Ac a O hopaedica 2016; 87 (3): 209–217
Pa ien inju ies in p ima y o al hip eplacemen
Na ionwide analysis in Finland
Teemu HELKAMAA 1, Ee o HIRVENSALO 1, 2, Heini HUHTALA 3, and Ville REMES 4
1 Depa men o O hopedics and T auma ology, Helsinki Uni e si y Cen al Hospi al; 2 Pa ien Insu ance Cen e , Helsinki; 3 School o Heal h Sciences,
Uni e si y o Tampe e, Tampe e; 4 Pihlajalinna G oup, Helsinki, Finland.
Co espondence: [email p o ec ed]
Submi ed 2015-03-03. Accep ed 2015-11-09.
© 2016 The Au ho (s). Published by Taylo & F ancis on behal o he No dic O hopedic Fede a ion. This is an Open Access a icle dis ibu ed unde he e ms
o he C ea i e Commons A ibu ion-Non-Comme cial License (h ps://c ea i ecommons.o g/licenses/by-nc/3.0)
DOI 10.3109/17453674.2015.1135662
Backg ound and pu pose — Al hough he esul s o p ima y o al
hip eplacemen s (THRs) a e gene ally excellen , some imes se i-
ous complica ions a ise. Some o hese se e e complica ions a e
conside ed o be pa ien inju ies. We analyzed p ima y THR-
ela ed pa ien inju ies in a na ionwide se ing.
Pa ien s and me hods — We e alua ed all he p ima y THR-
ela ed pa ien inju y claims in Finland be ween 2008 and 2010.
We used he o iginal medical eco ds and 2 na ionwide egis ies,
he Ca e Regis e o Social Wel a e and Heal h Ca e and he
Pa ien Inju y Claim Regis e .
Resul s — We iden i i ed 563 claims, 44% o which we e com-
pensa ed (n = 250). O hese 250 compensa ed claims, 79% we e
conside ed o be a oidable ( ea men inju ies) and 21% we e
se e e unexpec ed in ec ions (wi h a p eope a i e in ec ion isk
o less han 2%). The mos common ype o echnical e o was
cup malposi ion (31%). High- olume hospi als (wi h an annual
p ima y THR olume ≥ 400) had a lowe pa ien inju y a e. In
lowe - olume hospi als (wi h an annual p ima y THR olume o
< 400), he ela i e isks (RRs) o pa ien inju y o any eason,
due o echnical e o s, o because o cup malposi ion we e 2- old
(95% CI: 1.6–3.1), 4- old (95% CI: 2.3–6.2), and 9- old (95% CI:
3–28), espec i ely, compa ed o high- olume hospi als.
In e p e a ion — Ou s udy p o ides he i s comp ehensi e
na ionwide da a on THR- ela ed pa ien inju y ypes. Hospi al
olume was associa ed wi h he quali y and quan i y o e o s
de ec ed. An annual hospi al olume o ≥ 400 p ima y THRs was
es ablished as a p o ec i e ac o agains pa ien inju ies.
■
Al hough o al hip eplacemen (THR) is conside ed o be a
sa e p ocedu e, ea ly complica ions and e-admission a es
om 8% o 10% ha e been epo ed a e p ima y THR
(DeHa and Riley 1999, Kha od e al. 2006, Feh inge e al.
2010, Namba e al. 2012, Wol e al. 2012). Mos o hese
ea ly complica ions canno be a oided; no do hey lead o sig-
ni i can ha m o he pa ien , e.g. supe i cial wound in ec ions
(Walmsley e al. 2005). Howe e , some imes se ious and e en
a al complica ions a ise (Pa izi e al. 2001, 2007) and some
o hese can be conside ed o be pa ien inju ies.
Lea ning om acciden s is a widely used co ne s one o
sa e y analysis, and in medicine, complica ions a e an impo -
an sou ce o in o ma ion. Pa ien inju ies ha e been shown
o occu mainly du ing ou ine p ocedu es (Regenbogen e al.
2007) and hey ep esen he mo e se e e end o he spec um
o complica ions (May and S engel 1990, Sloan and Hsieh
1995, S udde e al. 2000, Bisma k e al. 2006, Dunba and
Sab y 2007). Fo a complica ion o be conside ed a pa ien
inju y in he Finnish “no- aul ” insu ance sys em, i mus
ul i ll 1 o he 7 compensa ion c i e ia de i ned in he Pa ien
Inju y Ac , and he consequences o he claiman mus be su -
i cien ly se e e (Table 1). The e o e, only a oidable o su -
i cien ly se e e complica ions may quali y as pa ien inju ies.
P ima y THR has been he leading cause o pa ien insu -
ance claims in Finland o yea s (S a is ics o Finnish Pa ien
Insu ance Cen e , 2015). In Finland, pa ien s i le a claim a e
THR up o 26 imes mo e a idly han a e hospi aliza ion in
gene al (Jä elin e al. 2012). P e ious s udies ha e indica ed
ha high- olume hospi als and su geons, con inuous ad ances
in in aope a i e ca e, and imp o ed su gical echniques may
educe pos ope a i e complica ions, mo bidi y, and mo ali y
a e p ima y THR (Pa izi e al. 1999, Ka z e al. 2001, Yasu-
gana e al. 2009, Ra i e al., 2014). The pu pose o his s udy
was o in es iga e he ypes o inju y, he mechanisms, and
he ac o s ha lead o pa ien inju ies a e p ima y THR in a
na ionwide se ing.
Pa ien s and me hods
The pa ien insu ance scheme in Finland (“no- aul ”)
No dic coun ies including Finland ha e adop ed a “no- aul ”
pa ien insu ance sys em (Mikkonen 2004) based on he con-
cep s o “p e en abili y” and “ ole abili y” a he han “neg-
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Ac a O hopaedica 2016; 87 (3): 209–217
ligence”, as in he o insu ance sys ems used in he UK and
he USA. In Finland, pa ien inju y claims a e esol ed by he
Pa ien Insu ance Cen e , and only a ely do hey ad ance o
he legal sys em and he cou s. Claims a e handled i less han
3 yea s ha e passed om he momen he pa ien became awa e
o he inju y. In i s decision making, he cen e uses ex e nal
medical expe s and all a ailable in o ma ion abou he case.
Copies o all pa ien documen s a e eques ed om he heal h-
ca e ins i u ions in ol ed in he ea men o he claiman . The
Pa ien Insu ance Cen e accep s o ejec s claims based on he
c i e ia de i ned in he Pa ien Inju y Ac (Jä elin 2012). The
main compensa ion c i e ia o ypical THR- ela ed complica-
ions a e shown in Table 1.
S udy pe iod and egis y sou ces
Pa ien inju y claims we e collec ed om he Pa ien Insu -
ance Cen e Claim Regis e (see below). The Ca e Regis e o
Social Wel a e and Heal hca e (HILMO) was used as a sou ce
o pa ien cha ac e is ics o all THR ecipien s (Table 2), and
o hospi al p ima y THR olumes (Table 3). The da a we e
collec ed om he HILMO be ween 2005 and 2010. The ime
pe iod was chosen o ensu e ha he con ol THR ecipien s
(“non-claiman s”, Table 2A–C) we e ope a ed on du ing he
same ime pe iod as he claiman s due o he allowed 3-yea
delay in claim i ling (see abo e). Al oge he , 93% o pa ien
inju y claiman s who i led a claim in he pe iod 2008–2010
had hei p ima y ope a ion be ween 2005 and 2010. The
3-yea a e age hospi al olumes we e used in he RR analy-
ses, as he pa ien inju ies we e also collec ed om he 3-yea
ime pe iod.
Pa ien Insu ance Cen e da a collec ion
Da a on all pa ien s who had i led a claim ela ing o p i-
ma y THR su ge y in Finland be ween Janua y 1, 2008 and
Decembe 31, 2010 we e collec ed om he claim egis e o
he Pa ien Insu ance Cen e . Claims ela ed o p ima y THR
wi h su gical p ocedu es NFB30–62 acco ding o he No dic
Medico-S a is ical Commi ee’s classi i ca ion o su gical p o-
cedu es (NCSP) we e included in he s udy. Pa ien s who had
hip ac u e as a cause o THR we e excluded (Figu e 1). The
o iginal pa ien documen s, adiog aphs, and claim decisions
we e e iewed (by TH) and analyzed. The in o ma ion and
a iables collec ed included pa ien cha ac e is ics (age, sex,
diagnoses), he hospi al, and de ailed cha ac e is ics o he
ope a ions (ope a ed side, su gical app oach, su geon’s expe-
ience, and ype o implan (cemen ed s. cemen less)).
Ca ego iza ion o hospi al olume
Hospi als pe o ming p ima y THRs in Finland we e ca ego-
ized in o 4 g oups acco ding o he a e age annual olume o
each hospi al be ween 2005 and 2010. O e all, 67 hospi als
we e g ouped based on olume as ollows: < 100 (g oup 1),
100–199 (g oup 2), 200–399 (g oup 3), and ≥ 400 (g oup 4).
G oup 4 hospi als (la e e e ed o as “high- olume cen e s”)
we e used as he e e ence g oup in he ela i e isk (RR) anal-
yses in Table 3, o in es iga e he e ec o hospi al olume on
ypes o pa ien inju y. O he hospi al g oups we e also com-
pa ed wi h each o he (Table 3). No uni o m ca ego iza ion
o hospi al olume exis s in he li e a u e. The high- olume
g oup 4 hospi als we e all uni e si y eaching hospi als.
Analysis o associa ed ac o s
We in es iga ed how di e en ac o s (age, sex, p ima y diag-
nosis, ope a ion ype, and annual p ima y THR olume o he
ope a ing hospi al) we e associa ed wi h claim i ling and claim
Table 1. Compensa ion c i e ia
Main c i e ia a: Compensa able i :
T ea men inju y An expe ienced clinician would ha e ac ed
di e en ly and hus a oided he se e e
ha m and/o inju y o he pa ien .
In ec ion inju y Based on pa ien ’s como bidi ies and
medica ions, he p eope a i e in ec ion isk
is below 2% and he consequences o he
pa ien a e su i cien ly se e e.
Un easonable inju y A se e e inju y ha led o pe manen ha m
o dea h and was unp edic able judging by
he illness and heal h s a us in gene al and
he heal hca e o medical ca e gi en.
Speci i c ea men inju y e en s: Compensa able i b:
Pos ope a i e in ec ion The pa ien has su e ed a DSSI ha has
led o se e e consequences e.g. (1–) 2
subsequen eope a ions/ e isions o
pe manen emo al o he implan (Gi dle-
s one p ocedu e) and p olonged a e ca e.
Cup o s em malposi ion Componen malposi ioning leading o sig-
ni i can clinical symp oms/ad e se e en
leading o eope a ion(s). Could ha e been
a oided wi h mo e ca e ul su gical execu-
ion.
Cup o s em ins abili y Componen ins abili y could ha e been
a oided wi h mo e ca e ul su gical execu-
ion, and has led o a eope a ion.
Leg leng h disc epancy Unplanned pos ope a i e leg leng h dis-
c epancy o mo e han 1.5 cm.
F ac u e The ac u e has been o e looked du ing
he ope a ion o he os eosyn hesis has
been inadequa e.
Ne e o ascula inju y Inabili y o p o ec he su ounding ne es
o ascula u e du ing he ope a ion (e.g.
documen ed di ec inju y, inabili y o loca e
and p o ec he ischias ne e when using
pos e ola e al app oach, unin en ional
leg leng h disc epancy leading o pa esis,
se e e ascula inju y).
Delay in ea men A delay ha has led o he se e e ha m/
inju y o he pa ien .
Insu i cien diagnos ics Some signi i can clinical o adiological
i ndings ha e been o e looked o misdiag-
nosed, leading o se e e ha m/inju y o he
pa ien .
a De i ned in de ail in he Pa ien Inju y Ac (Jä elin e al. 2012).
b Each claim is e alua ed indi idually; hus, he c i e ia he e a e
di ec ional.
DSSI: deep su gical si e in ec ion.
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decisions. We also de e mined whe he pa ien s ope a ed on in
a ious olume hospi als di e ed ega ding hese ac o s.
Classi i ca ion o compensa ed ea men inju ies
The Pa ien Inju y Ac ca ego izes all compensa ed claims
in o 7 classes. We di ided he ea men inju ies in o 6 sub-
classes, which we e u he analyzed and di ided acco ding o
he ype o e o o he inju y mechanism. The classi i ca ion o
compensa ed pa ien inju ies is shown in Figu e 2.
S a is ics
Unless o he wise s a ed, analyses we e conduc ed using he
chi-squa e es . Logis ic mul i a ia e eg ession models we e
used when pa ien -speci i c a iables we e a ailable, and hey
we e es ed using STATA 12 so wa e. S a is ical signi i cance
was se a an alpha le el 0.05. Rela i e isk and 95% con i -
dence in e als (CIs) we e calcula ed acco ding o Ga dne and
Al man (1994). G oup 4 hospi als we e used as he e e ence
g oup in RR calcula ions. The numbe o ea men s needed o
cause a compensa able echnical e o o lowe - olume hos-
Common p oblems aised by claiman s we e pain and/o dis-
sa is ac ion wi h he unc ion o he a i i cial hip join . One o
bo h we e add essed in he majo i y o he claims associa ed
wi h ea men inju ies. Some o he speci i c clinical p oblems
epo ed by claiman s in hei claims included in ec ions (n =
121), ne e damage (n = 111), leg leng h disc epancy (n = 85),
ac u e ea men (n = 55), disloca ion (n = 41), and delay in
ea men (n = 17). The compensa ion a es o hese we e as
ollows: in ec ions 44%, ne e damage 36%, leg leng h dis-
c epancy 28%, ac u e ea men 20%, disloca ions 71%, and
delays in ea men 35%.
Pa ien - ela ed and ope a ion- ela ed a iables asso-
cia ed wi h pa ien inju ies
THR ecipien s we e mo e inclined o i le a claim i hey
we e unde 65 yea s o age, i hey we e ope a ed wi h ully
cemen less implan s, o i hey we e ope a ed in hospi als
ha pe o med less han 400 p ima y THRs annually (Table
2A–C). In ec ion claiman s we e also mo e o en males and
mo e o en ope a ed in g oup 1–3 hospi als (Table 2B). Com-
pi als (g oups 1–3) was calcula ed based on
absolu e isk educ ion (Cook and Sacke
1995, Bende 2001).
E hics
Pe mission o ca y ou he s udy was
ob ained om he Finnish Minis y o Social
A ai s and Heal h (STM/4724/2011). The
s udy was conduc ed acco ding o he Dec-
la a ion o Helsinki. Da a handling was pe -
o med acco ding o Finnish da a p o ec ion
legisla ion.
Resul s
Du ing he s udy pe iod, 563 THR- ela ed
claims we e esol ed by he Pa ien Insu -
ance Cen e (Figu e 1). The incidences o
all i led claims and o i led in ec ion claims
du ing he s udy pe iod we e 2.6% and
0.6%, espec i ely. O all he claims i led,
44% we e compensa ed (Figu e 2). O all
he compensa ed claims, 79% we e ea -
men inju ies and 21% we e in ec ion inju-
ies (Figu e 2). The incidences o compen-
sa ed claims and o compensa ed in ec ions
we e 1.2% and 0.2%, espec i ely. The
o e all isk o pa ien inju ies was lowe
o pa ien s who we e ope a ed on in high-
olume hospi als (G oup 4) (Table 3).
Pa ien - epo ed easons o i ling a
claim
Figu e 1. Flow cha o da a collec ion. NFB: any p ima y hip a h oplas y ope a ion; NFC: any
hip e ision ope a ion; NFJ: any hip ac u e ope a ion; NGB: any p ima y knee a h oplas y;
NGC: any e ision knee a h oplas y. a 2 claims o 10 we e om high- olume hospi als (g oup
4). 9 claims we e ea men inju y claims, and 1 was an in ec ion claim (g oup 3).
Insu ance claims eco ded as
p ima y THA (NFB30–62)
n = 590
Compensa ed p ima y THR claims
n = 264
Non-compensa ed claims
n = 326
Excluded (n = 39):
– Ope a ion because o hip
ac u e (n = 20)
– Regis y e o s (n = 9)
– O iginal pa ien eco ds
una ailable o decision
pending (n = 10)
b
Included compensa ed p ima y THR claims
n = 250
T ea men inju ies
n = 197
In ec ion inju ies
n = 53
Included ( egis y e o s)
n = 12
All pa ien inju y claims in Finland associa ed
wi h hip su ge y (NFB
a
, NFC
a
, NFJ
a
)
be ween yea s 2008 and 2010
n = 934
O he han NFB30–62
n = 344
Non-compensa ed
pa ien inju y claims
n = 313
n = 26
Reco ded as compensa ed
n = 141
Claims egis e ed wi h su gical
codes NGB
a
o NGC
a
(n = 641)
n = 13
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Compensa ed
pa ien inju ies
(n = 250)
T ea men
inju ies (n = 197)
In ec ions
(n = 53)
Unjus ified
ope a ion
(n = 5)
Pe iope a i e
echnical e o s
(n = 189)
Cup side
e o s
(n = 80)
O he
e o s
(n = 28)
Inadequa e
ac u e ea men
(n = 22)
Mul iple
e o s
(n = 36)
d
• Ins able
implan
• Malposi ion
Classifica ion o
compensa ion c i e ia
based on Pa ien Inju y
Ac (n = pa ien s)
De ailed g ounds o
compensa ions
(n = pa ien s)
T ea men delay
o insu icien
a e ca e (n = 9)
Technical e o ype
(n = pa ien s)
• Missed ac u e
in aope a i ely
• Inadequa e
os eosyn hesis
• Di ec inju y e.g. cu ,
su u e, blun auma
• Ne e no iden ified
using pos e ola e al
app oach
• Dis ension e.g. leg
leng h disc epancy
• Unclea mechanism
21%
79%
96%
3%
5%
42%
12%
15%
Mul iple
g ounds
(n = 10)
5%
• Cemen ing
p oblems
• Inadequa e
closu e
•Incompa ible
componen s
S em side
e o s
(n = 54)
29%
10
% b
Leg leng h
disc epancy
(n = 19)
c
•
Ins able
implan
•
Malposi ion
19%
2%
Insu icien
diagnos ics
(n = 4)
23%
De ailed mechanisms
o inju ies
Failu e o p o ec he
su ounding s uc u es
(n = 43)
a
Figu e 2. Types o pa ien inju y. a Ne e o ascula lesions/inju ies. b Pe cen age (%) o all pe iope a i e echnical e o s. c Unplanned leg leng h
di e ence o > 2 cm due o s em malposi ion. d Two pa ien s had 3 e o s.
Table 2. Pa ien and ope a ion cha ac e is ics (exp essed as %)
Age Sex Diagnosis Ope a ion Hospi al olume
n ≥ 65 < 65 Men Women POA a O he NFB30 b O he ≥ 400 < 400
A Non-claiman s 42,579 58 42 44 56 86 14 52 48 33 67
All claiman s 563 52 48 43 57 86 14 58 42 21 79
p- alue 0.005 c 0.6 0.6 0.005 c < 0.001 c
B Non-claiman s 43,021 58 42 44 56 86 14 52 48 33 67
In ec ions 121 57 43 61 39 89 11 54 46 23 77
p- alue 0.9 < 0.001 c 0.4 0.8 0.03 c
C Non-claiman s 42,700 58 42 44 56 86 14 52 48 33 67
T ea men inju ies 442 47 53 38 62 85 15 60 40 21 79
p- alue < 0.001 c 0.01 c 0.3 0.002 c 0.001 c
D Denied 313 50 50 41 59 84 16 58 42 24 76
Compensa ed 250 48 52 45 55 87 13 58 42 18 82
p- alue 0.2 0.3 0.3 1.0 0.05
E < 400 (g oup 1–3) 443 52 48 44 56 88 12 58 42 … …
≥ 400 (g oup 4) 120 50 50 40 60 76 24 58 42 … …
p- alue 0.4 0.4 < 0.001 c 0.5
The pa ien and ope a ion cha ac e is ics o o al hip eplacemen (THR) ecipien s in Finland be ween 2005 and 2010 a e
p esen ed as pe cen ages o all in he g oup. Pa ien s we e cha ac e ized based on age, sex, and diagnosis. Ope a ions
we e cha ac e ized based on ope a ion ype and hospi al olume. Lines A, B, and C show he compa ison o a iables
associa ed wi h claim i ling among all claiman s, in ec ion claiman s, and ea men inju y claiman s compa ed o all THR
ecipien s who did no i le a claim (“non-claiman s”). Rows ma ked D show a compa ison o he cha ac e is ics o denied
and compensa ed claiman s. Rows ma ked E show he cha ac e is ics o pa ien s who we e ope a ed in high- olume
hospi als (g oup 4) and lowe - olume hospi als (g oups 1–3).
a P ima y os eoa h osis (POA).
b Cemen less THR based on NOMESCO classi i ca ion o su gical codes.
c S a is ically signi i can . Calcula ed using chi-squa e es . Any p- alues < 0.05 we e conside ed s a is ically signi i can .
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pa ed o g oup 4 hospi als, o THR ecipien s who we e ope -
a ed in g oup 1–3 hospi als, he RRs o i ling a claim o any
eason—due o in ec ion o due o ea men inju y—we e 1.8
(CI: 1.5–2.2), 1.6 (CI: 1.1–2.4), and 1.8 (CI: 1.5–2.3), espec-
i ely (Table 3). None o he a iables we e associa ed wi h
Pa ien Insu ance Cen e claim decisions (Table 2D). Since a
highe p opo ion o denied claims in g oup 4 hospi als was
no ed (p = 0.05), a mul i a ia e logis ic eg ession model anal-
ysis was also conduc ed. Analysis showed only a end (odds
a io (OR) = 1.5, CI: 0.97–2.3; p = 0.07). Pa ien s ope a ed
in high- olume cen e s (g oup 4) we e o he wise simila o
THR ecipien s ope a ed in lowe - olume hospi als (g oups
1–3) o all pa ien - ela ed and ope a ion- ela ed cha ac e is-
ics, bu s a is ically signi i can ly mo e pa ien s wi h second-
a y causes o os eoa h i is we e ope a ed on in high- olume
cen e s (g oup 4) han in g oup 1–3 hospi als (Table 2E).
Types o inju y
Compensa ed THR- ela ed pa ien inju ies we e di ided in o
2 ca ego ies: ea men inju ies and in ec ion inju ies (Figu e
2 and Table 3).
T ea men inju ies and echnical e o s
On a e age, e e y 109 h and 140 h THR esul ed in compen-
sa ed ea men inju y and compensa ed in aope a i e echni-
cal e o , espec i ely. In aope a i e echnical e o s we e he
single mos equen ly compensa ed ype o ea men inju y
de ec ed. Malposi ion o he cup was he mos common ype
o in aope a i e echnical e o (31%) based on he Insu ance
Cen e expe e alua ions. Almos hal (47%) o pa ien s wi h
cup malposi ion had disloca ion a e hei p ima y ope a-
ion and 85% o compensa ed claiman s wi h disloca ion had
a malposi ioned cup. Malposi ion o he s em was he mos
common compensa ed e o on he emo al side. I accoun ed
o 61% o s em-side echnical e o s, 58% o which esul ed
in leg leng h disc epancy. Inabili y o p o ec he su ound-
ing ne es and blood essels was a eason o compensa ion
in 43 echnical e o claims (22%). 3 o hese we e ascula
inju ies, all o which we e ope a ed on using he an e ola e al
(Ha ding) app oach. O all ne e inju ies, a di ec inju y was
de ec ed in one- hi d o cases. O all claiman s compensa ed
o ne e inju ies, wo- hi ds had been ope a ed on ia he
pos e ola e al app oach.
Table 3. The ela i e isks (RRs) o claims, pa ien inju ies, and speci i c echnical e o ypes in G oups 1–3 wi h G oup 4 as e e ence g oup
Hospi al g oup (annual olume) a
All G oup 4 (≥ 400) G oup 3 (200–399) G oup 2 (100–199) G oup 1 (< 100)
n = 21,571 b n = 7,032 b n = 3,525 b n = 6,326 b n = 4,688 b
n n n RR (95% CI) n RR (95% CI) n RR (95% CI)
Risks o i led claims:
All 563 120 98 1.6 (1.3–2.1) d 205 1.9 (1.5–2.4) d 140 1.8 (1.4–2.2) d
In ec ion 121 28 18 1.3 (0.7–2.3) 47 1.9 (1.1–3.0) d 28 1.5 (0.9–2.5)
T ea men inju y 442 92 80 1.7 (1.3–2.3) d 158 1.9 (1.5–2.5) d 112 1.8 (1.4–2.4) d
Risks o compensa ed claims:
All 250 44 40 1.8 (1.2–2.8) d 106 2.7 (1.9–3.8) d,e 60 2.1 (1.4–2.4) d
In ec ion (in ole able inju y) 53 12 6 1.0 (0.4–2.7) 23 2.1 (1.1–4.3) d 12 1.5 (0.7–3.3)
T ea men inju y (a oidable inju y) 197 32 34 2.1 (1.3–3.4) d 83 2.9 (1.9–4.3) d 48 2.3 (1.4–3.5) d
Risks o speci i c a oidable inju ies:
Any echnical e o 189 30 31 2.1 (1.3-3.4) d 83 3.1 (2.0-4.7) d 45 2.3 (1.4-3.6) d
Any cup-side e o 80 6 14 4.7 (1.8–12) d 40 7.4 (3.1–18) d 20 5.0 (2.0–12)
Cup malposi ion 58 3 9 6.0 (1.6–22) d 29 11 (3.3–35) d 17 8.5 (2.5–29)
d
Any s em-side e o 54 10 7 1.4 (0.5–3.7) d 23 2.6 (1.2–5.4) d 14 2.1 (0.9–4.7) d
S em malposi ion 33 6 3 1.0 (0.3–4.0) 15 2.8 (1.1–7.2) d 9 2.3 (0.8–6.3) d
Ins able implan 44 7 9 2.6 (1.0–6.9) 19 3.0 (1.3–7.2) d 9 1.9 (0.7–5.2)
Implan malposi ion 99 11 12 2.2 (1.0–4.9) 47 4.8 (2.5–9.2) d, 29 4.0 (2.0–7.9) d
Ne e and ascula inju ies 43 13 7 1.1 (0.4–2.7) 16 1.4 (0.7–2.8) 7 0.8 (0.3–2.0)
Leg leng h disc epancy 19 6 3 1.0 (0.3–4.0) 8 1.5 (0.5–4.3) 2 0.5 (0.1–2.5)
F ac u e ea men 22 2 4 4.0 (0.7–23) 8 4.5 (0.9–21) 8 6.0 (1.3–28) d
O he su gical e o s c 29 1 5 10 (1.2–85) d 9 10 (1.3–79) d 14 21 (2.8–160) d
Mul iple echnical e o s 34 1 5 10 (1.2–85) d 12 12 (1.6–95) d 16 22 (3.0–170) d
Table shows he ela i e isks (RRs) and 95% con i dence in e als (CIs) when g oup 4 hospi als we e he e e ence g oup (RR = 1.00). No
signi i can di e ences be ween g oup 1 and g oup 3 hospi als o be ween g oup 1 and g oup 2 hospi als we e de ec ed.
a A e age annual p ima y THR olume o each hospi al in he g oup.
b 3-yea a e age olume o all hospi als in he g oup calcula ed be ween he yea s 2005 and 2010.
c Compensa ed e o s associa ed wi h closu e, cemen ing, d ain pipe emo al, ailu e o emo e os eophy es, un ounded use o special
implan s, o use o non-compa ible componen s.
d S a is ically signi i can alues compa ed o ≥ 400 hospi als.
e and show he s a is ically signi i can alues compa ed o g oup 3 hospi als (RR o g oup 3 = 1.00).
e RR = 1.5 (95% CI: 1.0–2.1). RR = 2.2 (95% CI: 1.2–4.1).
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In ec ion inju ies
All compensa ed in ec ion inju ies (n = 53) we e deep su gical
si e in ec ions. The RR o i ling a claim because o in ec ion
was highe in males (RR = 1.6, CI: 1.0–2.4) (Table 2) and in
pa ien s who we e ope a ed on in g oup 1–3 hospi als (Table
3). Compa ed o high- olume cen e s, he isk o in ec ion
inju ies ha we e compensa ed was s a is ically signi i can ly
highe in g oup 2 hospi als only (Table 3).
Fac o s associa ed wi h pa ien inju ies
Hospi al olume. An annual hospi al olume abo e 400 p i-
ma y THRs was associa ed wi h ewe i led claims, ewe
compensa ed claims, and ewe compensa ed echnical e o s
(Figu e 3 and Table 3).
High- olume cen e s (g oup 4) pe o med 34% o all THRs
in Finland. E en so, hese hospi als accoun ed o only 21% o
he i led claims and o 18% o he compensa ed pa ien inju-
ies (Figu e 3A). Fo pa ien s who we e ope a ed on in g oup
1–3 hospi als, he RR o compensa ions o any eason we e
inc eased o e 2- old (RR = 2.3, CI: 1.6–3.1), and o ech-
nical e o s almos 3- old (RR = 2.6, CI: 1.7–3.8) (Table 3).
The numbe needed o ea o cause an unnecessa y compen-
sa able in aope a i e echnical e o o lowe - olume hospi-
als (g oups 1–3) was 150 (CI: 112–228), meaning ha e e y
150 h THR pe o med in lowe - olume hospi als esul ed in a
pa ien inju y ha could ha e been a oided by ope a ing he
pa ien in a high- olume join cen e (g oup 4).
The quali y o echnical e o s was also di e en depend-
ing on he hospi al olume (Table 3). Pos ope a i e leg leng h
disc epancy and in aope a i e ne e damage we e he only
a oidable e o ypes de ec ed a a simila a e in all hospi als.
In g oup 4 hospi als, howe e , hese 2 e o ypes accoun ed
o 60% o all compensa ed echnical e o s, whe eas in g oup
1–3 hospi als he co esponding pe cen age was 23%. Ins ead,
he isk o echnical e o s classi i ed as “o he e o s” was 13
(CI: 2–96) imes highe o pa ien s who we e ope a ed on in
g oup 1–3 hospi als a he han g oup 4 hospi als (Table 3).
Su geons
Compensa ed in aope a i e echnical e o s (n = 189) we e
dis ibu ed among 112 su geons. 2 su geons wi h he mos
pa ien inju ies had ope a ed on 8% o all pa ien s who we e
compensa ed due o echnical e o s. Only 9 su geons had
mo e han 1 compensa ed echnical e o pe yea . These 9
su geons had ope a ed on 24% o all claiman s who we e
compensa ed due o echnical e o s, and hey p oduced 53%
mo e compensa ed echnical e o s han all g oup 4 hospi als
oge he . Some o hese 9 su geons ope a ed in se e al di e -
en hospi als. The indi idual THR olumes o Finnish o ho-
pedic su geons a e no a ailable in any egis e . Thus, o mini-
mize he possibili y ha a small numbe o su geons migh
explain he associa ion de ec ed be ween hospi al olume and
pa ien inju ies, we excluded all 9 su geons wi h mo e han
one echnical e o pe yea om he hospi al olume e ec
calcula ions. A e his exclusion, he isk o compensa ion in
g oup 1–3 hospi als o any eason was s ill o e 2- old (RR =
2.2, CI: 1.5–3.3), and o echnical e o s almos 3- old (RR
= 2.9, CI: 1.7–4.9), compa ed o ha o high- olume join
cen e s (Table 3).
Figu e 3. Hospi al olume and pa ien inju ies. A. The associa ion be ween high THR olume and lowe incidence o claims
i led, compensa ed claims, and pe iope a i e echnical e o s. B. The numbe o compensa ed claiman s wi h a oidable ech-
nical e o s in each indi idual hospi al pe o ming o al hip eplacemen s (THRs) ela i e o hospi al olume. Hospi als wi h
o e 50 p ima y THRs pe yea we e included. The hick ed line ep esen s he a e age a e o compensa ed claiman s wi h
pe iope a i e echnical e o s in Finnish hospi als. Hospi als below he line pe o med be e han he na ional a e age.
0
10
20
30
40
50
60
THRs
pe o med a
(n = 43,142) (n = 563)
Claims
filed
Compensa ed
claims
(n = 250)
Pe iope a i e
echnical
e o s
(n = 189)
Pe cen age o o al o each a iable
<100 (G oup 1)
100–199 (G oup 2)
200–399 (G oup 3)
≥400 (G oup 4)
AB
0
5
10
15
20
25
30
35
0 200 400 600 800 1000 1200
Numbe o claiman s wi h compensa ed
pe iope a i e echnical e o s
A e age annual numbe o
p ima y THRs pe o med
A e age e o a e
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214 Ac a O hopaedica 2016; 87 (3): 209–217
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Discussion
Complica ions a e impo an ou come measu es o he quali y
o medical ca e. Pa ien inju ies a e usually a oidable compli-
ca ions due o echnical e o s o unexpec ed in ec ions, and
be e ep esen he mo e se e e end o he spec um o com-
plica ions. To ou knowledge, he p esen s udy is he i s o
p o ide a comp ehensi e na ionwide analysis o THR- ela ed
pa ien inju ies, using he o iginal pa ien eco ds.
Almos 80% o he pa ien inju ies in Finland we e caused
by a oidable e o s ( ea men inju ies). The a e age inci-
dence o compensa ed ea men inju ies was 1 inju y pe 109
THRs. The as majo i y o hese we e in aope a i e echni-
cal e o s, o which cup malposi ion was he mos common
ype o e o . Acco ding o a egis y analysis o almos
180,000 e isions, disloca ions and echnical e o s a e mainly
ela ed o inco ec o ien a ion o he implan and he second
leading cause o e isions in Sweden (a e asep ic loosening)
(Malchau e al. 2002). Ano he s udy moni o ing he quali y
o THR ound ha app oxima ely 25% o all THRs ailed due
o ac o s ela ed o echnical e o s (Biau e al. 2011). The
ypes o inju y and hei equencies ound in he p esen s udy
we e also e y simila o hose epo ed ea lie o closed mal-
p ac ice claims o THR ecipien s in he USA (Ma sen e al.
2013). Ace abula -side e o s ha e p e iously been shown o
accoun o hal o all echnical e o s in THRs (Biau e al.
2009, 2011), and up o 60% o ace abula componen s ha e
been shown o be in a subop imal posi ion, depending on he
a ge anges used (Ba ack e al. 2013, Lee e al. 2014). Ou
esul s a e in line wi h he li e a u e. Wha ou s udy adds o
his knowledge is ha echnical e o s a e a clinically impo -
an sou ce o se e e complica ions (pa ien inju ies) and ha
hey a e associa ed wi h he THR olume o he hospi al.
The o e all isk o pa ien inju y a e THR was lowe in
hospi als wi h an annual olume abo e 400 THRs despi e
he ac ha pa ien s ope a ed in hese hospi als mo e o en
had seconda y causes o os eoa h i is and he e o e a highe
deg ee o su gical complexi y. The e was also a di e ence in
he quali y o he e o s de ec ed be ween high- olume hos-
pi als and lowe - olume hospi als. I has been epo ed p e-
iously ha high- olume su geons and hospi als ha e less
complica ions in p ima y THR su ge y (La e nia and Guzman
1995, K ede e al. 1997, 1998, No on e al. 1998, Ba aglia
e al. 2006, Ra i e al. 2014). One explana ion o his migh
be he be e ou ines o highly specialized su geons and s a
in high- olume cen e s. The e we e also hospi als o g oups
1–3 wi h a low incidence o pa ien inju ies. The ela i ely
sho s udy pe iod and also chance may pa ly explain his.
I migh also be ha he quali y o pe o mance in some o
hese hospi als is a same le el as in he high- olume cen e s.
A small g oup o o hopedic su geons (n = 9) pe o med 24%
o all he THRs wi h epo ed compensa ed echnical e o s in
Finland, and p oduced o e 50% mo e echnical e o s han
he 4 la ges join cen e s pu oge he . Al hough we we e no
able o analyze he indi idual su geon olumes, his g oup o
su geons wi h he mos echnical e o s does no explain he
associa ion be ween lowe hospi al olume and highe inci-
dence o pa ien inju ies. When hese 9 su geons we e ana-
lyzed mo e closely, i was no ed ha some ope a ed in di e -
en hospi als and ha some we e he heads o hei o hopedic
depa men s. Bo h o hese i ndings highligh essen ial l aws
in he cu en supe iso y p ocess. When sel -e alua ion is
p ac iced o when heads o o hopedic depa men s who a e
esponsible o supe ision a e only awa e o wha happens
in hei own hospi al, i is i ually impossible o con ol and
elimina e hese isk ac o s. Be e coo dina ion and co ec i e
measu es in he hospi als by he hospi al adminis a ion—o
es ablishmen o a na ionwide supe ision body ocusing on
benchma ked pe o mance s anda ds—would he e o e be
bene i cial. A public egis e and open epo ing o hospi al-
and su geon-le el pe o mance in a way ha he Na ional
Ins i u e o Heal h and Ca e Excellence (NICE) in he UK
ope a es would be a aluable ool o his kind o supe iso y
body, enhancing sa e y and imp o ing pa ien ca e in endo-
p os he ic su ge y.
When conclusions a e being d awn om s udies in es i-
ga ing pa ien inju ies, one has o ake in o accoun ha he
spec um o complica ions de ec ed is somewha skewed,
since a la ge p opo ion o ad e se e en s a e nei he com-
pensa able no a oidable, e.g. supe i cial in ec ions (Walms-
ley e al. 2005). Fu he mo e, only some o all he complica-
ions quali y as pa ien inju ies—and hese ep esen he mo e
se e e end o he spec um o complica ions. Ou s udy he e-
o e highligh s wha kinds o a oidable se e e complica ions
occu a e THR. Also, epo ing bias has o be accoun ed o .
I has been sugges ed ha only 3% o all pa ien s who a e eli-
gible o compensa ion (se e e complica ions) e e i le claims
(S udde e al. 2000, Bisma k e al. 2006, Jä elin 2012).
The a e age a e o pa ien inju y claims a e hospi aliza-
ion a ies be ween 0.1% and 0.3% (Pukk e al. 2003, Jä elin
2012). In he p esen s udy, 2.6% o all THR ecipien s i led
a pa ien inju y claim and 1.2% we e compensa ed. The inci-
dences we e simila o hose no ed ea lie in Finland, be ween
1998 and 2003 (Jä elin e al. 2012). This shows ha THR
ecipien s i le pa ien inju y claims up o 26 imes mo e o en
han pa ien s in gene al a e hospi aliza ion. A he same ime,
he claim ejec ion a e among THR ecipien s is simila o he
a e age claim ejec ion a e in he Pa ien Insu ance Cen e . I
is he e o e clea ha he THR- ela ed pa ien inju ies ha a e
compensa ed (1.2%) ep esen mo e han 3% o se e e com-
plica ions, because se e e complica ions ha a e eligible o
compensa ion a e no expe ienced by 40% o THR ecipien s.
This be e co e age is mos likely due o he subs an ially
highe claim a e de ec ed among THR ecipien s. Al hough
many complica ions a e no epo ed, he mechanisms behind
he ad e se e en s epo ed a e mos likely simila o hose
behind complica ions in gene al (Jä elin 2012). S udies
in es iga ing pa ien inju ies a e he e o e an impo an sou ce
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o in o ma ion abou he ac o s and mechanisms behind he
se e e complica ions in THR.
S eng hs and limi a ions
The s eng hs o ou s udy included he la ge pa ien coho
and he p ospec i ely collec ed egis y da a. We used 2 com-
p ehensi e na ionwide egis e s in he da a collec ion and in
he analyses. Pa ien inju y claims we e collec ed om he
egis y da a o he Pa ien Insu ance Cen e , which manages
all pa ien inju y claims in Finland. Each pa ien inju y claim
and decision (including pa ien eco ds and adiog aphs) was
indi idually assessed by a specialis in he i eld o endop os-
he ic su ge y (TH). In Finland, ope a i e ea men s in hospi-
als a e hea ily subsidized, wi h ew socioeconomic ba ie s,
esul ing in na ional egis y da a ha is highly gene alizable.
The no- aul insu ance sys em also limi s socioeconomic ba -
ie s, as claim i ling and handling a e always ee o cha ge o
claiman s. We combined se e al di e en da a sou ces, which
has been sugges ed o u he s eng hen he gene alizabili y
o pa ien inju y s udies (Jä elin 2012). Al hough Finland
and o he No dic coun ies use he no- aul insu ance sys em,
many o he coun ies ely on o sys ems. This migh a ec
he gene alizabili y o hese esul s beyond No dic coun ies.
Howe e , a ecen s udy om he USA (Ma sen e al. 2013)
ound simila echnical e o ypes and a es in THR o hose
in ou s udy. High- olume hospi als (g oup 4) had less pa ien
inju ies. Se e al di e en a iables such as pa ien awa eness,
age, sex, and socioeconomic s a us may a ec he likelihood
ha a pa ien will i le a claim a e an ad e se e en (S ud-
de e al. 2000, Bisma k e al. 2006, Dunba and Sab y 2007).
None o he a iables in es iga ed explained he be e pe o -
mance o high- olume cen e s. I has also been sugges ed ha
hospi al cul u e (ac i e in o ma ion on pa ien insu ance) and
pa ien awa eness ha e an in l uence on he likelihood ha a
pa ien will i le a claim. This is undoub edly ue; howe e , he
di e ences be ween indi idual hospi als will mos likely be
e ened ou in a na ionwide s udy. The e was a end ha claims
by THR ecipien s om lowe - olume hospi als (g oups 1–3)
we e mo e o en accep ed. This migh be explained by he
di e ence in he quali y o e o s be ween high- olume join
cen e s and o he hospi als. Finally, we lack in o ma ion on
he su ge y olumes o indi idual su geons, which has been
associa ed wi h complica ion a es a e THR. Un o una ely,
hese da a we e no a ailable in any egis ies. Thus, we could
no de e mine how su geon olume ela es o pa ien inju ies
in THR. In con as , in Finland hospi al olumes gi e an indi-
ca ion o he olumes o su geons ope a ing in hose hospi als
because, as a ule, su geons a ely ope a e in mo e han one
hospi al.
Conclusion
This is he i s na ionwide s udy o in es iga e THR- ela ed
pa ien inju ies in de ail. We ha e p esen ed he ypes and e-
quencies o se e al complica ions, ad e se e en s, and ypical
a oidable echnical e o s leading o pa ien inju ies. We ha e
also shown ha a high annual hospi al olume (abo e 400
THRs) is associa ed wi h a lowe incidence o i led claims,
pa ien inju ies, and a oidable echnical e o s. In Finland, all
high- olume hospi als a e uni e si y hospi als. Indi idual su -
geons play a key ole in educing a oidable pa ien inju ies
in THR. These i ndings p o ide impo an new in o ma ion
o conside ing p e en i e measu es agains he complica ions
and pa ien inju ies in p ima y THR su ge y. In some coun-
ies, he THR pe o mance o hospi als is epo ed and pub-
lished so ha anyone can ollow he pe o mance o one hos-
pi al and compa e i wi h ha o o he hospi als. These kinds
o well-main ained egis y could also gi e in o ma ion abou
he indi idual su geon’s pe o mance, a leas o su geons
hemsel es, and migh imp o e pa ien ca e. Awa eness o he
usual e o s ela ed o THR and he causes o pa ien inju ies
should lead o imp o ed pa ien sa e y h ough imp o ed sys-
ems o ca e.
All he au ho s con ibu ed o he concep ion and design o he s udy, o c i i-
cal analysis o he da a, o in e p e a ion o he i ndings, and o c i ical e i-
sion o he manusc ip . The au ho s w o e he manusc ip oge he . HH and
TH pe o med he s a is ical analysis.
We hank Reima Palonen and Saija Leh inen o he Pa ien Insu ance Cen e
o hei in aluable assis ance and help. We also hank Mikko Pel ola o he
Na ional Ins i u e o Heal h and Wel a e (THL) o his c ucial help wi h
HILMO da a.
No compe ing in e es s decla ed. The s udy was unded by he Finnish Pa ien
Insu ance Cen e .
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