LOOSENING OF THE FEMORAL COMPONENT AFTER TOTAL HIP

REPLACEMENT

THE THIN BLACK LINE AND THE SINKING HIP

MARK PATERSON, PHILIP FULFORD. ROBIN DENHAM

Froni Queen A lexandra Hospital, Portsmouth

Review of the radiographs of 882 consecutive metal-to-polyethylene hip replacements after a mean
follow-up of 6.8 years showed 72 cases (8%) of aseptic femoral loosening, all of which showed a lucent zone
or black line between metal and cement. In 97% of the series this appeared within two years of the
arthroplasty. Progress of loosening was unpredictable and only 24% had significant symptoms. Improved
technique with methylmethacrylate cement in Stanmore prostheses had reduced loosening after two years
from 7.9% to 0.4%. Methods of detection of early loosening are discussed.

Total hip replacement is one of the most successful and seen adjacent to the superolateral curve ofthe stem of the
rewarding operations ever developed. It provides good femoral prosthesis on an anteroposterior radiograph
early results in over 90#{176}/of cases and most of these will (Fig. I). A number of papers discuss the radiographic
last for 7 to 10 years (Dobbs 1980). The most common changes and their significance, but no large comprehen-
cause of late failure is loosening of the femoral compo- sive series with reasonable follow-up has been reported
nent (Harris, McCarthy and O’Neill 1982). from one surgeon using consistent methods. We have
A number ofpapers describe series ofcases in which examined the records and radiographs of a consecutive
loosening of the femoral component had occurred. The series of 882 metal-to-polyethylene hip replacements, all
reported incidence ranges from I I % (Harris
. et a!. 1982) performed by one surgeon (RAD). Follow-up of this
to 36% (Carlsson and Gentz 1980) or even 50% at 5.8 series is from 3 to I I years (mean 6.8 years) and there has
years (Ling ci ii!. 1981 ). Most of this large variation been excellent co-operation from the patients, with over
stems from diflering radiological and clinical definitions 95% attending for their six-year review.
of loosening and varied length of follow-up, but there are A narrow lucent zone or “black line” between metal
also real differences related to the wide range of prosthe- and barium-loaded cement was seen in one or more
ses and the techniques of insertion. A number of radio- radiographs of 72 of these patients. Their case histories
logical features of the usually painless early loosening of and the full series of their films were then studied in
the femoral component have been described. These detail. An attempt was made to determine the natural
include fractures in the cement (Weber and Charnley history of these black lines and any other associated
1975), subsidence ofthe prosthesis (Gruen, McNiece and changes. The lines were almost invariably symptomless
Amstutz 1979), and the appearance of radiolucent lines when first seen, and it was possible to review factors
or zones at the interface of cement and metal (Carlsson which might influence the incidence both of radiographic
and Gentz 1980). changes and of symptoms.
It is agreed by most authors that a radiolucent line
or zone between radio-opaque cement and the stem of METHODS AND MATERIALS
the prosthesis is a useful early sign which will be present A total of 882 total hip replacements were performed
in all or most cases ofmechanical loosening. It is usually consecutively between 1974 and 1982 by RAD at Lord
Mayor Treloar Hospital, Alton, and Queen Alexandra
Hospital, Portsmouth. All operations were by a standard
J. M. H. Paterson. FRCS. SeniorOrthopaedic Registrar posterolateral approach without osteotomy of the
The London Hospital, Whitechapel. London El IBB. England.
P. C. Fulford, (‘J’O. OBE, MChOrth, FRCS. Orthopaedic Surgeon
greater trochanter.
3 Bankside, Alverstoke, Gosport. Hampshire P012 2NH. England. Operation. The femoral component was cemented, and
R. A. Denham, FRCS. FRCSEd, Consultant Orthopaedic Surgeon from 1974 to 1979 40g of barium-loaded CMW cement
Queen Alexandra Hospital, Cosham, Portsmouth, Hampshire P06
3LY. England. was inserted by “thumbing” into a cavity prepared with
Requests for reprints should he sent to Mr J. M. H. Paterson. rasps.
( . 1986 British Editorial Society of Bone and Joint Surgery From 1980 to 1982 the femur was more thoroughly
0301 620X 86 3047 S2.00
prepared, with a meticulous routine in which the use of

392 THE JOURNAL OF BONE AND JOINT SURGERY

 LOOSENING OF THE FEMORAL COMPONENT AFTER TOTAL HIP REPLACEMENT 393

films were studied as they became available, to confIrm

the diagnosis and to assess any changes. Thirteen hips
which had suffered gross loosening secondary to deep
infection (I .5% of882) were excluded from the series.
The lucent zone. The radiographs of the 72 hips which
showed a black line were studied in detail, and the size of
the radiolucent zone in each film was measured vertically
in the line of the medial border of the stem of the pros-
thesis (Fig. 2). A transparent scale and a hand lens were
used and the results were repeatable by different
observers and at different times. The direction of this
measurement. while magnifying the shortest interval
between metal and cement, approximates to the pre-
sumed direction of subsidence of the prosthesis and
increases the sensitivity ofthe result. It should be empha-
sised that this measurement is not the more usual
“width” of the lucent zone. In no series of films did this
measurement decrease with time. Differences in radio-
graphic magnification were assessed by measuring the
apparent length ofthe whole metal component in each of
Fig. I Fig. 2 a series of films. Where there were large differences in the
Figure 1 Radiograph to show radiological loosening of a Stanmore size of this image, an adjustment was made in the
prosthesis 1 sears after operation. The lucent zone or “black line” is
seen between the cement and the superolateral part ofthe femoral com- measurement of lucent zones greater than 2 mm. Magni-
ponent stern. Figure 2--Diagram to show the measurement of the fication of the image was also checked on a number of
lucent zone in the line ofthe medial border ofthe stem ofthe prosthesis.
films by comparing the known diameter of the prosthetic
head with the diameter of its image on the radiographs.
rasps and curettes was followed by a “scrub-squirt-suck” Subsidence. An effort was made to detect and record any
technique to clean the remaining coarse cancellous lining subsidence of the metal prosthesis in relation to the hone
of the hone (Halawa ci a!. 1978: Lee and Ling 1981; of the femur itself. Subsidence was obvious in all the
Krause. Krug and Miller 1982). Hydrogen peroxide was cases of severe loosening. but attempts to measure this
used to improve cleaning and secure better haemostasis accurately failed to provide repeatable results.
(Hankin ci a!. 1984). A plastic cement excluder of the
Hardinge pattern was placed in the medullary cavity
which was then carefully dried before being filled with
SOg ofCMW cement from a gun. This cement mass was
pressurised manually and the stem of the femoral pros-
thesis thrust fIrmly into the cement mass after early poly-
nierisation had produced an increase in viscosity. Care
was taken to ensure that the prosthesis then remained
absolutely still until the cement had hardened completely
after 9 to 10 minutes.
In the early part of the period being reported, a
Charnley prosthesis was used in 164 hips; later.
Stanmore prostheses were used in 718 hips. Since this
series ended in 1982, a new Denham femoral component
has been used.
Routine review. All patients were reviewed clinically and
radiographically six months after operation and then at
one year. two years. and every two years thereafter. The
anteroposterior films taken within a few days of opera-
tion and at each review appointment were specially filed
so that the full sequence of radiographs for each hip Fig. 3 Fig. 4
could he displayed together. and at each review a search Radiographs at 21 years and M years after a Stanmore hip replacement
to show the difficulties of measuring subsidence against bony land-
was made f’r the presence of a black line between metal
marks. In this very obvious case. despite definite loosening. the pros-
and cement at their superolateral junction. The appear- thesis has apparently risen in relation to a line drawn from the top of
the greater trochanter at 90 tO the shaft of the femur. The differing
ance of even a very narrow lucency was noted and pre-
magnification. a flexed position and sonic rotation (evidenced by the
vious radiographs were then re-examined. Subsequent lesser trochanter) have all contributed to the optical illusion.

VOl 68 B. No 3. \1\’i 1956

394 J. M. H. PATERSON, P. C. FULFORD, R. A. DENHAM

RESULTS

Lucent zones. Not one of the 72 hips showed a lucent

zone or black line in the film taken within a few days of
operation. The black lines seen in later review radio-
graphs varied from 0.5 mm to I 7 mm in vertical size
(mean 3.3 mm). The rate of increase of these lines varied
from zero to 3 mm per year (mean 0.6 mm per year). This
change was far from uniform, and the rate of increase
-
could alter dramatically either way. Figure 5 illustrates
this apparently unpredictable variation between stability
and deterioration. With reference to the clinical symp-
toms, it was interesting to note that in 7 ofthe 12 patients
who had already had revision operations the radio-
time after operation (years) graphic luccnt zone had been under 2 rum in vertical size

Fig. S
at the two-year follow-up.
Time since arthroplasty. The first appearance of a black
Diagram relating the width of the lucent zone to the time after opera-
tion: records of 72 cases superimposed. Group A show rapid early line was related to the time since arthroplasty (Fig. 6).
progression and have all undergone reision. Group B have small.
Almost one-third of the series had shown a black line at
sloss I progressive OF temporarily stationary Iuccnt zones. and few
have sn1pton1s. the first review only six months after operation. This line
was usually very narrow, and nearly always symptom-
There were four main reasons for this. First, as men-
less. Two years after insertion of the prosthesis, no less
tioned above, there was variable magnification of the than 97% of the cases in this series had declared them-
radiographic image. although this could be corrected by
selves: only two of the 72 sinking hips first showed a
reference to the known diameter of the head. Second,
black line later than two years after operation.
variation in femoral rotation was found to alter signifi-
Pain and loosening. The onset of pain was nearly always
cantly the radiographic relationship between “fixed” considerably delayed in relation to the early radiographic
points on the femur and the edges of the image of the
signs of loosening. The onset of pain is related to time in
prosthesis (Figs 3 and 4). Third. difference in radio-
years in Figure 6. which shows that only 17 hips (23.6%
graphic projection altered the relationship between pos-
sible points for measurement. A film centred to show
“pelvis for both hips” gave different results from one
centred over one hip. Finally, efforts to find a satisfac-
tory point on the bone ofthe upper femur from which to
vi
measure subsidence failed to produce repeatable results.
Too often the tip of the greater trochanter was indistinct
or obscured by heterotopic bone. while the contours of
the lesser trochanter were influenced too much by the
degree of rotation of the femur.
It was reluctantly concluded that accurate, reliable and
repeatable measurements of subsidence would be pos-
sible only from radiographs taken prospectively with
standard positions and projections, or by the use of a
radio-opaque marker placed in the femoral bone at the time after operation (years)

time ofthe operation. Fig. 6

Other features of loosening. Careful examination was Diagram relating the first radiological sign of loosening and
the onset ofsymptoms to the time since operation. Note that
made of each set of films to detect other progressive 970/0 of cases had a lucent zone or black line by two years,

changes. and especially any fractures in the cement. and that only 24#{176}/a
of patients have, as yet. developed
symptoms.
Lucencies developing between cement and bone were
noted, as were any indications ofvarus or valgus angula- of those with lucent zones) have, as yet, developed symp-
tion ofthe stem. toms. Pain correlates well with both the size ofthe lucent
Records. The clinical records and Wessex computer cards zone (Table I) and with the rate of increase in size of the
for all 72 patients were examined to confirm the details of lucent zone (Fig. 7). Thus, no patient among 50 in whom
operative technique and the onset, severity and course of the lucent zone was less than 4 mm had yet experienced
symptoms which might be referable to loosening. Note significant pain, while only 5 of the 22 patients with a
was made of patients who were awaiting, or had already lucent zone larger than 4 mm were pain-free. Similarly, no
undergone. revision arthroplasty for pain attributable to patient among 43 in whom the lucent zone had increased
loosening. at an average of 0.4 mm per year or less had yet experi-

THE JOURNAL OF BONE ANt) JOINT SURGERY

 L(X)SENING OF THE FEMORAL COMPONENT AFTER TOTAL HIP REPLACEMENT 395

Table I. The number of patients with and Table II. The position of the prosthesis related to the width of the
without pain related to width of the lucent lucent zone. rate ofdeterioration and presence of pain
zone

Position of prosthesis
Width oflucent ione Pain-free Painful Varus
Neutral
Less than 4 illiTi 50 0 (n = 62) (n=9)

4 5 iim 3 Mean width of lucent zone (i;im) 2.9 5.8

6 7 iim I 7 Mean rate ofincrease (mmir) 0.54 1.01

8 iim and over 1 8 Number(#{176}/o)withpain I3(2/%) 4(44%)

Total 55 17

enced pain. while only 12 out of29 patients with rates of graphs was there any evidence of movement of the tn-
increase greater than 0.4 mm per year were pain-free. angular block of cement which forms the superolateral
Fwelve patients have so far had revision arthro- boundary of the lucent zone, nor any significant lucency
plastics for painful hips, though others will require this at its interface with the bone inside the greater tro-
soon. All had black lines within two years, but four of chanter. The commonest mode of failure was a fracture
them did not develop significant symptoms until eight of the mid-zone cement, with slowly progressive sinking
\cars af’ter arthroplasty. The mean size ofthe lucent ZOne ofthe metal prosthesis and the distal cement mass, which
was I .8 mm in pain-free hips. and 8.2 mm in those with was itself sometimes fractured. This is a combination of’
significant pain. the modes offailure Ia and lb ofGruen ci a!. (1979), that
is, both pistoning of the metal stem within some of the
28 pain-free cement and movement of the remaining cement and stem
24
vi
U painful within bone. Movement away from the fixed supero-
QJ
vi
20 lateral triangle ofcement was the cause ofthe lucent zone
16 or black line. Failure to see a fracture in the cement in
12 three-quarters of the cases was probably because, while
8 the fracture could be in any plane. it would be clearly
-
4 revealed only when this plane coincided with the dinec-
0 tion ofthe x-ray beam.
02 04 6 08 10 12 14 16 18 20 22 24 26 28 30
Attitude of the prosthesis. The alignment of the prosthesis
rate of increase of lucent zone (mm/year)
in relation to the femoral shaft in the first film was neu-
Fig. 7 tral in 62 cases, varus in nine cases and valgus in only
I)iagrani relate the rate ofincrease ofthc lucent zone to the presence
tO
one. The radiographs of 72 randomly selected unloo-
of pain.
sened hip replacements showed much the same distnibu-
Fractures of the cement. Definite fractures, other than the tion of alignment. However, the loose prostheses which
lucent zone. could be seen in the radio-opaque cement in were in a varus position from the beginning had devel-
only 19 hips. 26% of the series. These transverse black oped a wider lucent zone that the others at the time of re-
lines were seen most often around the middle third of the view (5.8mm as against 2.9mm) and also had a higher
stem of the prosthesis. In seven of these cases the fracture incidence of pain and a more rapid rate of deterioration
was seen to widen as the lucent zone increased in width, (Table II). The significance of this is uncertain since the
confirming. in these cases at least, that while the proxi- widening ofthe zone is probably a product ofboth subsi-
mal cement did not move, the distal cement subsided dence and increasing medial drift or varus displacement
with the metal stem. These fractures were usually seen in ofthe prosthesis (Carlsson and Gentz 1980).
association with the larger lucent zones. though this was Type of prosthesis. Although fewer in total number,
not always the case. No fracture was visible in six hips Charnley prostheses had been used in exactly half the
which showed lucent zones larger than 6 mm. cases that developed black lines (Table III). Thus, the
In none of the 72 sets of anteroposterior radio- Charnley femoral component became loose in 22.8% of
Table Ill. The number ofCharnley and Stanmore prostheses inserted in each year ofthe period under review, and the number

of those which subsequently demonstrated radiological signs of loosening

1974 1975 1976 1977 1978 1979 1980 1981 1982 Total

(‘ham/er pro.st/1(’.se.s
Number of hips 10 98 42 3 I 0 4 0 0 158
Number with lucent zones I 26 8 1 0 0 0 0 0 36

.Staii,,iorc J)ro.st/ie.se.s’
Number of hips 94 12 50 110 94 88 114 106 43 711
Number with lucent zones 6 2 4 4 11 8 1 0 0 36

VOl 68 B. No 3. MAY 986

396 J. M. H. PATERSON, P. C. FULFORD, R. A. DENHAM

cases compared with 5. 1 % of the Stanmore prostheses.

As Illost of the Charnley prostheses were inserted during
the first three years ofthe study. it might be expected that
later technical iniprovements unrelated to prosthesis
design were responsible fcr the different incidence of
loosening of these two prostheses. However, Table III
shows that Stanmore prostheses inserted during these
early years were less likely to loosen than the Charnley
prostheses.
\ear of operation. The number of arthroplasties which
developed a black line varied greatly from year to year
(Table Ill). In the earlier years of the study, particularly
1975. this was probably a reflection of the relatively poor
results with the Charnley prosthesis. However, from
1977 onwards, diflerences in the incidence ofblack lines
cannot he attributed to the design of the prosthesis since
only 8 out of 563 arthroplasties were of the Charnley
pattern.
A striking decrease in the incidence of loosening
occurred from 1980 onwards. Twenty-three of 292
Stanmore arthroplasties (7.9#{176}/o)
performed from 1977 to
Fig. 8
1979 had a black line at two years; only one of 263 Radiograph of a Denham
Stanmore arthroplasties (0.4#{176}/o)
showed this feature two straight-stem replacement with a
metal marker in the hone of the
years after operation performed from 1980 to 1982. This femur.
dramatic change coincides with the introduction of
improved methods of cementing.
the upper femoral shaft. Weber and Charnley present
DISCUSSION diagrams to show improved support after movement of
The appearance of a black line between a fixed supero- the distal cement mass with its metal stem; Ling’s Exeter
lateral triangle of radio-opaque cement and a curved prosthesis was designed to re-stahilise after minor subsi-
femoral stern seems to he a useful sign ofearly loosening. dence. This concept has not been supported by this series
It is commonly symptomless. hut as a warning sign itjus- of 72 hips with radiographic loosening. The rate of
titles special follow-up. ifonly to ensure that revision can widening of the lucent zone was unpredictable and very
he considered before there is serious loss of bone stock. variable. There were several cases in which a narrow
The routine use of radio-opaque cement and review with black line, recognised within a year of arthroplasty and
radiography at two years may be important in this stable for a number of years, then deteriorated quite
respect. and this is strongly advised. rapidly and became painful. Coventry (1981) found a
Unfortunately. this sign is absent when cement is plateau ofloosening between 5 and 10 years. Follow-up
radiolucent, and more importantly. when a straight-stem in this series is not yet long enough to be certain whether
prosthesis is used. Under those circumstances. a direct or not this is the case, but Figure 5 suggests that deteni-
measurement of any subsidence of the prosthesis in rela- oration is unpredictable even after five years.
tion to bone would be useful. In our series this could not, The relationship between lucent zones and symp-
in retrospect. be accurately measured. Clarke ci a!. toms is very similar to that reported elsewhere. Ofour 72
(1976a,b) reported similar difficulties in assessing the patients with black lines, 76% remained symptom-free at
wear of acetahular components and devised special jigs mean follow-up of 6.8 years. paralleling the 79%
to ensure that films were centred accurately. Care with reported by DeSmet. Kramer and Mantel (1977) and the
radiographic projection will help. but it seems best to 77% of Carlsson and Gentz (1980). Of hips with lucent
mark the hone at the greater trochanter with a small zones of4mm or more, 77% were painful: Beckenbaugh
metal slug (Fig. 8). A special introducer has been and Ilstnup (1978) reported 56% with symptoms. and
designed which adds only a few seconds to operating Carlsson and Gentz ( I 980) reported 50% for subsidences
time: any movement of the prosthesis will then be easily of this degree.
detected by comparison of standard single-hip films The most striking feature of this study has been the
taken at intervals after the operation. dramatic reduction in early radiographic loosening
It has been suggested (Weber and Charnley 1975; which has followed the use of improved techniques of
Ling ci a!. 1981) that a suitably designed femoral pros- cementing. With the older methods, black lines, if they
thesis can subside with part of its damaged cement were to appear. had usually become evident by two
mantle to a new position ofstahility within the funnel of years. Since the new techniques have been used, only one

THE JOt!RNAL OF BONE AND JOINT SURGERY