value analysis brief - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/llnwmb8/int...

$: VALUE ANALYSIS BRIEF - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes... · • Germany – 109,341 patients experienced a hip fracture in 2002, and the annual$
VALUE ANALYSIS BRIEF

Executive Summary

Unmet clinical need:

Distal cortical impingement may occur in up to 25%

of 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 the major cause of implant failure in the fi xation

of proximal hip fractures, and may cause severe injuries in hard

and soft tissues surrounding the hip joint.7,8 Cut-out rates for

cephalomedullary nails have been reported as high as 8%, and

frequently require reoperation.7

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

patients treated with cephalomedullary nails and requires revision

surgery.11,13 Nail breakage is often a result of fractures that take longer

to heal or fail to heal (delayed union or nonunion, respectively).14

CLINICAL VALUE

1

The TFNA System was designed to address clinical challenges:

TFNA Helical Blade technology was

designed to compress bone during insertion, which enhances

implant anchorage and may reduce the risk of cut-out. Resistance

to cut-out in osteoporotic bone is further improved by cement

augmentation of the TFNA Helical Blade or screw.9,10

• A prospective, randomized clinical trial showed lower cut-out

rates in the cohort treated with a helical blade (1.5%)

compared to the screw (2.9%).11

• Biomechanical testing of off-center placement showed signifi cant

improvement in cut-out resistance for the TFNA Helical Blade

compared to both the TFNA Screw and Gamma3 Screw.12 These

results show the TFNA Helical Blade is more forgiving in regards to head element positioning.

• A clinical study with 15.3 months of follow-up showed no cut-out events for patients treated with

Helical Blade Technology and augmentation (n=62 patients).9

Off-center Position of Head Element – Mean Failure Loads (N)18

1021 ± 33 N

577 ± 41 N 612 ± 58 N

Gamma3 ScrewTFNA ScrewTFNA Helical Blade

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

TiMo titanium alloy and BUMP CUT™ Design provides the TFNA System with improved fatigue

strength when compared with existing nails of similar size.15

Results of biomechanical testing showed greater fatigue

strength for the TFNA System compared to Gamma3 and

InterTAN nails (p<0.05).15

TFNA

Gamma3

Fatigue Limit is Greater for TFNA Nails than Gamma3 and InterTAN Nails15 ‡

The TFNA System was designed with a 1.0m 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, 3-D computational study showed the TFNA nail (1.0 m ROC) resulted

in a better fi t than Gamma3 (1.5 m ROC).6

• Nail protrusion measurements are signifi cantly smaller for the TFNA Nail compared

to Gamma36

Mean total surface area Mean maximum distance in axial plane p

TFNA Nail 915.8 mm2 1.9 mm2 <0.05

Gamma3 Nail 1181.6 mm2 2.1 mm2 <0.05

• Distal Nail Tip Position:

– TFNA Nail had a higher number

of center positions than Gamma3

(13 vs. 7, respectively).6

– The far anterior position for the nail tip was observed

markedly less often with the TFNA nail compared

with the Gamma3 nail (16 vs. 30, respectively).6

*Differences are statistically signifi cant (p<0.05)

1900

1800

1700

1600

1500

1400

1300

1200

1100

1000TFNA System Gamma3* InterTAN*

24% difference 47% difference

Med

ian

Fatig

ue L

imit

(N)

1200

1000

800

600

400

200

0

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

ECONOMIC VALUE

Economic Challenge: TFNA Solution:

High Cost of Reoperation

Reduction in revision surgeries due to cut-out or other complications may result in cost

reductions for the hospital.

• A budget impact analysis was developed to show the potential economic impact to

a hospital using the TFNA System with a helical blade compared with a proximal nail

system with a screw. Results showed a hospital performing 200 proximal hip nailing

cases per year may save £23,923 annually due to the difference in cut-out rates for

helical blades versus screws.

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 hospital savings.16

• 86% of surgeons using the TFNA System "Strongly Agreed/Agreed" that they would

"Recommend this new proximal femoral nailing system"17

• The fl exibility of the TFNA System allows the surgeon to optimize 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.

Procedural Effi ciency in OR

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 "Strongly Agreed/Agreed" that "I felt the new system improved

the overall procedural effi ciency compared to previously used nailing systems"17

• 77% of surgeons "Strongly Agreed/Agreed" that "The new instrument is easier

than what I used previously"17

• In patients with severely osteoporotic bone, the use of augmentation with the helical

blade enhances implant anchorage and further reduces the risk of cut-out.9 The use

of augmentation provides additional value to the hospital when enhanced implant

anchorage is needed in patients with severe osteoporotic bone.

£60,000

£50,000

£40,000

£30,000

£20,000

£10,000

0

Screw Helical Blade

£25,632

£49,555

Ann

ual C

ost

of In

patie

nt H

ospi

tal C

are

(GBP

)

£23,923 difference

Annual Cost of Inpatient Hospital Care

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.22 The surgery is a major stress on the patient, particularly in the elderly.

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

Hip fractures are common in the elderly; The number and costs of hip fractures are expected

to rise as the population ages.18 Reducing the reoperation rate, which has been estimated

at 6.3%,19 provides an opportunity for hospitals and health care systems to save costs.20

HIP FRACTURESA hip fracture is a femoral fracture that occurs in the proximal end of the femur (the long bone running through

the thigh), near the hip. The term "hip fracture" is commonly used to refer to the fracture patterns as 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.21 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.21

FIGURE 1: Types of Hip Fracture Patterns:


EpidemiologyHip fractures are a major public health problem in terms of patient morbidity, mortality, and costs to health and

social care.23 The incidence of hip fracture increases steeply with age due to higher rates of osteoporosis and falls

in the elderly population. Hip fractures account for the majority of osteoporotic fragility fractures and for over

40% of the estimated burden of osteoporosis worldwide.23 In 2010, there were an estimated 600,000 incident

hip fractures in the European Union, and this number is expected to rise to 972,000 by 2050.23,24

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

patients.25 Most commonly, trochanteric fractures are caused by low-energy trauma events, such as falls from a

standing position, usually in combination with osteoporosis.26,27

Due to the patients’ high age and comorbidities, fractures of the proximal femur are often life threatening: in

the fi rst postoperative year, mortality rates may be as high as 30%.26,28 In young patients, trochanteric fractures

are typically associated with high-energy trauma events, such as motor vehicle, bicycle, and skiing accidents.25

Economic BurdenIn 2010, there were an estimated 600,000 incident hip fractures in the European Union, costing €20 billion and

accounting for 54% of the total costs of osteoporosis.23 These costs are expected to increase exponentially

following the growing incidence rate.24

The economic burden of treating hip fractures is substantial:

• UK – Total annual hospital costs associated with incident hip fractures were estimated at £1.1 billion in 2013.23

• Germany – 109,341 patients experienced a hip fracture in 2002, and the annual cost of care was

€2,998,000,000.29

• Portugal – Mean individual fracture-related costs were estimated at €13,434 for the fi rst year and €5985 for

the second year following the fracture. In 2011 the economic burden attributable to osteoporotic hip fractures

in Portugal could be estimated at €216 million.30

• Netherlands – The healthcare costs due to osteoporosis-related hip fractures (approximately €11,000–€13,000

per person) substantially exceeded those of other osteoporosis related fractures, such as spine, upper

extremity, lower extremity, and wrist/distal forearm.31

• Italy – A total of 85,762 hospitalizations due to hip fractures (17,597 men and 66,674 women) were recorded

in 2005 for people >65 years old.32 Hospital costs were €467 million in 2005, with rehabilitation costs reaching

€532 million in the same year.32

5

Clinical BurdenHip fractures result in pain, loss of mobility, and high rates of mortality.33 Nearly all patients are hospitalized,

and most undergo surgical repair of unstable fractures 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 fracture.34 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.33

The reoperation rate of cephalomedullary hip nailing has been estimated at approximately 6.3%.19 The most

common types of complications resulting in revision include distal cortex penetration (≤3% revision rate4,5),

proximal cut-out (≤8% revision rate7,19), and implant breakage (≤5% revision rate13). Revision surgeries are

associated with a poor prognosis, an increase in mortality, and a decrease in the number of patients able

to return to their original residence.35


METHODS

This value analysis brief presents information on the potential clinical, and economic benefi ts of using

the TFNA System. The referenced data were obtained through a systematic literature review of Ovid

Medline, Ovid Embase, and PubMed for clinical and economic studies published from 2003-2016.

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 referenced as “Data on File”.

Published results included studies reporting outcomes for proximal hip nails currently on the market

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 TFNA 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.

7

TFNA SYSTEM CLINICAL VALUE

ROC = radius of curvature

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

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 25%,1 and this complication may lead to 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).36 The distal nail design,

specifi cally 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,37-39 and clinical experiences from recent studies have shown that these ROCs may lead

to complications resulting from nail-canal mismatch.3,39,40 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.3 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

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

and Nail with 1.5 m ROC‡

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

and reduce the risk of postoperative complications.


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

with larger ROCs (i.e. straighter nails). A 3D computational study showed the 1.0m ROC of TFNA resulted in a

better fi t than the 1.5 m ROC nail (Gamma3 Long Nail R1.5, Stryker Trauma).6 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 results showed:

Nail Protrusion• Nail protrusion measurements are signifi cantly smaller for the TFNA Nail compared to Gamma3:6

ROCMean total surface

areaMean maximum distance

in axial plane p

TFNA Nail 1.0m 915.8 mm2 1.9 mm2 <0.05

Gamma3 Nail 1.5m 1181.6 mm2 2.1 mm2 <0.05

• Subgroup analyses showed mean total surface area of nail protrusion was signifi cantly smaller with the

TFNA nail compared to Gamma3 in Caucasian (p=0.0009) and Asian samples (p=0.000002).6

Distal Nail Tip Position• TFNA Nail had a higher number of center positions than Gamma3 (13 vs. 7, respectively).6

• The far anterior position for the nail tip was observed markedly less often with the TFNA nail compared

with the Gamma3 nail (16 vs. 30, respectively).6

These biomechanical results showing the improved fi t of the TFNA Nail of this study showed the TFNA Nail,

with a 1.0 ROC design, resulted in a better fi t compared with the Gamma3 nail with a 1.5m ROC design.

This could result in clinical improvements in implant fi t and potentially fewer post-operative complications.6

FIGURE 3: Distal Nail Tip Position for TFNA Compared to Gamma36‡

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

9

Case StudyApplying 3D computer modelling to an average Caucasian sample with an ROC of 1.015m resulted in a slightly

smaller misfi t in the subtrochanteric region for the TFNA Nail compared with the Gamma3 nail (Figure 4).6

Distally, the TFNA achieved a center position whereas the Gamma3 nail showed an anterior position (Figure 4).6

FIGURE 4: Case Study of Caucasian Model with an ROC of 1.015m Shows

Better Fit with TFNA Nail (1.0m ROC) vs. Gamma3 (1.5m ROC)

This 3D computational study showed the TFNA Nail with a 1.0m ROC design resulted in a better fi t compared

with the Gamma3 nail with a 1.5m ROC design as evaluated by protrusion area, protrusion distance, and far

anterior nail tip positions.6

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 the fi t of the nail. The small proximal diameter

and the LATERAL RELIEF CUT™ Design (Figure 5) of the TFNA Nail 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 Blade and Screw reduces lateral protrusion on the soft tissues when

compared with that of a standard cut head element.41

FIGURE 5: TFNA System: Designed with a Small

Proximal Diameter, Oblique Cut, and LATERAL

RELIEF CUT™

Oblique cut on the lateral end of head element

Small proximal diameter

LATERAL RELIEF CUT

TFNA: 1.0m ROC

Gamma3: 1.5m ROC


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.

Cut-out is the major cause of implant failure in dynamic hip screws, accounting for more than 80% of failures.7

PROXIMAL CUT-OUT

Defi nition 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 the extrusion, or cutting-out, of the screw or

blade element from the femoral head (Figure 6). Revision surgery is often necessary

when cut-out occurs.42

Cut-out is the most common43 cause of implant failure in the fi xation of trochanteric

fractures, accounting for more than 80% of failures in cases using dynamic hip screws.7

Cut-out rates for cephalomedullary nail devices were reported as 3.2% in a Cochrane

review of the literature,19 are often reported as high as 8%,7,43 and have also been

reported as high as 33.3%.43

A recent study published by Mingo-Robinet and colleagues (2015) evaluated the cut-out

rates of 218 fractures treated with either the Gamma Nail (Stryker) or Gamma3 Nail

(Stryker) System with lag screws.43 Cut-out rates in patients treated with Gamma3 were

4.87% for stable fractures and 33.3% for unstable fractures.43 These values for

Gamma3, a second-generation nail system, were greater than cut-out rates reported for

Gamma, a fi rst-generation nail system (p<0.05).43 The authors concluded the Gamma3

lag screw design may be the cause of the worse clinical results compared with the

Gamma Nail in unstable fractures.43

Cut-out continues to be a major complication for intramedullary hip nailing devices11

and may cause severe injuries in hard tissues as well as in soft tissues surrounding

the hip joint.8

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

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

and insertion of the standard hip screw. Figure 7 shows an image of the helical blade

and screw from the TFNA System. The helical blade is designed to be implanted without

pre-drilling, which compresses the surrounding bone7,44 resulting in an increase in

trabelcular bone density in the surrounding area (Figure 8).7 This enhances implant

anchorage45 and provides additional purchase (i.e. grip) in osteoporotic bones,7 which

may result in a decrease in the risk of cut-out. Additionally, this increase in bone

compaction minimizes the potential for rotation of the blade.7

Helical blades have shown a higher potential of rotational stability

compared with the screw-based nails.8 Furthermore, the helical

blade is associated with a statistically signifi cant 2- to 4-fold higher

torque resistance reducing rotational forces during insertion

compared with a screw system.8 Anti-rotation wires are often

required with screws to counterbalance these rotational forces.44

Use of the blade lessens the need for the anti-rotation wires, which

may add to the procedural effi ciency of the surgical technique.

FIGURE 6: Example of Cut-Out

Source: DePuy Synthes Trauma.

FIGURE 7: TFNA Screw and

TFNA Helical Blade

TFNA Helical Blade

TFNA Screw

11

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

the Gamma3 Screw in a biomechanical study conducted by the AO Foundation using

a foam model with properties that mimic osteoporotic bone.10 Head elements were

tested for fatigue strength in the foam model based on position of the head element

as either center or off-center.10 These measurements show a range of placement

options that may occur during a hip nailing procedure. Center position is the optimal

placement of the head element;46 however, placement may vary from surgeon to

surgeon resulting in off-center positioning of the head element.10

The mean failure load was calculated for each study group (TFNA Helical Blade, TFNA

Screw, and Gamma3) to determine the resistance to cut-out. Results showed failure

loads in a similar range for all head elements tested in the center position (range of

1489N to 1613N).12 For the off-center study group, the TFNA Helical Blade showed

statistically signifi cant higher resistance to cut-out compared to the TFNA Screw and

Gamma3 Screw (Figure 9).10,12 These results show that the TFNA Helical Blade is

more forgiving than a screw in terms of positioning and also shows greater resistance

to cut-out.10

In addition to the AO study evaluating the TFNA System,10 several

biomechanical studies have been published showing the improved

cut-out resistance of helical blades compared to lag screws.7,47,48

• A computational study was published by Goffi n and colleagues

(2013) evaluating the role of bone compaction with respect to

implant cut-out using a CT scan-based fi nite element model of

trochanteric fractures.7 The effect of bone compaction resulting

from the insertion of a proximal femoral nail anti-rotation (PFNA)

with a helical blade provided additional bone purchase in an

osteoporotic femoral head bone model characterized as 75% of

the initial bone density. The authors concluded that the helical

blade has the potential to decrease the number of cut-out cases

in severely osteoporotic patients.7

• A biomechanical study by Sommers and colleagues (2004)

simulated implant cut-out in an unstable pertrochanteric

fracture model.48 This model accounted for dynamic loading,

osteoporotic bone, and a defi ned implant offset. Foam models

were used to determine differences in cut-out resistance

between two lag screws (dynamic hip screw, Gamma3) and two

blade-type implant designs (dynamic helical hip system,

trochanteric fi xation nail). Results showed trochanteric fi xation

nail implants with a helical blade demonstrated the highest

cutout resistance of all implants included in the analysis.47

• A biomechanical study published by Lenich and colleagues

(2011) compared previously published experimental data of two

fi xation screws (DHS/Synthes®, Gamma3 nail/Stryker®) and

helical blades (TFN/Synthes®, PFNA/Synthes®) and compared

them to a theoretical model using loads acting in the hip during

daily activities.46 The helical blades showed greater stability

compared to the screws with regards to implant rotation in the

de-central position. This study concluded that center positioning

of the head element is the optimal position for both helical

blades and screws; however, the helical blade provides greater

stability in a de-central position compared to screws.46

FIGURE 9: Cut-Out Resistance In Vitro Modeling‡

1200

1000

800

600

400

200

0

1200

1000

800

600

400

200

0

Load

at f

ailu

re in

N

TFNA Helical Blade Shows Greater Resistance in the Off-Center Position Compared to TFNA Screw and Gamma3 Screw10

Gamma3 ScrewTFNA ScrewTFNA Blade

FIGURE 8: TFNA Helical Blade

Technology: Designed to

Compress Bone During Insertion

Screw

Helical Blade


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:

• Stern and colleagues (2011) published a prospective, randomized clinical trial of 335 pertrochanteric and

intertrochanteric fractures and compared cut-out rates of screw vs. helical blade constructs. Results showed

cut-out rates were lower in the blade group (1.5%) compared with the screw group (2.9%). All cases of

cut-out resulted in reoperation.11

• Lenich and colleagues (2010) published a single-center, case-series examining 322 patients with trochanteric

fractures treated with either third generation nails with helical blades or second generation nails with lag

screws. Results showed cut-out rates were lower in the cohort treated with helical blades (cut-out rate range

of 2.5%-7%) compared with lag screws (14% cut-out rate).48

• A multicenter case-series of 315 fractures published by Simmermacher and colleagues (2008) concluded

that nails with a helical blade limit the effects of early rotation of the head/neck-fragment in unstable

trochanteric fractures, likely preventing or at least delaying rotation-induced cut-out.49

The TFNA Helical Blade Technology provides the enhanced stability that is critical for reducing the risk of

cut-out compared to a lag screw.

13

AUGMENTATION

The TFNA System offers cement augmentation of the head element. Augmentation provides fi xation stability,

enhanced cut-out resistance, and reduced cut-through and medial migration, especially in osteoporotic bone.50

Failure of fi xation and cut-out are common problems in the treatment of osteoporotic hip fractures.51,52 Low

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

failure of fi xation postfracture.51 Achieving stable fi xation contributes to early patient mobilization and good

fracture healing.52

Augmentation of the weak bone with polymethylmethacrylate (PMMA) or calcium phosphate bone cement may

increase the stability of nail osteosynthesis, especially in unstable fractures and osteoporotic bone.9

Augmentation involved injecting the cement at the level of the neck of the femur;53 the process takes

approximately 10 to 15 minutes.50 The decision to augment may be made during surgery, allowing for full

intra-operative fl exibility for the surgeon.

Biomechanical StudiesSeveral biomechanical studies have been conducted to evaluate the performance of cement augmentation.

Sermon and colleagues (2012) conducted a study comparing PFNA blades implanted in paired femurs either

with or without cement augmentation.54 Cut-out resistance and rotational stability under cyclic loading were

evaluated. Results indicated that:

• Bone mineral density was signifi cantly related to the number of cycles to failure in non-augmented group

(P < 0.001), but not in the augmented group (P = 0.91).54

• Augmented samples showed a signifi cantly greater number of cycles to failure (P = 0.012) than

non-augmented.54

• In the groups with center position of the PFNA blade, cement augmentation led to an increase in loading

cycles of 225%. In the groups with off-center positioning of the blade, this difference was even more

substantial (933%) (see Figure 10).54

The authors concluded that augmentation with small amounts of PMMA signifi cantly enhances cut-out

resistance in proximal femoral fractures. The procedure may improve patient care, especially in

osteoporotic bone.54

FIGURE 10: Cement Augmentation Increases Cut-Out Resistance54 ‡

Augmented center

Augmented off-center

Non-Augmented center

Non-Augmented off-center

0 10,000

Cycles to 5º varus collapse

20,000 30,000PFNA = proximal femoral nail antirotation.


In a cadaveric-bone study, Fensky and colleagues (2013) compared augmented with non-augmented PFNA

fi xation.55 Cyclic testing was performed with axial loads up to 1,400 N at 10,000 cycles to simulate full

postoperative weight bearing. Results showed that stiffness after instrumentation was signifi cantly greater for

the cement-augmented group than for the non-augmented group (300.6 ± 46.7 N /mm vs. 250.3 ± 51.6 N/

mm; P = 0.001). Results indicated that the cement augmentation of PFNA may increase implant stability,

especially in osteoporotic pertrochanteric fractures.55

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).50 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. Results indicated that augmentation of the PFNA blade

prevents blade migration within the head-neck fragment, enhances implant anchorage, and leads to good

functional outcomes.50

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 2011.9,50 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 signifi cantly at follow-up, and there were no signs of osteonecrosis in the

follow-up x-rays. In addition, no blade migration was observed. Augmentation with the PFNA blade leads to

good functional results and is not associated with cartilage or bone necrosis.9 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 PFNA9,50

PFNA = proximal femoral nail antirotation.

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

15

As with PFNA, the TFNA head elements can be augmented with TRAUMACEM™ V+ bone cement. This cement

is applied through the head element around the tip of the implant with syringes and a specifi c needle kit

compatible with the TFNA HELICAL BLADE™ Technology and the TFNA Screw.41,56

The failure load of the TFNA Helical Blade and the screw were evaluated with and without augmentation in a

foam bone model that mimics human osteoporotic bone in a study conducted by the AO.10 The analysis

included samples with the head elements in the center position as well as the off-center position.10 Figure 11

shows the use of cement augmentation with the helical blade signifi cantly improves the resistance to cut-out in

both the center and off-center positions (p<0.001).10

FIGURE 11: TFNA Helical Blade with Augmentation Shows Greater Resistance

to Cut-Out in the Center and Off-Center Position in Osteoporotic Bone10

Similar fi ndings were observed for the TFNA Screw. The use of augmentation with the screw signifi cantly

improves the resistance to cut-out in both the center and off-center positions (p<0.001).10 This study shows

augmentation of the TFNA Helical Blade and Screw provides increased cut-out resistance in an osteoporotic

bone model.10

5000

4000

3000

2000

1000

0

Non-Augmented Augmented

Load

at

failu

re in

N

Off-center position

P<0.001

Center position

P<0.001


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

respectively.14 Instances of delayed unions or nonunions create excess stress on the nail57 and may 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.13 Nail breakage requires revision surgery to replace

the broken nail with a total hip arthroplasty, a hemiarthroplasty, or another hip nail.58

Resistance to Nail Breakage: Nail StrengthThe TFNA Nail was designed with specifi c features and materials to increase its fatigue strength while allowing

it to have a reduced proximal diameter without compromising strength.

The TFNA System is constructed of T-15Mo (TiMo) titanium alloy. Other commercially available hip nails are

made of either Ti-6Al-4v (TAV) ELI alloy [Gamma3 (Stryker) and InterTAN (Smith and Nephew)] or 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 TiMo is 33% higher than TAV and 28%

higher than TAN (see Figure 12).59,60 Additional testing showed TiMo is not only stronger than TAV and TAN,

but also maintains a similar level of fl exibility.61,62

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 when compared with

existing nails of similar size.15

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

1400

1200

1000

800

600

400

200

0

1400

1200

1000

800

600

400

200

0

Mpa

min

TiMo is Stronger than TAV and TAN61,62

TANTAVTIMo

The TFNA Nail offers improved fi t without compromising nail strength.

17

The strength of the TFNA System was compared to Gamma3 and InterTAN nails in a biomechanical study.15 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).15 These results show the TFNA Nail is stronger than other nail systems with similar

proximal diameters (Figure 14).

The increase in fatigue strength of the TFNA system compared to Gamma3 was also observed using fi nite

element analysis (FEA).63 These results are shown in Figure 15.

Static LockingMost cephalomedullary nails systems provide surgeons the ability

to rotationally lock the head element in position allowing for

translation of the head element but not rotation; this 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 lag screw is prevented by

friction.64 Post-operative complications, such as excessive fracture

collapse from lag screw sliding, and prominent hardware pain,

may be prevented with static locking.65

Mean slippage load of the statically locked TFNA System was

compared to statically locked Gamma3 and InterTAN constructs.65

The TFNA System showed a 47% improvement in slip load

compared to InterTAN (p<0.001) and 48% improvement

compared to Gamma3 (p<0.001).65 These results are shown in

Figure 16. The TFNA System was the only implant system able to

complete the dynamic portion of the testing without slippage of

the head element.65,66

Note: *differences compared to TFNA are statistically signifi cant (p < 0.001)

TFNA System Gamma3* InterTAN*


FIGURE 16: Static Locking: Mean Slippage Load of

TFNA is Greater than Gamma3 and InterTAN65

1000

900

800

700

600

500

400

300

200

100

0

Load

(N)

FIGURE 15: FEA Results: TFNA

Nail Shows Greater Fatigue

Strength than the Gamma3 Nail63 ‡

1750

1500

1250

1000

750

500

TFNAGamma3M

edia

n Fa

tigue

Lim

it (N

)

FIGURE 14: Fatigue Limit is Greater for TFNA

Nails than Gamma3 and InterTAN Nails15 ‡

1900

1800

1700

1600

1500

1400

1300

1200

1100

1000

TFNA System Gamma3* InterTAN*


proximal diameters of the nails

Med

ian

Fatig

ue L

imit

(N)

*Differences are statistically signifi cant (p<0.05)


ECONOMIC VALUE OF THE HELICAL BLADE TECHNOLOGY Although the overall revision rate for hip fractures is low (6.3%19), revision procedures increase the risk of

postoperative complications. The costs of hospitalization for patients who experience a complication after

hip fracture surgery are substantially higher than those for patients without complications.35 Reduction in

complications and reoperations are direct ways to reduce healthcare costs.

The TFNA System offers Helical Blade Technology to enhance stability and reduce the risk of cut-out.

Complications, such as cut-out, cut-through, and medial migration are expensive to treat and frequently

require a reoperation.35 Costs of complications and revision surgeries place a substantial economic

burden on the hospital and healthcare system.

Quantifi cation of the economic impact of complications and

revisions may be assessed using a budget impact analysis. The

analysis in Figure 17 shows the potential cost savings for a

hospital that switches from using a proximal hip nailing system

with a screw to a system with a helical blade. The following

input parameters were used:

• Stern and colleagues (2011) reported cut-out rates of 2.9%

with a screw and 1.5% with the helical blade.11

• Mean hospital costs of revision were £8,544 (converted to

€10,944) as published by Leal and colleagues (2016)23

• Annual volume was estimated at 200 cases per year.

Under these assumptions, the annual economic impact to the

hospital of revision surgeries is estimated to be of £49,555 for

cephalomedullary nail systems using a screw and £25,632 for

systems using a helical blade. Based on this model, a hospital

performing 200 hip fracture cases per year may save £23,923

annually by using a helical blade hip nailing system compared to

a hip nailing system with a screw. This potential cost reduction is

due to the difference in revision rates for helical blades versus

screws. These data show how small differences in revision rates

have the potential to make a large economic impact to the

healthcare system.

ECONOMIC VALUE OF THE TFNA SYSTEM

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

both features reduce the risk of costly reoperations due to cut-out.11,50 Reduction in reoperations

may result in substantial economic savings to the hospital system.

Budget Impact Calculations: hospital cost = annual volume x hospital cost of reoperation x reoperation rate

FIGURE 17: Potential Annual Hospital Costs

of Reoperation are Less for Helical Blades Compared

to Screws Due to Differences in Cut-Out Rate

£60,000

£50,000

£40,000

£30,000

£20,000

£10,000

0

Screw Helical Blade

£25,632

£49,555

Ann

ual C

ost

of In

patie

nt H

ospi

tal C

are

(GBP

)

£23,923 difference


19

AUGMENTATION OPTION PROVIDES ADDITIONAL VALUE IN PATIENTS WITH SEVERE OSTEOPOROTIC BONEFailures due to cut-out mainly occur in patients with severe osteoporotic bone; therefore, the cut-out rates may

be even higher than the 2.9% published by Stern et al.11 Using cement augmentation with Helical Blade

Technology has been shown to enhance implant anchorage and reduce the rate of cut-out in severely

osteoporotic patients.9,50 Cement augmentation of the blade gives the fi xation construct much more stability

due to a larger bone-implant interface.9 In a clinical study published by Kammerlander and colleagues (2014),

no complications or revisions due to cut-out were reported for patients treated with augmentation and Helical

Blade Technology (n=62 patients, average follow-up of 15.3 months).9 The use of augmentation provides

additional value to the hospital when enhanced implant anchorage is needed in patients with severe

osteoporotic bone (Figure 18).

FIGURE 18: Potential for Additional Value to the Hospital by Reducing Costs

of Reoperation Due to Reduced Rates of Cut-Out with Augmentation

Budget Impact Calculations: hospital cost = annual volume x hospital cost of reoperation x reoperation rate

This economic value analysis only focused on one post-operative complication, cut-out. The economic impact

to the hospital may be even greater when the reductions in other post-operative complications are factored into

the analysis. Reducing the risk of complications and revisions may result in opportunities for additional cost

savings and reductions in the overall economic burden to the healthcare system.

Budget Impact Calculations: hospital cost = annual volume x hospital cost of reoperation Budget Impact Calculations: hospital cost = annual volume x hospital cost of reoperation

£60,000

£50,000

£40,000

£30,000

£20,000

£10,000

0

Ann

ual C

ost

of In

patie

nt H

ospi

tal C

are

(GBP

)

Screw

£49,555

2.9% cut-out rate11

Helical Blade

£25,632

1.5% cut-out rate11

With Augmentation

0% cut-out rate9,50



FACILITATING STANDARDIZATION AND OPERATING ROOM EFFICIENCYHospitals that choose to use the TFNA System may realize indirect cost-savings opportunities from the

standardization of surgeon preference items and improving operating room effi ciency. These indirect cost

savings combined with direct cost savings from potential reduction in complications and revisions contribute

to the overall value of the TFNA System to the hospital.

Facilitating StandardizationStandardization of physician preference items is one method for enhancing a hospital’s supply chain and

driving profi tability.67 In addition to cost reduction, standardizing implants can improve effi ciency and quality

of care.68

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.16

However, surgeons often develop a strong preference for a specifi c device or manufacturer creating a

challenge for the hospital to incentivize alignment with standardization strategies that require surgeons to

change devices.69

A survey of 77 surgeons included three questions related to their clinical experience with the TFNA System:17

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

femoral nailing system”.

• 74% of surgeons “Strongly Agreed/Agreed” they “felt the new system improved the overall procedural

effi ciency compared to previously used Nailing systems”.

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

I used previously”.

These survey 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.

Procedural Effi ciency in the Operating RoomOrthopedic instruments should be intuitive to use allowing the surgeon and operating room (OR) team to focus

completely on the patient and the procedure. The instruments used with the TFNA System introduce features,

such as QUICK CLICK™ Self-Retaining Technology and radiolucent insertion handles with radiographic

indicators. These instruments were designed to streamline the procedure in the OR, potentially reduce OR time,

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

The TFNA System is optimized for hospital standardization, designed for procedural effi ciency,

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

of fracture types.

21

QUICK CLICK Self-Retaining Technology (Figure 19) was designed to ensure a fast and

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

surgical effi ciency 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

min.70 Re-sterilizations and longer surgical times lead to a greater risk of infection and

blood loss for the patient.70,71 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 20). Placement of the guide wire in the femoral

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

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

correlated with clinical success of the implant.11

FIGURE 19: TFNA System QUICK

CLICK Technology Instrumentation

FIGURE 20: TFNA System Radiolucent Insertion Handle

Flexibility of the TFNA SystemThe TFNA System offers the surgeon a wide portfolio of intramedullary nailing options

for the proximal femur. The fl exibility of the TFNA System allows the surgeon to optimize

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, and hospital administrators. 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.


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. In addition, the long nail provides three distal locking

options, including a unique oblique distal hole offset 10°,

designed to better target bone in 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 (TiMo alloy), and the

instrumentation is designed for procedural effi ciency and

improved x-ray visualization.

‡ Based on biomechanical bench testing. May not be indicative of clinical performance.

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

FIGURE 21: TFN-ADVANCED Proximal Femoral

Nailing System, Showing Both Blade and

Screw Options

The DePuy Synthes Trauma TFN-ADVANCED Proximal Femoral Nailing System is a cephalomedullary proximal

femoral nailing system (Figure 21) designed to match patient femoral anatomy, to help improve patient

outcomes, and address a wide variety of patient needs. Specifi cally, the TFNA Nail includes:

• A radius of curvature of 1.0 m

• LATERAL RELIEF CUT Design

• BUMP CUT Design

• Helical Blade Technology

• Cannulated head elements to allow for augmentation with PMMA bone cement

23

DEPUY SYNTHES TRAUMA: FOCUSED ON PATIENTS AND HOSPITALS

Trusted Quality and Innovation

• A century of breakthroughs that create value

Delivering Solutions That Help Improve Clinical Outcomes

• Industry leader in trauma

• Provide a broad, high-quality product portfolio that addresses all your trauma needs

Advanced Technical Support and Training

• Highly-trained, trauma-focused team

• Commitment to education and training

• Industry-leading, customisable education and training programs for entire OR staff


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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.

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