusion was significantly smaller with the TFNA Nail compared to Gamma3

in Caucasian (p=0.0009) and Asian samples (p= 0.000002).12

The distal nail tip position was also evaluated. The distal nail tip was positioned close to the anterior cortex

for 30 Gamma3 samples compared to 16 TFNA Nail samples, a difference of 53% (Figure 3).12 Additionally,

the TFNA Nail had a considerably higher number of center positions than the Gamma3 nail (n=13 vs. 7).12

Far anteriorAnteriorCentrePosteriorFar posterior


FIGURE 4: Distal Nail Tip Position of the TFNA

Nail is Positioned Less Anteriorly than the Gamma3

Nail in a Caucasian Model with ROC 1.015 mm12

The study also showed that an average Caucasian sample with a ROC of 1.015 m resulted in a slightly smaller

mismatch in the sub-trochanteric region for the TFNA Nail compared with the Gamma3 Nail (Figure 4). Distally, the

TFNA Nail achieved a center position while the Gamma3 nail showed an anterior position.12 The results of this

study showed the TFNA Nail, with a 1.0 ROC design, resulted in a better fit compared with the Gamma3 nail with

a 1.5m ROC design. This could result in clinical improvements in implant fit and potentially fewer post-operative

complications.12

In addition to nail-canal mismatch and anterior perforation of the cortex, lateral extrusion of the nail and

impingement are also potential complications associated with nail fit. The small proximal diameter and the

LATERAL RELIEF CUT Design of the TFNA Nail (Figure 5) were designed to avoid impingement on the lateral cortex

while preserving bone in the insertion area, potentially reducing the risk of fracture displacement. Additionally,

the oblique cut on the lateral end of the TFNA Helical Blade and Screw was designed to reduce lateral protrusion

on the soft tissues when compared with that of a standard cut head element.49

FIGURE 5: TFNA System: Designed with

a Small Proximal Diameter, Oblique cut,

and LATERAL RELIEF CUT Design

TFNA System

Gamma3 Oblique cut on the lateral end of head element

Small proximal diameter

LATERAL RELIEF CUT™

Design

◀15.66 ▶ mm

◀14.12▶ mm

9

FIGURE 7: TFNA Screw and

TFNA Helical Blade

TFNA Helical Blade

TFNA Screw

TFNA Helical Blade technology is designed to compress bone during insertion, which enhances implant

anchorage and may reduce the risk of cut-out, a serious post-operative complication often resulting in

reoperation. The use of augmentation is an option for providing additional cut-out resistance, when needed,

in patients with poor bone quality. Cut-out is a major cause of implant failure in dynamic hip screws,

accounting for more than 80% of failures.60,78

PROXIMAL CUT-OUT

Definition of Cut-OutImplant cut-out is a loss of implant anchorage in the bone that causes the femoral neck-shaft

angle to collapse, leading to extrusion, or cutting-out, of the screw or blade element from

the femoral head (Figure 6). Revision surgery is frequently necessary when cut-out occurs.16

Cut-out is the major cause of implant failure in the fixation of proximal femur fractures,

accounting for more than 80% of failures in cases using dynamic hip screws.60,78 Cut-out

rates for cephalomedullary nail devices were reported at 3.2% in a Cochrane review of the

literature,39 and have also been reported as high as 8%.6 Cut-out continues to be a major

complication for intramedullary hip nailing devices13 and may cause severe injuries in hard

tissues as well as in soft tissues surrounding the hip joint.7 The TFNA System has

incorporated two features that were designed to reduce the risk of cut-out: the helical

blade and augmentation.

Advantages of Helical BladesHelical blade devices offer an advantage in fracture repair because they allow for bone

compaction around the head element and avoid the bone loss that occurs with the drilling

and insertion of the standard hip screw. Figure 7 shows the TFNA Helical Blade and Screw.

The helical blade is designed to be implanted without pre-drilling, which displaces the

bone in the voids of the surrounding cancellous bone material (Figure 8). The bone

compression that results from inserting a helical blade50 increases trabecular bone density

in the surrounding area.60 This enhances implant anchorage and provides additional

purchase (i.e., a firm grip) in osteoporotic bones, which may result in a decreased risk of

cut-out.50 Additionally, this increase in bone compaction may minimize the potential for

rotation of the blade.

Helical blades have shown a higher potential for rotational stability compared with

screw-based nails.7 Furthermore, the helical blade is associated with a statistically

significant 2- to 4-fold higher torque resistance reducing rotational forces during

insertion compared with a screw system.7 Anti-rotation

wires are often required with screws to

counterbalance these forces.51 Use of the blade

lessens the need for anti-rotation wires, which

may add to the procedural efficiency of the

surgical technique.

FIGURE 6: Example of Cut-Out


The resistance to cut-out of the TFNA Helical Blade was compared to the TFNA Screw and

the Gamma3 Screw in a biomechanical study using a foam model with properties that

mimic osteoporotic bone.19 Head elements were tested for fatigue strength in the foam

model based on the position of the head element (either center or anterior off-center).19

These measurements showed the range of placement options that may occur during a hip

nailing procedure. Center position is the optimal placement of the head element;53

however, actual placement may vary from surgeon to surgeon resulting in off-center

positioning of the head element.19 The mean failure load was calculated for each study

group (TFNA Helical Blade, TFNA Screw, and Gamma3) to determine the resistance to

cut-out.19 Results showed failure loads in a similar range for all head elements included in

the analysis for the center position (range of 1489N to 1613N).19 For the off-center study

group, the TFNA Helical Blade is more forgiving than the TFNA Screw and Gamma3 Screw

in terms of positioning and also shows greater resistance to cut-out.19

In addition to the study evaluating the TFNA System,19 several biomechanical studies have

also been published showing the improved cut-out resistance of helical blades compared

to lag screws.52,53,60 The improved cut-out resistance of helical blades compared to lag

screws has also been studied clinically. The following clinical studies report the cut-out rates

of helical blades compared to screws:

• A prospective, randomized clinical trial of 335 pertrochanteric and intertrochanteric

fractures reported lower cut-out rates in the blade group (1.5%) compared with the

screw group (2.9%). All cases of cut-out resulted in reoperation.13

• A multicenter, case-series of 315 fractures concluded that nails with a helical blade limit

the effects of early rotation of the head/neck fragment in unstable trochanteric fractures;

likely preventing rotation-induced cut-out.54

• In a single-center, case-series study of 322 patients with

proximal femur fractures, cut-out rates were lower with

third-generation nails with helical blades (cut-out rate 2.5%-

7.0%) than with second-generation nails with lag screws

(14% cut-out rate).55

Mingo-Robinet and colleagues (2015) evaluated the relationship

between the type of intramedullary device and the presence of

cut-out complications.56 The Trochanteric Gamma Nail (Stryker)

and Gamma3 Nail (Stryker), both using lag screws, were

included in the analysis of 218 fractures. Results show cut-out

rates of up to 3.9% in patients with undisplaced fractures

treated with Gamma Nail and up to 33.3% in patients treated

with Gamma3.56 The authors noted that unstable fracture was

one of the most important risk factors for fixation failure.56

The TFNA Helical Blade Technology provides the enhanced

stability that is critical for reducing the risk of cut-out compared

to a lag screw.

FIGURE 8: TFNA Helical Blade

technology: Designed to

Compress Bone During Insertion

Note: Cross-sections of bone illustrating TFNA Helical Blade (left) and TFNA Screw (right)

TFNA Screw

TFNA Helical Blade

FIGURE 9: Cut-Out Resistance in vitro Modeling

Load

at

failu

re in

N

TFNA Helical Blade Shows Greater Resistance in the Off-Center Position Compared to TFNA Screw and Gamma3 Screw19

Gamma3 ScrewTFNA ScrewTFNA Helical Blade

1600

1200

800

400

0

11

Advantages of AugmentationFailure of fixation and cut-out are common problems in the treatment of osteoporotic hip fractures.57,58 Low

bone mineral density and thin cortices not only are major risk factors for hip fractures but also contribute to

the failure of fixation postfracture.57 Achieving stable fixation contributes to early patient mobilization and

good fracture healing.58

Augmentation of poor quality bone with polymethylmethacrylate (PMMA) or calcium phosphate bone cement

may increase the stability of nail osteosynthesis, especially in osteoporotic bone.17 Augmentation involves

injecting the cement into the femoral head; the process takes approximately 10 to 15 minutes.16 The decision

to augment may be made during surgery, allowing for full intra-operative flexibility for the surgeon.

TFNA Helical Blades and Screws may be augmented with TRAUMACEM™ V+ Injectable Bone Cement. This

cement is inserted through the head element with a syringe and a specific needle kit compatible with the

TFNA Helical Blades and Screws (Figure 10).61 The cannulation of the implant, and additional fenestrations in

the TFNA Helical Blades and Screws, enable the controlled injection of cement into the surrounding bone

tissue after implant insertion.

The TFNA System offers cement augmentation of the head element. Augmentation provides

fixation stability and resistance to cut-out, cut through and unexpected blade migration, especially

in osteoporotic bone.16 The decision to augment may be made during surgery, providing surgeons

with flexible intra-operative solutions for their patients.

Source: DePuy Synthes Trauma.

FIGURE 10: TFNA Helical Blade with Augmentation


Biomechanical StudiesBiomechanical studies have been conducted to evaluate the performance of the TFNA System with augmentation.

The failure load (which is the maximum amount of force that can be applied to the nail construct in a

biomechanical simulation, after which the cut-out event occurs) of the TFNA Head Element was evaluated for

constructs with and without augmentation. The study included samples with the head elements in the center

position as well as the off-center position.14 While center position is the optimal placement of the head element,14

placement may vary from surgeon to surgeon resulting in off-center positioning.53 This study used an artificial bone

material that mimics human osteoporotic bone in the femoral head.14 Results demonstrated a significant

(p= 0.000) increase in failure load (simulated decrease in cut-out) when the TFNA Head Element is augmented.

The increased failure load exceeded 131% compared with non-augmented constructs in the center position. The

greatest improvement in failure load (simulated cut-out event) was observed for the TFNA Construct in the

off-center position, which improved by 244%.14 Furthermore, augmented constructs resisted varus collapse for

more cycles than non-augmented constructs both in the center (+271%) and off-center (+346%) positions.14 This

study demonstrated that augmentation of the TFNA Helical Blade and Screw allowed the constructs to withstand

higher loads for more cycles, which may correlate with increased cut-out resistance in osteoporotic bone.

4500

4000

3500

3000

2500

2000

1500

1000

500

0

Non-Augmented Augmented

Load

Fai

lure

(N)

Off-center positionCenter position

+131%

+244%

FIGURE 11A: Augmented Head Elements Withstood Higher Loads

Prior to Failure14

3500

3000

2500

2000

1500

1000

500

0

Non-Augmented Augmented

Cyc

les

to 5

° Va

rus

Col

laps

e

Off-center positionCenter position

+271%

+346%

FIGURE 11B: Augmented Constructs Resisted Varus Collapse for More

Cycles Than Non-Augmented Constructs14


13

Clinical Studies Kammerlander and colleagues (2011) reported the results of a prospective, multi-center study to evaluate the

technical performance and early clinical results of augmentation of the PFNA blade with PMMA bone cement

(mean volume 4.2 mL).16 A total of 59 patients with osteoporosis were included in the study (mean age 84.5

years); mean follow-up was 4 months. Results showed 55.3% of the patients reached the same or better mobility

than before the fracture. No events of cut-out, cut-through, unexpected blade migration, implant loosening, or

implant breakage were observed. The overall surgical complication rate was 3.4%; however, no complications

were related to the cement augmentation. These early clinical results show augmentation of the PFNA blade

resulted in no cut-out, cut through, unexpected blade migration, implant loosening or implant breakage, and led

to good functional results within the study period.16

Kammerlander and colleagues (2014) reported long-term results (mean follow-up 15.3 months) from an enlarged

population of the same patient group from the study published in 2011.16,17 In the 62 patients included in the

analysis, 59.6% of patients reached their pre-fracture mobility level within the follow-up time frame. The overall

surgical complication rate was 3.2%, with no complications related to the cement augmentation. The mean hip

joint space did not change significantly at follow-up, and there were no signs of osteonecrosis in the follow-up

x-rays. In addition, no unexpected blade migration was observed. Augmentation with the PFNA blade led to good

functional results and was not associated with cartilage or bone necrosis.17 Table 1 presents a side by side

comparison of the results from the two analyses of this patient group.

TABLE 1: Side-by-Side Comparison of Short-Term and Long-Term Results

of Cement Augmentation of the PFNA16,17

Clinical Outcome Kammerlander et al., 2011 (N = 59) Kammerlander et al., 2014 (N = 62)

Mean follow-up 4 months 15.3 months

Mean volume of cement injected 4.2 mL 3.8 mL

Percentage of patients reaching their pre-fracture mobility level

55.3% 59.6%

Overall surgical complication rate 3.4% 3.2%

Complications related to cement augmentation

None None

Cut-out rate 0% 0%


IMPLANT STRENGTHDelayed unions or nonunions are defined as broken bones that take longer than usual to heal or fail to heal,

respectively.11 Instances of delayed unions or nonunions create excess stress on the nail.62 Excess stress can cause

nail failure, which frequently occurs at the proximal hole of the nail. Nail breakage may occur in as many as 5%

of hip fracture patients treated with cephalomedullary nails.9 Nail breakage requires revision surgery to replace

the broken nail with a total hip arthroplasty, a hemiarthroplasty, or another hip nail.10

Resistance to Nail Breakage: Nail StrengthThe TFNA Nail was designed with specific features and materials allowing it to have a reduced proximal diameter

without compromising strength.

The TFNA System is constructed of T-15Mo (TiMo) titanium alloy. Gamma3 (Stryker) and InterTAN (Smith and

Nephew) are both made of Ti-6Al-4v (TAV) ELI alloy while other commercially available hip nails are made of

Ti-6Al-7Nb (TAN). TiMo was chosen as the alloy for the TFNA System because of its combination of high

strength and fatigue resistance. TiMo is a biocompatible titanium alloy that meets the requirements of ASTM F

2066 testing protocol. When heat-treated, the minimum mechanical strength of Ti15Mo is 33% higher than

TAV and 28% higher than TAN (see Figure 12).63,64 Additional testing showed that Ti-15Mo is not only stronger,

but it is also as flexible as TAV and TAN.65,66

The increased strength in combination with the BUMP CUT™ Design of the proximal hole (Figure 13), and other

design improvements in the TFNA System provides improved fatigue strength in benchtop testing when

compared with existing nails of similar size.18

The TFNA Nail offers improved fit without compromising nail strength.

FIGURE 13: TFNA System BUMP CUT Design FIGURE 12: TFNA System Material Strength

1400

1200

1000

800

600

400

200

0

Mpa

TiMo is Stronger than TAV and TAN

TANTAVTIMo


15

FIGURE 14: Fatigue Limit Was Greater for TFNA

Nails than Gamma3 and InterTAN Nails18

1900

1800

1700

1600

1500

1400

1300

1200

1100

1000

TFNA System Gamma3 InterTAN

24% difference* 47% difference*

Proximal diameters of the nails

FIGURE 15: TFNA Nail Showed

Greater Fatigue Strength than

the Gamma3 Nail67

1750

1500

1250

1000

750

500

TFNA System Gamma3


Physical fatigue load testing was conducted to compare the strength of the TFNA System to Gamma3 (Stryker) and

InterTAN (Smith and Nephew).18 The median fatigue limit for the TFNA Nails was 24% greater than the Gamma3

nail (p< 0.05) and 47% greater than the InterTAN nail (p< 0.05) (Figure 14), differences that were statistically

significant.18 These results showed the increased strength of the TFNA Nail compared to other nail systems with

similar proximal diameters (Figure 14).

An increase in fatigue strength of the TFNA System compared to Gamma3 was also observed using finite element

analysis (FEA).67 These results are shown in Figure 15.

Med

ian

Fatig

ue L

imit

(N)

Med

ian

Fatig

ue L

imit

(N)

* Differences compared to the TFNA System were statistically significant (p< 0.05)


Static LockingMost cephalomedullary nail systems provide surgeons the ability to rotationally lock the head element in position

allowing for translation of the head element but not rotation, which is commonly referred to as guided collapse.

The TFNA System provides surgeons with the option to statically lock the head element thus preventing both

rotation and translation. Static locking involves fully tightening the set screw onto the head element so that linear

movement of the head element is prevented by friction.68 Post-operative complications, such as excessive fracture

collapse from head element sliding and prominent hardware pain, may be prevented with static locking.69

The mean slippage load of the statically locked TFNA System was compared to statically locked Gamma3 and

InterTAN constructs.70 The TFNA System showed a 48% improvement in slip load compared to Gamma3

(p< 0.001) and 47% improvement in slip load compared to InterTAN (p< 0.001).70 These results are shown in

Figure 16. The TFNA System was the only implant system to complete the dynamic portion of the testing

without slippage of the head element.69

FIGURE 16: Static Locking: Mean Slippage Load of the TFNA System

Was Greater than Gamma3 and InterTAN70

TFNA System Gamma3 InterTAN

48% difference* 47% difference*

1000

900

800

700

600

500

400

300

200

100

0

Med

ian

Fatig

ue L

imit

(N)

* Differences compared to the TFNA System were statistically significant (p< 0.001)


17

HIP FRACTURES: HOSPITAL INPATIENT STATISTICS Table 2 shows 2014 Centers for Medicare and Medicaid Services national statistics for Medicare Severity

Diagnosis-Related Groups (MS-DRGs) related to treating hip fractures with cephalomedullary nails.8

Both primary hip nailing procedures and revisions fall under MS-DRGs 480, 481, or 482, depending on

severity of complications and comorbidities.

TABLE 2: National Statistics from the Centers for Medicare and Medicaid Services (CMS)8

cc= complications and comorbidities; mcc = major complications and comorbidities; w/ = with; w/o = without

Note: DRGs 480/481/482 include treatment of hip fractures with intramedullary devices and plates. Total hip arthroplasty and hemi-arthroplasty procedures are covered under separate DRG categories. Hospital costs and charges for inpatient procedures are publicly available from CMS as reported in the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS).

TFNA SYSTEM ECONOMIC VALUE

The TFNA System includes Helical Blade Technology and the option for cement augmentation;

and both features may reduce the risk of cut-out.16,17 Reduction in cut-out and subsequent reduction

in reoperations may result in substantial economic savings to the hospital system.

Total Number of Discharges per DRG

% of Patients on Medicare

Length of Stay (Mean)

Hospital Charges (Mean)

Hospital Costs (Mean)

MS-DRG 2014

480 Hip & femur procedures except major joint w/ mcc

44,805 78.4% 8.1 $88,715 $23,324

481 Hip & femur procedures except major joint w/ cc

139,140 77.8% 5.1 $59,481 $15,877

482 Hip & femur procedures except major joint w/o cc/mcc

66,785 52.5% 3.7 $48,924 $13,191

Weighted Average 5.3 $61,893 $16,492


Hip Fractures: 90-day Costs of Reoperation The TFNA System was designed to reduce costly reoperations resulting from cut-out. To understand the full

economic impact of a reoperation, the healthcare costs of hip fracture reoperations were evaluated for both the

acute-care setting as well as during the 90-day post-operative period, as many post-operative services are part of

the hospital network. A retrospective claims database analysis was published by Lerner and colleagues (2016) to

determine the cost of reoperation associated with cephalomedullary fixation in patients aged 65+.71 Direct medical

resource utilization (claims payments) across multiple settings of care were explored for the 90-day period after

index hospitalization.71 Costs of hospitalization as a result of reoperation were reported as being $14,785 (referred

to as “Index Hospitalization” in Table 3) and total cost of reoperation, inclusive of the 90-day post-operative

period, were demonstrated to be $46,577 (Table 3). Table 3 also reports days of service for each post-acute care

setting. The average hospital length of stay for these patients was 5.3 days. The highest cost for post-acute care

service was time spent in a skilled nursing facility. Patients stayed in this setting of care for an average of 37 days

for a cost of $12,002. Costs associated with the physician, inpatient rehabilitation, home health care, and

additional inpatient readmissions were also substantial.

TABLE 3: Total 90-Day Costs of Reoperation Associated with Cephalomedullary Fixation

in Patients Aged 65+

Mean Cost of Reoperation

Days of Service Payment Amounts (USD)

Setting of Care Mean SD Mean SD

Index hospitalization 5.3 2.8 $14,785 $4,542

Physician -- -- $5,159 $3,925

Durable Medical Equipment -- -- $203 $536

Home Health Agency 15.6 25.0 $2,936 $3,802

Skilled Nursing Facility 37.0 28.7 $12,002 $11,656

Inpatient Rehab Facility 2.2 7.2 $4,206 $11,904

Other inpatient admissions 3.1 5.8 $6,960 $15,127

Hospice 3.5 15.6 $326 $1,365

Total -- -- $46,577 $26,607

USD = US Dollars; SD= Standard Deviation

The cost of reoperation shown in Table 3 is the average cost per episode. For a hospital treating multiple hip

fracture patients per year, the economic impact of treating reoperations may become quite significant.

Technologies designed to reduce costly reoperations, such as the TFNA System, should be considered in support

of Institute for Healthcare Improvement (IHI) Triple Aim strategies.

19

ECONOMIC VALUE OF THE TFNA SYSTEM Reduction in reoperations due to cut-out or other complications may reduce the overall economic burden of

treating hip fractures and are direct ways to reduce costs to the hospital as well as to the health care system.

Complications following hip fracture, such as infection, implant removal, fracture, and fixation failure are costly.37

Quantification of the economic impact of complications and revisions may be assessed using a sample budget

impact analysis with input parameters based on published data sources and annual volume assumptions. The

sample analysis below shows the potential economic impact to a hospital using a proximal hip nailing system with

a helical blade compared to a screw. The following input parameters were used and included cut-out rates

reported in three published clinical studies: Stern et al. 2011 (evaluating screw vs. blade; 335 patients),

Kammerlander et al. 2011 (evaluating PFNA with augmentation; 59 patients), and Kammerlander et al. 2014

(evaluating PFNA with augmentation; 62 patients):

Lag Screw Helical Blade Augmented Construct

Reoperation Rates Due to Cut-Out 2.9%13 1.5%13 0%16,17

Mean 90-Day Direct Costs of Reoperation71 $46,577 $46,577 $46,577

Annual Hospital Volume* 200 200 200

*Hospital volume assumption is representative of a mid-volume hospital.

Note: Sample Calculation = volume x cost of reoperation x reoperation rate due to cut-out:

TFNA Screw: 200 cases x $46,577 x 2.9% = $270,146.60

TFNA Helical Blade: 200 x $46,577 x 1.5% = $139,731

FIGURE 17: Annual Hospital Costs of Reoperation

May Be Less for Augmented Constructs Compared to

Non-Augmented Based on Differences in Cut-Out Rate

$300,000

$250,000

$200,000

$150,000

$100,000

$50,000

0

Lag Screw Helical Blade

Hea

lthca

re C

osts

(USD

/200

Pat

ient

s/Ye

ar)

$130,416 difference

$139,731 vs. Blade$270,147 vs. Screw

With Augmentation

Under these assumptions, the potential annual economic

impact of reoperations due to cut-out is shown in Figure 17:

• $270,147 for a hospital using the TFNA System with

augmentation compared to using the TFNA Screw

without augmentation.

• $139,731 for a hospital using the TFNA System with

augmentation compared to using the TFNA Helical Blade

without augmentation.

• $130,416 for a hospital using the TFNA Helical Blade

compared to the TFNA Screw, both without augmentation.

This economic analysis focused only on one postoperative

complication, cut-out. The economic impact to the hospital

may be even greater when the reductions in other

postoperative complication rates are factored into the analysis.

Reducing the risk of complications and rehospitalizations may

result in opportunities for cost savings and reductions in the

overall economic burden on the healthcare system.


FACILITATING OPERATING ROOM EFFICIENCY AND HOSPITAL STANDARDIZATIONIn addition to reduction in reoperation, further opportunities for cost offsets with the TFNA

System include the standardization of surgeon preference items and improved operating

room efficiency.

Procedural Efficiency in the Operating Room

Orthopedic instruments should be intuitive to use to allow the surgeon and operating

room (OR) team to focus completely on the patient and the procedure. The instruments

used with the TFNA System introduce design features, such as QUICK CLICK Self-Retaining

Technology and radiolucent insertion handles with radiographic indicators that were

designed to streamline the procedure in the OR, potentially reducing OR time and

minimizing pain points within the surgical procedure for OR staff and surgeons.

QUICK CLICK Self-Retaining Technology (Figure 18) is designed to ensure a fast and

effective link between the insertion handle and intramedullary nail, potentially improving

surgical efficiency and reducing OR time. A mishandled instrument or implant may result

in the need for immediate-use steam sterilization or traditional steam sterilization,

respectively. Unexpected sterilization may delay the surgical procedure as much as 30

minutes.72,73 Re-sterilizations and longer surgical times lead to a greater risk of infection and

blood loss for the patient.41,42,72,74 For hospitals, longer procedure times and re-sterilizations

result in increased costs in addition to the risk of infection and readmissions.

Radiolucent insertion handles with radiographic indicators allow x-ray visualization and

assist with guide wire placement (Figure 19). Placement of the guide wire in the femoral

head is a critical step in a hip-nailing procedure. Guide wire position dictates final

placement of the femoral head element. Studies have shown that proper positioning is

correlated with clinical success of the implant.13

The TFNA System is designed for procedural efficiency, optimized for hospital standardization,

and offers a wide array of options to address surgeon preference for treating a full range

of fracture types.

FIGURE 18: TFNA System

QUICK CLICK Technology

Instrumentation

FIGURE 19: TFNA System Radiolucent Insertion Handle

21

Facilitating StandardizationThe standardization of physician preference items is one way to enhance a hospital’s supply chain and drive

profitability.36 Two recent case studies examining the standardization of orthopedic physician preference items

show an 8% savings in a single Florida hospital ($400,000) and 32% savings in a Midwest 3-hospital system

($1.9M).27,35 In addition to cost reduction, standardizing implants may improve efficiency and quality of care.33

Aligning surgeons with hospital cost reduction initiatives, such as standardization of physician preference items,

is an important step in reducing clinical supply spending and creating opportunities for substantial savings.21

However, surgeons often develop a strong preference for a specific device or manufacturer, creating a challenge

for the hospital to incentivize alignment with standardization strategies that require surgeons to change devices.22

In a survey of 77 early users of the TFNA System, the surgeons were asked three questions related to their clinical

experience with the product:20

• 86% of surgeons stated they “Strongly Agreed” or “Agreed” that they “would recommend this new proximal

femoral nailing system”.

• 74% of surgeons “Strongly Agreed” or “Agreed” that “I felt the new system improved overall procedural

efficiency compared to previously used nailing systems.”.

• 77% of surgeons “Strongly Agreed” or “Agreed” that “The new instrumentation is easier than what

I used previously.”.

These results indicate a high level of surgeon satisfaction with the TFNA System. The strong willingness to

recommend the TFNA System is a good indicator of potential surgeon alignment in support of hospital

standardization strategies.

Flexibility of the TFNA SystemThe TFNA System offers the surgeon a wide portfolio of intramedullary nailing options for the proximal femur.

The flexibility of the TFNA System allows the surgeon to customize the procedure based on patient need and

surgeon preference. For the hospital, the TFNA System offers a single hip nail system providing surgeons with the

choices they need to treat a wide variety of fracture types while promoting hospital standardization strategies.

SUMMARYThe TFNA System was designed to solve a wide range of unmet needs for surgeons, OR staff, hospital

administrators, and patients. This system offers advancement in hip fracture treatment, including outcome-

based design, reduced procedural complexity, and comprehensive surgical options. The TFNA System was

developed to deliver clinical and economic value to patients, surgeons, and hospitals through improved

outcomes and cost savings opportunities.


TFNA SYSTEM PRODUCT DESCRIPTION

To suit a wide variety of clinical needs and surgeon preferences,

the system includes an array of options, including both short and

long nails and the option for augmentation. Further, it is the only

system to offer both helical blade and screw options using one

nail and the intra-operative option of augmentation. In addition,

the long nail provides three distal locking options, including a

unique oblique distal hole offset 10º, designed to better target

bone condyles.

The TFNA System also offers a preassembled locking mechanism

in the nail with the ability to both rotationally and statically lock

the helical blade or screw. All nails in the TFNA System are made

from a high-strength titanium alloy (Ti-Mo Alloy), and the

instrumentation is designed for procedural efficiency and

improved x-ray visualization.

For a complete list of indications for use, warnings, and precautions, please see the package insert or surgical technique.

FIGURE 20: TFNA System Showing Both Blade

and Screw Options

The DePuy Synthes Trauma TFNA System is a cephalomedullary proximal femoral nailing system (Figure 20)

designed to match patient femoral anatomy, help improve patient outcomes, and address a wide variety

of patient needs. Specifically, the TFNA System includes:

• A radius of curvature of 1.0 m

• LATERAL RELIEF CUT Design

• BUMP CUT Design

• Helical Blade Technology

• Fenestrated head elements to allow for use with TRAUMACEM V+ Augmentation System

23

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and penetration of the anterior cortex of the distal femur during

intramedullary nailing of proximal femur fractures: preoperatively

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249-254.

2. Egol KA, Chang EY, Cvitkovic J, Kummer FJ, Koval KJ. Mismatch of

current intramedullary nails with the anterior bow of the femur. Journal

of orthopaedic trauma. 2004;18(7):410-415

3. 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 150 cm

radius of curvature. Journal of orthopaedic trauma. 2013;27(6):

299-302.

4. Parker MJ, Bowers TR, Pryor GA. Sliding hip screw versus the Targon PF

nail in the treatment of trochanteric fractures of the hip: a randomised

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volume. 2012;94(3):391-397.

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Gamma nail or the Medoff sliding plate for unstable trochanteric and

subtrochanteric fractures. A randomised, controlled trial. The Journal of

Bone and Joint Surgery. British volume. 2005;87(1):68-75.

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fractures. Diagn Pathol. 2014 Oct 1; 9:191.

7. Al-Munajjed AA, Hammer J, Mayr E, Nerlich M, Lenich A.

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14. DePuy Synthes Test Data on File. Windchill 0000268245.

15. TFNA Clinical Evidence Generation Performance of TFNA Head Element

In: Scherrer S, ed2015.

16. Kammerlander C, Gebhard F, Meier C, Lenich A, et al. Standardised

cement augmentation of the PFNA using a perforated blade: a new

technique and preliminary clinical results. A prospective multicentre

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19. Hofmann L, Zderic I, Hagen J, Agarwal Y, Scherrer S, Weber A, Altmann

M, Windolf M, Gueorguiev B. Biomechanical effect of bone cement

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