bone&jointoutcome vol 04, no 01 july 2017 · zehir, 2015 • • • zhang, 2013 • • •...

The TRIGEN™ INTERTAN™ Intertrochanteric Antegrade NailA Systematic Literature Review and Meta-analysis of Clinical Outcomes Compared to Standard of Care in the Treatment of Intertrochanteric Hip Fractures

Bone&JointOutcome Our Products in Clinical Studies

Vol 04, No 01 July 2017

Page – 2Bone&JointOutcome Vol 04 – No 01 – July 2017

TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nail: A Systematic Literature Review and Meta-analysis

Authors:

Leo Nherera¹, Catherine Dunbar², Jonathan Ridgway¹, Alan Horner¹

1 Smith & Nephew, Hull, UK2 Smith & Nephew, Baar, Switzerland

REF

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END

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Overview 3

Background 4

Methods 5

Results 7

Conclusions 13

Review 14

Appendix 15

References 17

Table of Contents



The TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nail: A Systematic Literature Review and Meta-analysis of Clinical Outcomes Compared to Standard of Care in the Treatment of Intertrochanteric Hip Fractures

Purpose of reviewTo evaluate and summarize the current evidence on the clinical performance of the TRIGEN INTERTAN (Smith & Nephew, Memphis, TN, USA) integrated two-screw cephalomedullary nail compared to other devices used as standard of care in the treatment of intertrochanteric hip fractures. Standard care for intertrochanteric fractures is either the use of extrameduallary implants such as a sliding hip screw or an intramedullary nail, depending upon the fracture sub-type 1.

BackgroundSince its introduction in 2006, several studies have reported on the performance of TRIGEN INTERTAN nail. To obtain a more thorough understanding of this device’s performance, we conducted a systematic review of the literature to collect data from comparative studies reporting: implant-related failures; non-union rates; revision or reoperation rates; and/or patient functional status measures.

Key results and considerationsA systematic literature review and meta-analysis of the literature found that, compared to those treated with comparator devices the TRIGEN INTERTAN nail results in:

• A 69% reduction in implant failures (p=0.001)• A 73% reduction in non-unions (p=0.01)• A 54% reduction in patients complaining of hip and thigh pain (p=0.003)• Improvement in health related quality of life, as measured by the SF-36 (physical health) score, in a single study (p=0.002)

Appendix: An additional analysisIn addition to the systematic literature review and meta-analysis, a review of time to union data in further publications found:

• A faster time to fracture union with the TRIGEN INTERTAN nail: 14.1 weeks vs 16.9 weeks for comparator devices (see appendix)

Study characteristics

Number of studies: 10

Mean follow-up: 15.3 months

Mean age: • TRIGEN INTERTAN = 78.3 • Comparators = 77.8 yearsMean sample size: • TRIGEN INTERTAN = 95• Comparators = 104

Number of hips in study: 1,994

Study designs included:• RCTs;• Retrospective comparative

OV

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Type of evidence

Design rationaleClinical study

Economic analysis

Literature review

Pre-clinical study

Registry data

Evidence

Level of evidence rating

IV

III

II

I

4

6

Number of clinical studies (Total = 10)

Leve

l of e

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nce

Overview



Background

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Since its introduction in 2006, several studies have reported on the performance of the TRIGEN™ INTERTAN™ nail (Figure 1). To obtain a more thorough understanding of this device’s performance, we conducted a systematic review of the literature to collect data from comparative studies reporting: implant-related failures; non-union rates; revision or reoperation rates; and/or patient functional status measures.

Figure 1: TRIGEN INTERTAN



A comprehensive systematic literature review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines2.

Eligibility criteriaThe eligibility criteria for the systematic literature review are outlined below.

Inclusion criteria: 1. Full-text peer-reviewed articles reporting the outcomes of clinical studies 2. Articles in English 3. Randomized controlled trials (RCTs) or comparative studies where the TRIGEN™ INTERTAN™ nail was a test group 4. Device used to treat extracapsular hip fractures

Exclusion criteria: 1. Meta-analyses or systematic reviews of the TRIGEN INTERTAN nail performance 2. Studies where the TRIGEN INTERTAN nail was not a test group 3. Observational studies of the TRIGEN INTERTAN nail without direct comparison to other fixation devices 4. Device used in intracapsular or femoral neck hip fractures 5. Material-, biomechanical-, or cadaveric-testing studies 6. Comparison studies of the TRIGEN INTERTAN nail with arthroplasty 7. Not published in English

Literature searchA thorough and systematic literature search was conducted using the EMBASE and PubMed databases. An additional hand search was performed with the Google Scholar database, utilizing the same search terms, to identify any articles missed in the EMBASE or PubMed searches. The searches were run to include citations from 2005 to January 2017. The search strategy is outlined in Figure 2.

Our initial search identified 233 items. Upon application of the inclusion/exclusion criteria, 224 did not meet the eligibility criteria for this review. The reasons for their ineligibility are provided in Figure 2. One additional article was identified through the hand search in Google Scholar. Therefore, ten articles were included in the current analysis3-12.

Figure 2: Literature Review

Methods

Studies identified EMBASE: 135PubMed: 98 10 Articles

included in review233

-179 Excluded Studies• Met one or more of

the exclusion criteria outlined above

-45 Excluded Studies• Met one or more of

the exclusion criteria: 20• Duplicates: 25

-179 -45+1

Title/Abstract review Full text review Hand search with Google Scholar:

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Data abstractionData were abstracted from the ten included comparative studies on the TRIGEN™ INTERTAN™ nail. All studies reported on one or more of the following endpoints, and as outlined in Table 1:

– Implant-related failure, including post-operative fracture, cut-out and/or collapse – Non-union rates – Revision or reoperation rates – Patient functional status measures, including hip and thigh pain and/or Short Form 36 health survey questionnaire (SF 36)

Implant-related failure was reported in all ten studies. Non-union rate was reported in three studies. Revision or reoperation rates were provided in eight studies. Patient functional status measures were reported in seven studies, including hip and thigh pain in six and SF 36 in one. See Table 1 for the outcomes reported in each study

Methods Cont.

Table 1: Outcomes reported in each study

StudyImplant-related failure

Non-union rate

Revision or reoperation rate

Patient functional status measures

Hip and thigh pain

SF 36

Berger-Groch, 2016 • • •

Matre, 2013 • • •

Sanders, 2017 • •

Seyhan, 2015 • • •

Su, 2016 • • •

Wang, 2014 •

Wu, 2014 • • • •

Yu, 2016 • •

Zehir, 2015 • • •

Zhang, 2013 • • • •

Statistical analysesThe outcomes for the TRIGEN™ INTERTAN™ nail were compared to the outcomes for the other standard of care (comparator) devices using the Review Manager (RevMan 5) software, a validated meta-analysis tool from Cochrane13. A standard pair-wise meta-analysis was conducted using either a fixed-effect model where there was no evidence of significant heterogeneity between studies (I2 statistic less than 50%), or a random-effects model when heterogeneity was likely (I2 statistic more than 50%). For dichotomous outcomes, odds ratio (OR) was reported as the summary statistic, and for continuous outcomes, the (weighted) mean difference (MD) was reported.

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Figure 3: Study characteristics

Number of studies:

Mean age (years):

Study designs included:

Mean sample size:

Mean follow-up:

Total number of hips

15.3 months

10

RCTs; Retrospective comparative

Bone&JointOutcome Vol 04 – No 01 – July 2017


Study characteristicsIn total, 1,994 patients were included from the ten studies: 952 for the TRIGEN™ INTERTAN™ nail group and 1,042 for the comparators, which included Sliding Hip Screws (SHS)(Compression Hip Screw, Smith & Nephew, Memphis, TN, USA; Dynamic Hip Screw [DHS] Synthes, Basel, Switzerland), Proximal Femoral Nail Antirotation (PFNA/PFNA-II, Synthes, Basel, Switzerand), and Gamma 3 nails (Stryker, Mahwah, NJ, USA). Study characteristics are summarized in Figure 3.

More detail on the study characteristics can be found in Table 2 on page 14.

Results

TRIGEN INTERTAN = 78.3 Comparators = 77.8

TRIGEN INTERTAN = 95Comparators = 104

1,994

RES

ULT

S



Stud

y, y

ear

Tota

l num

ber

pati

ents

(IN

TERT

AN

)

Tota

l num

ber

impl

ant-

rela

ted

failu

res

(INTE

RTA

N)

Tota

l num

ber

pa

tien

ts

(com

para

tors

)

Tota

l num

ber

impl

ant-

rela

ted

failu

res

(com

para

tors

)

Wei

ght

OR

[95%

con

fide

nce

inte

rval

]

OR

[95%

con

fide

nce

inte

rval

]

Randomized controlled trials

Berger-Groch, 2016 55 1 49 1 4.9% 0.89 [0.05, 14.60]

Matre, 2013 328 14 315 20 18.9% 0.66 [0.33, 1.33]

Sanders, 2017 123 13 126 13 17.8% 1.03 [0.46, 2.31]

Seyhan, 2015 32 0 43 2 4.2% 0.26 [0.01, 5.51]

Su, 2016 47 1 45 5 7.1% 0.17 [0.02, 1.55]

Zhang, 2013 47 0 46 7 4.7% 0.06 [0.00, 1.00]

Subtotal 632 29 624 48 57.7% 0.61 [0.33, 1.14]

Heterogeneity: Tau² = 0.11; Chi² = 6.03, df = 5 (P = 0.30); I² = 17% Test for overall effect: Z = 1.54 (P = 0.12)

Retrospective comparative studies

Wang, 2014 37 2 38 5 9.8% 0.38 [0.07, 2.08]

Wu, 2014 87 2 174 26 11.6% 0.13 [0.03, 0.58]

Yu, 2016 75 6 72 24 16.2% 0.17 [0.07, 0.46]

Zehir, 2015 102 0 96 13 4.8% 0.03 [0.00, 0.52]

Subtotal 301 10 380 68 42.3% 0.17 [0.08, 0.34]

Heterogeneity: Tau² = 0.00; Chi² = 2.54, df = 3 (P = 0.47); I² = 0% Test for overall effect: Z = 4.95 (P < 0.00001)

Total 933 39 1004 116 100% 0.31* [0.15, 0.62]

Heterogeneity: Tau² = 0.54; Chi² = 19.04, df = 9 (P = 0.02); I² = 53% Test for overall effect: Z = 3.30 (P = 0.001) Test for subgroup differences: Chi² = 7.28, df = 1 (P = 0.007); I² = 86.3%

0.01 1 100.1 100

Favors INTERTAN Favors comparators

Results Cont.

Implant-related failuresThe endpoints of post-operative fracture, cut-out and collapse were combined to measure implant-related failures. There was a statistically significant 69% reduction in implant-related failures with the TRIGEN™ INTERTAN™ nail versus comparator devices (p = 0.001), which included Gamma 3, SHS, PFNA and PFNA-II (39/933 implant-related failures for TRIGEN INTERTAN vs 116/1004 for comparators):

Odds Ratio 0.31 (95% CI 0.15-0.62).

Implant-related failures for each study in the analysis and the Odds Ratio are shown in Figure 4.

Figure 4: Forest Plot for Implant-related failures, TRIGEN INTERTAN versus all comparators

Results support:Lower risk of implant failure

*An Odds Ratio of 0.31 is equivalent to a 69% reduction in

implant-related failures with TRIGEN INTERTAN

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Results Cont.

Non-unionThere was a statistically significant 73% reduction in non-unions with the TRIGEN™ INTERTAN™ nail versus comparator devices, (p=0.01) which included Gamma 3, SHS and PFNA-II (4/462 non-unions for TRIGEN INTERTAN vs 18/535 for comparators): Odds Ratio 0.27 (95% CI 0.10-0.77).

Non-union events for each study included in the analysis and the Odds Ratio are shown in Figure 5.

Stud

y, y

ear

Tota

l num

ber p

atie

nts

(INTE

RTA

N)

Tota

l num

ber

non-

unio

ns

(INTE

RTA

N)

Tota

l num

ber

pati

ents

(c

ompa

rato

rs)

Tota

l num

ber

non-

unio

ns

(com

para

tors

)

Wei

ght

OR

[95%

con

fide

nce

inte

rval

]

OR

[95%

con

fide

nce

inte

rval

]


Matre, 2013 328 3 315 10 59.8% 0.28 [0.08. 1.03]

Zhang, 2013 47 0 46 3 20.7% 0.13 [0.01, 2.61]

Subtotal 375 3 361 13 80.5% 0.24 [0.07, 0.79]

Heterogeneity: Chi² = 0.21, df = 1 (P = 0.64); I² = 0% Test for overall effect: Z = 2.34 (P = 0.02)


Wu, 2014 87 1 174 5 19.5% 0.39 [0.05, 3.42]

Subtotal 87 1 174 5 19.5% 0.39 [0.05, 3.42]

Heterogeneity: Not applicable Test for overall effect: Z = 0.85 (P = 0.40)

Total 462 4 535 18 100% 0.27* [0.10, 0.77]

Heterogeneity: Chi² = 0.34, df = 2 (P = 0.84); I² = 0% Test for overall effect: Z = 2.45 (P = 0.01) Test for subgroup differences: Chi² = 0.15, df = 1 (P = 0.75), I² = 0%

Figure 5: Forest Plot for Non-unions, TRIGEN INTERTAN versus all comparators

0.01 1 100.1 100


*An Odds Ratio of 0.27 is equivalent

to a 73% reduction in non-unions

with TRIGEN INTERTAN

Results support: Lower risk of non-union

RES

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Stud

y, y

ear

Tota

l num

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atie

nts

(INTE

RTA

N)

Tota

l num

ber

revi

sion

s (IN

TERT

AN

)

Tota

l num

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pati

ents

(c

ompa

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rs)

Tota

l num

ber

revi

sion

s (c

ompa

rato

rs)

Wei

ght

OR

[95%

con

fide

nce

inte

rval

]

OR

[95%

con

fide

nce

inte

rval

]


Berger-Groch, 2016 55 2 49 1 1.9% 1.81 [0.16, 20.62]

Matre, 2013 328 28 315 27 46.5% 1.00 [0.57, 1.73]

Sanders, 2017 123 13 126 9 14.7% 1.54 [0.63, 3.74]

Su, 2016 47 1 45 5 9.2% 0.17 [0.02, 1.55]

Zhang, 2013 47 2 46 3 5.4% 0.64 [0.10, 4.00]

Subtotal 600 46 581 45 77.7% 1.00 [0.65, 1.53]



Wu, 2014 87 2 174 5 6.0% 0.80 [0.15, 4.18]

Zehir, 2015 102 5 96 9 16.3% 0.50 [0.16, 1.54]

Subtotal 189 7 270 14 22.3% 0.58 [0.23, 1.48]


Total 789 53 851 59 100% 0.90* [0.61, 1.33]

Heterogeneity: Chi² = 5.20, df = 6 (P = 0.52); I² = 0% Test for overall effect: Z = 0.52 (P = 0.60) Test for subgroup differences: Chi² = 1.06, df = 1 (P = 0.30); I²= 6.1%

Results Cont.

Revisions or re-operation ratesThere was a 10% reduction in revision in favour of the TRIGEN™ INTERTAN™ nail versus all comparators, which included Gamma 3, SHS, PFNA and PFNA-II (53/789 revisions for TRIGEN INTERTAN vs 59/851 for comparators), although this difference was not significant (p=0.60): Odds ratio 0.90 (95% CI 0.61-1.33). One study reported this outcome but there were no revisions in either study arm and hence it was not included in the statistical analysis.5

Figure 6: Forest Plot for Revision surgery, TRIGEN INTERTAN versus all comparators

0.01 1 100.1 100


*An Odds Ratio of 0.90 is equivalent

to a 10% reduction in revisions in favor

of TRIGEN INTERTAN

RES

ULT

S

Revision events for each study included in the analysis and the Odds Ratio are shown in Figure 6.



Results Cont.

Patient functional status measures

Hip and thigh painThere was a statistically significant 54% reduction in patients reporting chronic hip and thigh pain with the TRIGEN™ INTERTAN™ nail versus comparator devices (p=0.003), which included Gamma 3, PFNA and PFNA-II (25/390 reporting hip and thigh pain for TRIGEN INTERTAN vs 53/476 for comparators): Odds Ratio 0.46 (95% CI 0.28-0.77).

Hip and thigh pain cases for each study included in theanalysis and the Odds Ratio are shown in Figure 7.

Figure 7: Forest Plot of Hip and thigh pain analysis, TRIGEN INTERTAN versus comparators

Stud

y, y

ear

Tota

l num

ber o

f pat

ient

s (IN

TERT

AN

)

Tota

l num

ber

of c

ases

of

hip

and

thi

gh p

ain

(INTE

RTA

N)

Tota

l num

ber

of p

atie

nts

(com

para

tors

)

Tota

l num

ber

of c

ases

of

hip

and

thi

gh p

ain

(com

para

tors

)

Wei

ght

OR

[95%

con

fide

nce

inte

rval

]

OR

[95%

con

fide

nce

inte

rval

]


Seyhan, 2015 32 1 43 1 1.7% 1.35 [0.08, 22.51]

Su, 2016 47 3 45 4 8.1% 0.70 [0.15, 3.31]

Zhang, 2013 47 5 46 14 26.7% 0.27 [0.09, 0.83]

Subtotal 126 9 134 19 36.6% 0.42 [0.18, 0.97]



Wu, 2014 87 4 174 7 9.4% 1.15 [0.33, 4.04]

Yu, 2016 75 7 72 17 33.3% 0.33 [0.13, 0.86]

Zehir, 2015 102 5 96 10 20.7% 0.44 [0.15, 1.35]

Subtotal 264 16 342 34 63.4% 0.49 [0.26, 0.91]


Total 390 25 476 53 100% 0.46* [0.28, 0.77]

Heterogeneity: Chi² = 4.18, df = 5 (P = 0.52); I² = 0% Test for overall effect: Z = 3.00 (P = 0.003) Test for subgroup differences: Chi² = 0.09, df = 1 (P = 0.77), I²= 0%

0.01 1 100.1 100


Results support:Reduced postoperative pain

*An Odds Ratio of 0.46 is equivalent to

a 54% reduction in hip and thigh pain

with TRIGEN INTERTAN

RES

ULT

S



RES

ULT

S

Results Cont.

SF-36 scoresOne study reported on SF-36. This showed a statistically significant higher SF-36 (physical health) score in favor of the TRIGEN™ INTERTAN™ nail versus the comparator (Gamma 3) (p=0.002).

Stud

y, y

ear

Tota

l num

ber p

atie

nts

(INTE

RTA

N)

Mea

n SF

-36

scor

e (IN

TERT

AN

) [S

tand

ard

devi

atio

n]

Tota

l num

ber

pati

ents

(c

ompa

rato

rs)

Mea

n SF

-36

scor

e (c

ompa

rato

rs)

[Sta

ndar

d de

viat

ion]

Wei

ght

Mea

n di

ffere

nce

[9

5% c

onfid

ence

inte

rval

]

Mea

n di

ffere

nce

[9

5% c

onfid

ence

inte

rval

]

Berger-Groch, 2016 55 40 [13.1] 49 32.6 [11.2] 100% 7.40 [2.73,12.07]

Total 55 40 [13.1] 49 32.6 [11.2] 100% 7.40* [2.73,12.07]

Heterogeneity: Not applicable Test for overall effect: Z = 3.10 (P = 0.002)

Figure 8: SF-36 (physical health) analysis, TRIGEN INTERTAN versus comparator

-10 0 5-5 10Favors comparator Favors INTERTAN

Results support:Proven high return to pre-fracture status

*A positive mean difference favors

the test group (TRIGEN INTERTAN), and appears on the

right side of the chart

RES

ULT

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Conclusions

Compared to those treated with standard care, TRIGEN™ INTERTAN™ results in:

• A statistically significant 69% reduction in implant-related failures (p=0.001)

• A statistically significant 73% reduction in non-unions (p=0.01)

• A 10% reduction in revisions, which was not statistically significant (p=0.60)

• A statistically significant 54% reduction in patients reporting chronic hip and thigh pain (p=0.003)

• A statistically significant higher SF-36 (physical health) score, in a single study (p=0.002)

CO

NC

LUS

ION

S



Table 2: Study characteristics breakdown

Review of study characteristicsSt

udy,

yea

r

Leve

l I: R

CTs

Leve

l II:

Pros

pect

ive

com

para

tive

Leve

l III:

Ret

rosp

ecti

ve,

com

para

tive

Leve

l IV:

Cas

e se

ries

Sam

ple

size

, hip

s;

(IT v

s co

mpa

rato

r)

Mea

n ag

e, y

ears

(S

tand

ard

devi

atio

n)

% M

ale

Leng

th o

f fo

llow

up,

m

onth

s

% L

oss

to f

ollo

w u

p at

fi

nal f

ollo

w u

p

Berger-Groch, 2016104

(IT =55;Gamma 3 = 49)

IT = 81.6 (+/-9.4)Gamma 3 = 82.0

(+/-9.2)

IT = 21.8Gamma 3 = 24.5

60 (with assessments at

1.5, 3 and 6)

Total = 68.3 (60.6 died,

7.7 lost)

Matre, 2013672

(IT = 334; SHS = 338)

IT = 84.1SHS = 84.1

IT = 22.8SHS = 24.6 12

IT = 41.0 (25.1 died; 15.9 lost)

SHS = 41.7 (25.7 died; 16.0 lost)

Sanders, 2017249

(IT = 123;SHS = 126)

IT = 80.6 (+/-0.8) SHS = 81 (+/-0.8)

IT = 29.3SHS = 26.2 12 IT = 17.1

SHS = 28.3

Seyhan, 201575

(IT = 32; PFNA = 43)

IT = 75.3 (+/-13.52)

PFNA =75.9 (+/-13.71

IT = 25.0PFNA = 25.6 24$ Total = 17.3

Su, 2016 100 (IT = 50; Gamma 3 = 50)

IT = 70.1 (+/-9.2)Gamma 3 = 71.3

(+/-8.7)

IT = 42.0Gamma 3 = 38.0 12 IT = 6.0

Gamma 3 = 10.0

Zhang, 2013113

(IT = 57;PFNA-II = 56)

IT = 72.9 (+/-7.6)

PFNA-II = 72.4 (+/-8.7)

IT = 40.4PFNA-II = 33.9 12

IT = 17.5 (14.0 died, 3.5 lost)

PFNA-II = 17.9 (12.5 died, 5.4 lost)

Wang, 201475

(IT =37; DHS = 38)

IT = 61 (22-91)£;DHS = 57 (20-85)£)

IT = 48.6DHS = 71.1 11 (+/-5.6)* IT = 16.2

DHS = 21.1

Wu, 2014261

(IT = 87;Gamma 3 = 174)

IT = 71.4 (+/-9.7)Gamma 3 = 72.6

(+/-8.6)

IT = 23.0Gamma 3 = 24.7 12 IT = 0

Gamma 3 = 0

Yu, 2016

168 enrolled 147 available for analysis

IT =75PFNA-II =72

IT = 75.2 (+/-8.8)

PFNA-II = 74.2 (+/-9.1)

IT = 46.6PFNA-II = 44.4 12

Total = 13.7 (4.8 died,

4.8 too infirmed, 4.2 lost)

Zehir, 2015198

(IT = 102;PFNA = 96)

IT = 76.9 (+/-6.7)

PFNA = 77.2 (+/-6.8)

IT = 38.2PFNA = 38.5

IT = 16.0 (1-40)

PFNA = 16.1 (1-46)#

N/A

Key: IT = TRIGEN INTERTAN; N/A = not applicable; $ = Final follow up; £ = Range; * = Mean follow up (Standard deviation); # = Median follow up (Range)

REV

IEW



Appendix: An Additional Analysis of Time to Union Data

Background

The original systematic literature review (as outlined in the main document) focused only on comparative clinical studies of the TRIGEN™ INTERTAN™ nail. In this review, three randomized controlled studies reporting mean time to union data were identified. The small total patient number and heterogeneity in follow-up times in these studies meant that the data were fragile and a meta-analysis could not be conducted. Therefore, we also reviewed non-comparative studies to evaluate additional evidence concerning the performance of the TRIGEN INTERTAN nail, where sufficient comparative data did not exist.

Methods

Literature search: Additional review of non-comparative studiesThree RCTs reported mean time to union: two comparing the TRIGEN INTERTAN nail to PFNA6,12 and one to SHS 8. The small total patient number and heterogeneity in follow-up times meant that the data were fragile, and hence there was a need to expand the search criteria. Therefore, we also included non-comparative, single-arm, case series reporting on the performance of the TRIGEN INTERTAN nail for this endpoint. The additional articles were identified with the same search terms using databases as described in the main systematic review (see page 5): however, the inclusion criteria were expanded to include single-arm case series. To ensure completeness, we also sought expert opinion to ensure we did not miss any publications from the systematic search. Two non-comparative studies were identified reporting mean time to fracture union for the TRIGEN INTERTAN nail 14, 15. In order to find mean time to union rates for comparator devices, a published systematic review 16 from 2016 was used to identify appropriate publications. From this, six studies were identified.

Data abstractionAs well as the three comparative studies 6,8,12 reporting mean time to fracture union, data were collated for the TRIGEN INTERTAN nail from the two identified non-comparative studies.14, 15 Time to fracture union rates for comparator devices were collated from the three comparative studies 6,8,12 and the further six identified non-comparative studies.17–22

Statistical analysesA meta-analysis could not be conducted for the time to fracture union endpoint due to fragility of data caused by the heterogeneity in follow-up times and low total patient number. Instead, non-comparative studies were included and a non-statistically validated method was used to generate the mean time to fracture union for the TRIGEN INTERTAN nail corrected for population size, to minimize bias resulting from small studies. Here, the time to union was multiplied by the number of patients for each study: the results for each study were added and then divided by the pooled patient number. For comparator devices, time to fracture union rates were extracted from the studies identified and a mean of these results was calculated, also corrected for population size.

AP

PEN

DIX



Results

Study characteristicsFor the non-comparative studies reporting on time to fracture union for the TRIGEN™ INTERTAN™ nail, 152 patients were included from two studies (in addition to the 110 patients from comparative studies). For the non-comparative studies reporting on time to fracture union for comparator devices, 1,216 patients were included from six studies (in addition to the 119 patients from comparative studies).

Time to fracture unionMean time to fracture union was 14.1 weeks for TRIGEN INTERTAN versus 16.9 weeks for all comparators, which included SHS, PFNA and PFNA-II.

Table 3: Time to fracture union rates

Stud

y, y

ear

Leve

l I: R

CTs

Leve

l II:

Pros

pect

ive

com

para

tive

Leve

l III:

Ret

rosp

ecti

ve,

com

para

tive

Leve

l IV:

Cas

e se

ries

Tim

e to

frac

ture

uni

on

[wee

ks (r

ange

)]TR

IGEN

INTE

RTA

N

Tim

e to

fra

ctur

e un

ion

[w

eeks

(ran

ge)]

All

com

para

tors

Seyhan, 2015 9.91 (+/-3.86)*, 32 patients

9.79 (+/-2.22)*, 43 patients

Wang, 2014 11.9 (+/-1.8)*, 31 patients

13.1 (+/-2.8)*, 30 patient

Zhang, 2013 14.0 (+/-4.86)*, 47 patients

17.0 (+/-4.37)*, 46 patients

Wu, 2014 12.9 (+/- 4.4)*, 80 patients

Kim, 2015 18.3 (6-24), 72 patients.

Tao, 2013 20.7 (16.8-24.6), 45 patients

Huang, 2012 21.5 (12-52), 13 patients

Sahin, 2014 15.71 (10.22-21.2), 47 patients

Hsueh, 2010 17.5 (15-24), 937 patients

Liu, 2010 16.0 (12-25), 143 patients

Riha, 2010 10.0 (6-16), 31 patients

Mean time to fracture union 14.1 16.9

* Standard deviation

Appendix: An Additional Analysis of Time to Union Data Cont.

Conclusion

Compared to those treated with standard care, the TRIGEN INTERTAN nail results in a nearly three week faster time to fracture union. Further comparative studies are needed to strengthen the data on time to union and enable a future meta-analysis to be conducted on this outcome.

Results support:Faster time to fracture union

AP

PEN

DIX

AP

PEN

DIX

AP

PEN

DIX



References

1. National Institute for Health and Care Excellence (NICE). Hip fracture: management. Clinical guideline. 2011 (Last updated 2017). Available at: www.nice.org.uk/guidance/cg124.

2. Shamseer L, Moher D, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;349:g7647.

3. Berger-Groch J, Rupprecht M, Schoepper S, Schroeder M, Rueger JM, Hoffmann M. Five-Year Outcome Analysis of Intertrochanteric Femur Fractures: A Prospective Randomized Trial Comparing a 2-Screw and a Single-Screw Cephalomedullary Nail. J Orthop Trauma. 2016;30:483-488.

4. Matre K, Vinje T, Havelin LI, et al. TRIGEN INTERTAN intramedullary nail versus sliding hip screw:a prospective, randomized multicenter study on pain, function, and complications in 684 patients with an intertrochanteric or subtrochanteric fracture and one year of follow-up. J Bone Joint Surg Am. 2013;95:200-208.

5. Sanders D, Bryant D, Tieszer C, et al. A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures. J Orthop Trauma. 2017;31:1-8.

6. Seyhan M, Turkmen I, Unay K, Ozkut AT. Do PFNA devices and Intertan nails both have the same effects in the treatment of trochanteric fractures? A prospective clinical study. J Orthop Sci. 2015;20:1053-1061.

7. Su H, Sun K, Wang X. A randomized prospective comparison of Intertan and Gamma3 for treating unstable intertrochanteric fractures. Int J Clin Exp Med. 2016;9:8640-8647.

8. Wang Q, Yang X, He HZ, Dong LJ, Huang DG. Comparative study of InterTAN and Dynamic Hip Screw in treatment of femoral intertrochanteric injury and wound. Int J Clin Exp Med. 2014;7:5578-5582.

9. Wu D, Ren G, Peng C, Zheng X, Mao F, Zhang Y. InterTan nail versus Gamma3 nail for intramedullary nailing of unstable trochanteric fractures. Diagn Pathol. 2014;9:191.

10. Yu W, Zhang X, Zhu X, Hu J, Liu Y. A retrospective analysis of the InterTan nail and proximal femoral nail anti-rotation-Asia in the treatment of unstable intertrochanteric femur fractures in the elderly. J Orthop Surg Res. 2016;11:10.

11. Zehir S, Sahin E, Zehir R. Comparison of clinical outcomes with three different intramedullary nailing devices in the treatment of unstable trochanteric fractures. Ulus Travma Acil Cerrahi Derg, 2015;21(6:469-476.

12. Zhang S, Zhang K, Jia Y, Yu B, Feng W. InterTan nail versus Proximal Femoral Nail Antirotation-Asia in the treatment of unstable trochanteric fractures. Orthopedics. 2013;36:e288-294.

13. Cochrane. RevMan 5 (2014). Available at: http://community.cochrane.org/tools/review-production-tools/revman-5. Accessed November 30, 2016.

14. Kim JW, Kim TY, Ha YC, Lee YK, Koo KH. Outcome of intertrochanteric fractures treated by intramedullary nail with two integrated lag screws: A study in Asian population. Indian J Orthop. 2015;49:436-441.

15. Wu Y, Watson JT, Kuldjanov D, Jackman J. Rotationally stable fixation for intertrochanteric hip fractures: the Intertan experience, surgical technique, and outcomes. Techniques in Ortho. 2014;29;3:120-132

16. Nyholm AM, Palm H, Malchau H, Troelsen A, Gromov K. Lacking evidence for performance of implants used for proximal femoral fractures - A systematic review. Injury. 2016;47:586-94.

17. Liu Y, Tao R, Liu F, et al. Mid-term outcomes after intramedullary fixation of peritrochanteric femoral fractures using the new proximal femoral nail antirotation (PFNA). Injury. 2010;41:810-817.

18. Sahin EK, Imerci A, Kinik H, Karapinar L, Canbek U, Savran A. Comparison of proximal femoral nail antirotation (PFNA) with AO dynamic condylar screws (DCS) for the treatment for unstable peritrochanteric femoral fractures. Eur J Orthop Surg Traumatol. 2014;24:347-352.

19. Hsueh K, Fang C. Risk factors in cutout of sliding hip screw in intertrochanteric fractures: an evaluation of 937 patients. Int Orthop. 2010;34:1273-1276.

20. Huang FT, Lin KC, Yang SW, Renn JH. Comparative study of the proximal femoral

nail antirotation versus the reconstruction nail in the treatment of comminuted proximal femoral fracture. Orthopedics. 2012;35:e41-47.

21. Riha D, Bartoni´cek J. Internal fixation of pertrochanteric fractures using DHS with a two-hole side-plate. Int Orthop. 2010;34:877-882.

22. Tao R, Lu Y, Xu H, Zhou ZY, Wang YH, Liu F. Internal fixation of intertrochanteric hip fractures: a clinical comparison of two implant designs. Sci World J. 2013;2013:1-8.

REF

EREN

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Notes

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