Escolar Documentos
Profissional Documentos
Cultura Documentos
A study of the clinical incidence of infection in the use of banked allograft bone
WW Tomford, RJ Starkweather and MH Goldman J Bone Joint Surg Am. 1981;63:244-248.
This information is current as of September 27, 2007 Reprints and Permissions Click here to order reprints or request permission to use material from this article, or locate the article citation on jbjs.org and click on the [Reprints and Permissions] link. The Journal of Bone and Joint Surgery 20 Pickering Street, Needham, MA 02492-3157 www.jbjs.org
Publisher Information
Copyrtghl
981 by
The
Journal
of Bone
and
Joint
Surgery.
Incorporated
A Study
Incidence Allograft
AND Medic-al M. H.
of Infection Bone*
M.D., Bethesda, BETHESDA, Maryland MARYLAND Institute,
in the Use
BY W. W. TOMFORD, Frotn the M.D.t, Clinical R. J. Investigation
STARKWEATHER, Department.
GOLDMAN,
Research
ABSTRACT:
in grafting
567
To determine the incidence of infection procedures utilizing banked allograft bone, were sent to collaborating surgeons Tissue Bank freeze-dried allograft bone 1973 to October 1976. Three hundred were sufficiently completed Twenty-one patients were to re-
Materials
and
United States Navy Tissue Bank tissues from donors who meet the standard criteria lection reported previously . Bones collected conditions are cleaned ground bone, longitudinal and ters of all soft sections
as showing evidence were considered minor major according to the course. In eleven were positive cultures
ten there were
of infection, of which and nine were consideffect on the patients of the twenty-one paas proof of infection;
not. Analysis of the
then processed into pieces two to four cubic milhimein size. Cortical plates or strips are cut into fifteen-
remaining
proved
infections
showed
that
the
allograft
was
prob-
centimeter lengths. Long bones are left whole or are divided at mid-shaft. All tissue is stored in liquid-nitrogen freezers (- 196 degrees Celsius) to await results from aerobic and anaerobic touch cultures made of all deposits during procurement and processing. If cultures are negative, the tissue is freeze-dried and
10 per
ably not primarily responsible in most of the patients. Based on the data obtained in this study, the incidence of infection with the use of banked allogenous bone appears ported bone. Orthopaedic steadily increasing Tissue Bank, which surgeons lesions7 has noted that benign cystic unions3, allografts demand for allograft over the past several has attempted applications to fracture bone years. this has The been Navy from nonof to compare favorably with infection for orthopaedic procedures utilizing rates reautogenous
to less stored at
than room
of vapor evacuated
As
pressure bottles.
many as days.
in
pro-
cent
cessed
twenty-one
Bank either
are positive
after
cent
being
held
acnes
for
posior cent
Approximately
of the 10 per
tive
Corynebacterium remaining
Staphylococcus
epidermidis.
to meet
demand,
a positive
is considered
is irradiated.
In this
study,
fewer
than
these grafts has been an important part of the Tissue Banks role in the medical community, and studies of the physical and chemical suitability of the tissues have been initiated intermittently24. However, no determination of the incidence of infection following the use of processed and stored allograft bone has been performed. For this reason, a retrospective study of the results of grafting procedures tuted,
*
allografts required irradiation. These allografts were cultured after irradiation and all cultures were negative. Questionnaires were sent to 567 collaborating surgeons who used Navy Tissue Bank bone during the period
October 1973 to October 1976. The questionnaire con-
and en-
bone
was
insti-
Research
and
Dc-
with 303 of the 3 13 completed sufficiently to be used to compile data. No case was included that did not have at least an eighteen-month follow-up. The diagnoses, procedures performed, and types of grafts used in the 303 patients are listed in Tables I, II, and Results
Twenty-one (6.9 per course;
THE
velopment Command, Work Unit No. M0095-PN.00l.0003. The opinions or assertions contained herein are the private ones of the authors and are not to be construed as official or reflecting the views of the U.S. Navy Department or the naval service at large. 1 Department of Orthopaedic Surgery. Massachusetts General Hospital, Boston, Massachusetts 02 1 14. Wenatchee Valley Clinic, Wenatchee, Washington 98801. Division of Transplant Surgery, University of Virginia Medical Center, Richmond, Virginia 23298.
III,
respectively.
cent) the
of
the
303 282
AND
completed
questionnaires
tients postoperative
reported
evidence
of
remaining
OF BONE
infection
in the
reported
pano
244
JOURNAL
JOINT
SURGERY
CLINICAL
INCIDENCE
OF
INFECTION
IN
THE
USE
OF
BANKED
ALLOGRAFT
BONE
245
noted No none in three pato a in this intraveof the in in nine first ospa-
evidence infection
the patients
of this complication. Of necessity, evidence of was determined by the reporting surgeon because
could not be personally evaluated by us. Cases
heal tients
Wound
was
2, 4, and
chronic therapy, of
of these
of oral
reported
healing
as
such
infection
as
included
and
complications
delayed
of wound
the
wounddrainage
erythema
epithehialization responding
(with
alone.
or
without the
wound twenty-one
basis
drainage),
received
and
from
infection,
From groups
information on the
teomyelitis. into
on tients, of major most of was different in several these aspects group. (Cases
surgeons,
two
patients
of the effect
could
of the
be
divided
complication
the postoperative
course.
Cases
classified
as showing
eviproducthose
Diagnostically,
tumors
dence of minor infection ing little or no effect classified required These analyzed
The
malignant operated
in Tables
(Table IV),
I
IV and
in twelve
non-unions
infections
patients,
three prior
II
TABLE DIAGNOSES
TABLE
PROCEDURES
Lesion
No. of Patients
No. 229 49
replacement
I 17 19 6 14 1
25
III
No.
Malignant Benign Fibrous Fracture Spine fusion Mandibular Limb-length Congenital Realignment Osteonecrosis Osteopetrosis Iliac defect Sterile abscess reconstruction discrepancy pseudarthrosis osteotomy dysplasia
l6 48 27 20 18 4 4 3 2 I 1 1 1
Crushed Ground
Cortical
cortical cancellous
183 15 26 17 37
25
The (Case
two 13)
remaining and
patients
had
a unicameral of the
a congenital
pseudarthrosis
tibia
operated
(Case grafted
months Grafts
21). once
prior used
The with
unicameral
.
bone bone,
cyst
had
not
been
had
on previously
pseudarthrosis
been
nine
autogenous
unsuccessfully,
more corti-
to the in the
allograft. included
occurred chiefly in benign cysts or fusions. There seven benign bone cysts, two tumors (chondrosarcoma giant-cell tumor), one non-union after a lengthening tibia, one spine fusion for congenital scohiosis, maxillary osteotomy for maxillary reconstruction.
were and
cal bone
than
in the
first
group.
Each
of the
tumor
resec-
tions necessitated the use of a large piece of cortical bone and in three (Cases 14, 15, and 17) this type of graft was used exclusively. The operations for fracture non-union (Cases
pseudarthrosis
types of bone graft used included crushed or ground bone (Cases 1 through 8), a combination of crushed or cancelbus bone with cortical bone (Cases 9, 1 1 , and 12), and cortical bone alone (Case 10). Procedures in this group consisted (Cases
bloc
18,
19, bone
and
(Case
20) (Case
as
well
utilized
as
for grafted
the
congenital
bone. The
2 1) also
cortical
unicameral cortical
The
cyst
with
crushed
group inre-
and more
of the
corticocancellous
performed
mainly
of curettage
and
packing
of the
lesion volved
Three
procedures
the
second
1 through 8). One procedure (Case 9) utilized en excision of a large portion of bone, and the remaining
(Cases 10, 1 1 , and
extensive
tumor
surgery
resections
than
(Cases
in
14,
the
15,
first
and
group.
17)
three
onlay
grafts
for group
fuof not
complications IV).
2, FEBRUARY
quired extensive excision of both soft tissue and bone. The fracture non-unions (Cases 18, 19, and 20) required wide exposure because of previous infection. The tibial pseudarthrosis (Case 2 1 ) required extensive dissection to
(Table
NO.
Only
incision
4) did
246
W.
W.
TOMFORD,
R.
J.
STARKWEATHER,
TABLE IV
OF MINOR
AND
M.
H.
GOLDMAN
PATIEN
TS
WITH
EVIDENCE
INFECTION
Case
I
Procedure
Curettage Curettage and and pack pack Ground
Allograft
cancellous cortical
Complication
Localized erythema Drainage
Treatment
10
Result Wound
healed primarily
wound
at 4th day
Crushed
fibroma 3
4 5 6
7
Curettage
Curettage Curettage
and pack
and pack and pack
Crushed
Ground Crushed
cortical
cancellous cortical
Localized
erythema Drainage Localized erythema
Pos.
-
Not listed
-
Wound
10
Curettage
Curettage
and pack
and pack
Ground
Crushed
cancellous
cortical cortical
primarily
-
bone cyst
8 Giant-cell
erythema
Curettage
primarily
-
tumor
and pack
Crushed Femoral
Cortical
Localized
erythema 9
10
II
Chondrosarcoma
Non-union of limb-
condyle
strip
Drainage Localized
Yes
No
Pos.
-
Enterobacter species
-
10 days of oral
-
antibiot.
primarily primarily
lengthening Congen. Crouzons scoliosis syndrome Onlay Onlay graft graft Rib matchsticks, crushed conical Rib segment. ilium strip
No Yes
12
wound
allow
placement
of
the
nine-centimeter
fibular-shaft
when
aureus. evidence of
nine
patients
in
the
second
group
had
wound
postoperatively, and each had of the drainage was not described surgeons. Of nine cultures, three
a culture. The by any of the (Cases 14, 17, six cultures in three of
healing antibiotic
the
infection
cleared
with
Twenty-one
patients
with
evidence
of infection
out
of
these (Cases 16, 18, and 20), but the other three grew either Staphylococcus epidermidis (Case 13) or Staphylococcus auerus (Case 21), or both (Case 15). Antibiotics were used in the treatment of five patients (Cases 15, 16, 18, 20, and 21). Complications dence of major ensued in all patients showing eviinfection that were not noted in patients
303
surgical
procedures
employing
banked
bone
ahlografts
of infection.
No other
studies
the
of
of clinical infection following have been reported. Cruse reported in 372 patients and a 3.9 per
site in 986 patients
use of an infec-
after cent
infection
showing evidence of minor infection. The unicameral bone cyst (Case 13) drained for six months and then cleared without antibiotic therapy. In each of the patients with tumors , drainage developed during the postoperative course. One patient (Case 14) had drainage for six months and union was delayed. One patient (Case 17) began to have drainage at one separated at two weeks, weeks. The graft was week postoperatively; the wound and the graft was removed at three removed in another patient with a (Case 15) after a before one, one at The for ancul-
The
with
6.9
per cent
report,
infection
implies
rate
that the
in our study,
risk
compared
with
Cruses
of infection
bone However,
is approximately many
surgeons
double complications
that
with re-
bone.
by the
of the
responding
as evidence
of infection
erythema,
delayed
epithelialization,
and These
tumor (Case 16) after one week, and in another drainage developed eight months postoperatively, prolonged course of irradiation and chemotherapy and after surgery. Of the three allograft (Case 18) was removed four months third fracture several tibiotics. (Case (Case 20), non-union fracture at two
both secondary to reinfection. (Case 19) drained minimally the infection cleared without with a congenital pseudarthrosis shortly after surgery, but
bacterial contamination. Therefore, the incidence based on all reported infections may not accurately reflect the true risk of infection. The evidence in each case must be exammed to determine if an infection proved by bacterial contamination occurred, and if the allograft can be implicated as the source of the contamination.
Eleven patients had a positive culture: five with evi-
dence major
of a minor infection and six with evidence of infection. For four of the five with positive cultures
in the former
group
(Cases
I , 2, 4, and
OF BONE
THE JOURNAL
CLINICAL
INCIDENCE
OF
INFECTION
IN
TABLE
THE
V
OF
USE
OF
BANKED
ALLOGRAFT
BONE
247
PATIENTS
WITH
EvID ENCE
AJOR
INFEcrIoN
Case
Diagnosis
Procedure
Allograft
Complication Drainage
Cultured Yes
Result Pos.
Organism
13
14
Curettage
Whole
and pack
bone
Staph.
epidermidis
of tibia
10 cm of femur 12 cm
Drainage
Yes
Neg.
No growth
for 6 mos.,
cleared;
of shaft
15 Osteogenic sarcoma Whole bone Distal end including Drainage at 8 mos. Yes Pos.
union
of shaft 16 17
18
epidermidis
Drainage at 4th day Yes
union
Giant-cell Osteogenic
sarcoma
tumor
Curettage Whole
Onlay
Cortical
Pos. Neg.
Pos.
10 days
;
of
Mid-femoral
Drainage
wound
at 7th day;
separation
Yes
Yes
removed
removed
at 3 wks.
at 2 wks.;
no antibiot. 10 days of
Fracture
graft
non-union 19 Fracture
non-union
Drainage
at 5th day
Wound
oral antibiot. Drainage at 10th day Yes Neg. No growth Dry dressing, no antibiot.
Onlay
graft
Conical
plate
for
months,
then cleared 20
21
Fracture non-union
Congen.
Onlay Onlay
graft graft
Conical Fibular
plate shaft
Drainage Drainage
Yes Yes
Pos. Pos.
Graft removed
antibiot.
at 4 mos. antibiot.
6 wks.
of IV
Wound
Aseptic
healed secondarily
drainage
tibial pseudarthrosis
10 days of oral
of these four patients was treated fifth patient (Case 9) the organism required
For the 18, the was (Cases ten wound patients (Cases 3, erythema and three used. 13, from 16, of
with was as
of was three a
the
the
tissue.
tissue,
In addition,
the Navy surgeon eleven culture patients (Case culture tissue from irradiated. by may the the the The final have glass culture
as a final
Tissue Bank the with 13) used was in that contaminating touch been storage (or even preoperatively
check
recommends
on the
immediately postoperative to show
sterility
that the prior
of
col-
and
positive
the
patient
cultures (Cases in each treatment group
incision
three group 20), the For the of with
and
the
drainage
six patients evidence organism was removed
laborating to implantation. Of tures, organism Culture to was been or the the removal not shipment missed tissue
antibiotic infection
treatment.
the graft
only
one on
listed, antibiotic
but in this
postoperatively. was negative and the may Tissue at the The was
remaining
of the
patients
the organism
positive 10, drainage. and cul1 1) No
Navy
Tissue culture
Bank, at the
was
tures. were
listed.
The noted remaining patients to have Seven
organism
5 through
without
from
culture was grown and no antibiotics were used in any of these patients. All wounds healed primarily. The three remaining patients (Cases 14, 17, and 19) had negative cultures. none Each were drainage an organism. of treated these wih had drainage antibiotics. from In the Cases wound, 14 and but 19, never sev-
preoperative
performed)
were
with tion had
not
positive Of the who
reported
cultures. five
for
patients
any
of the
ten
evidence
remaining
of minor (Cases no incisions evidence
patients
infechealed of os-
had
a positive drainage.
2, 4, and 9)
drainage
The grew
continued
fluid
for
was
several
cultured 17,
months
the wound
and
then
but separated
cleared.
postoperative however,
periodically
primarily,
In Case from
teomyelitis
other erythema two
at any
patients was listed
time
in the postoperative
course.
1 and infection. 12),
For
the
eral
not
days
cultured.
postoperatively
Material
the
the
graft
wound
was
was
removed
negative
but
on
in this as the
,
wound In each
and
A positive
the
wound the
wound
without
does not
further
provide
comphicaevidence
without
of antibiotics.
of these superficial
taminated Ofthe of The but two after major
the reported information suggested a that was unlikely to be due to a conthis than had cannot Case positive be proved. evidence two (Cases 13) showing cultures,
of the infection. Factors apart from allograft such as extensive surgical dissection, exinstruments or to bacterial conthe role of the
wound infection is
cessive operative time, or contaminated personnel may produce or contribute tamination. One method of evaluating
-
18 and
20)
were
known
been thatthe
to have
had
a previous
for the infection
infection.
reinfection, recurred. months
15)
In
allograft
in the
event
of a postoperative
only
at
several (Case
to culture cessing
are
VOL.
the
just
NO.
allograft
prior
prior
In the touch
vacuum-packing
pro-
procedure.
of them
an
of tissues
at the Navy
cultures
grown
63-A,
to freeze-drying
1981
infected draining sinus developed after eight chemotherapy. The graft cannot be eliminated
months of as a source
2. FEBRUARY
248
W.
W.
TOMFORD,
R.
J.
STARKWEATHER,
AND
M.
H.
GOLDMAN
of infection in that patient, but the suppressive effect of chemotherapy on the immune system should be considered as a factor in the etiology of the infected drainage. The second patient (Case 2 1) had aseptic drainage from the surgical site for six months before the cultures became positive. Although impossible to prove, this suggests that the drainage became infected from an exogenous source rather than from the graft. In the remaining patient in this group (Case 16), the allograft was removed at one week, the patient was treated with antibiotics, and the wound healed satisfactorily. No report was available on a culture of the Of allograft before or after surgery. all the cases analyzed, the graft appears to be a strong candidate for the source of infection in only one patient (Case 13). In one additional patient (Case 16) the graft was a possible source, although reports of cultures before surgery were not available. Information provided for the other nine patients not have been a primary analysis cannot be interpreted suggested factor that the allograft in the infection. the innocence may This of
these factors are important in any patient undergoing the implantation measures would patients of infection of a large seem to be reported varies as ac-
surgery. When combined with piece of dead bone, preventive particularly In this having
an infection,
cording to which cases are included only patients in whom the ahlograft fore less
and after the procedure are included, the incidence is than I per cent. If only patients with proved post-
operative infection are included, the incidence is 3.6 per cent. If all patients who were reported to have an infection are included, the incidence is 6.9 per cent. Perhaps the best interpretation of the data is that the incidence does not appear to be greater than 7 per cent and probably is lower. The advantages creased operative and complications with a second eration. The of the use of a banked allograft time and avoidance of postoperative such operative individual as bleeding site surgeon or infection still are together worthy with
-
depain
as proving
the grafts, but it does emphasize the necessity for careful surgical techniques and prophylactic measures when employing an ahlograft. The use of preoperative antibiotics, for example, which was not examined in this study, might be a valuable adjunct. Many of these procedures involve extensive dissection for tumors, or d#{233}bridement with pre-
must decide if the risk of using able. We hope that this study easier.
NoTE: The authors wish to thank Mr. Vernon
Gambttl
asststance
in the
study.
References
I. 2.
3. 4. 5. Soc., 3: 21 1 . 1978. lncidence of Wound Infection on the Surgical Services. Surg. Clin. North America. 55: 1269-1275. 1975. FRIEDLAENDER. G. E.; STRONG, D. M.; and SELL, K. W.: Studies on the Antigenicity ofBone. I. Freeze-Dried and Deep-Frozen Bone Allografts in Rabbits. J. Bone and Joint Surg. , 58-A: 854-858, Sept. 1976. MCMASTER, P. E.. and HOHL, MASON: Tibiofibular Cross-Peg Grafting. J. Bone and Joint Surg., 57-A: 720-721, July 1975. MANKIN. H. J.; FOGELSON, R. S.; THRASHER. A. Z.; and JAFFER. FAROOQ: Massive Resection and Allograft Transplantation in the Treatment of Malignant Bone Tumors. New England J. Med., 294: 1247-1255, 1976. SPENCE. K. F.. JR.; SELL. K. W.; and BROWN, R. H.: Treatment of Unicameral Bone Cyst with Freeze-Dried Cancellous Bone Allograft. In Proceedings of The American Academy of Orthopaedic Surgeons. J. Bone and Joint Surg.. 50-A: 841-842. June 1968. A. Cortical Bone.
CRUSE.
BRIGHT. BRIGHT.
R. R.
W.: W.,
Proc., Preserved
S (Supplement
P. J.
E.:
6. 7.
THE
JOURNAL
OF BONE
AND
JOINT
SURGERY