VOL. 57-B, No. 1, FEBRUARY 1975 13

RESULTS OF TREATMENT OF SPINAL TUBERCULOSIS BY

“MIDDLE-PATH” REGIME

S. M. TULI, VARANASI, INDIA

From the Department of Orthopaedics, Institute of Medical Sciences,

Banaras Hindu University, Varanasi

The efficacy of modern drugs in the treatment of tuberculosis of the spine has been evaluated by a

personal follow-up for three to ten years. Operation on the vertebral lesion was done only for those patients

with or without neural complications who failed to respond favourably to drug therapy and rest. Thus absolute

indications for operation were present in only 6 per cent of cases without neural involvement and in 60 per cent

of patients with neural deficit. Of the patients who responded to drug therapy alone, only 19 per cent revealed

increase of kyphosis by more than 10 degrees. The diseased area showed radiological evidence of osseous

replacement in 296 per cent of cases, of fibro-osseous union in 50 per cent and of fibrous replacement in

202 per cent. The overall results of this regime compare favourably with those of radical operation. It is

suggested that freatment should in the first place be by modern antitubercular drugs.

At present two divergent philosophies ofthe manage-

ment oftuberculosis ofthe spine are prevalent. A number

of surgeons (Wilkinson 1950, 1969 ; Orell 195 1 ; Fell#{228}nder

1955 ; Kondo and Yamada 1957 ; Hodgson, Stock, Fang

and Ong 1960; Bailey, Gabriel, Hodgson and Shin 1972)

practise surgical extirpation of every vertebral lesion.

Another approach (Konstam and Konstam 1958 ; Kaplan

1959; Konstam and Blesovsky 1962; Stevenson and Man-

ning 1962 ; Friedman 1966) claims impressive results from

the treatment of such patients primarily by antitubercular

drugs and rest alone. We have termed our policy of

treatment the “middle-path” regime because we do not

practice universal surgical extirpation nor do we advocate

an absolutely conservative approach (Tuli, Srivastava,

Varma and Sinha 1967; Tuli 1969; Tuli and Kumar 1971).

We have been treating our patients mostly on non-

operative lines with antituberculous chemotherapy, rest

and spinal braces. Hospitalisation has been restricted to

the paraplegics who were unable to walk, or to patients

who required evacuation of abscesses or d#{233}bridement of

vertebral lesions or those who accepted fusion of the spine

for an unstable and painful lesion.

THE “MIDDLE-PATH” REGIME

The “middle-path” regime is carried out on the following

lines.

Rest-Rest on a hard bed or plaster bed is enforced. A

plaster bed is necessary only for a minority of patients

or children who do not realise the value of rest. In the

treatment of cervical and cervico-thoracic lesions, trac-

tion was used in the early stages to put the diseased part

at rest.

Drugs-For an adult, streptomycin one gram by intra-

muscular injection daily is used for about three months.

Sodium para-aminosalicylate 12 grams daily in divided

doses is given for eighteen months; and isoniazid 300

milligrams daily in divided doses for about twenty-four

months. Supportive therapy includes multivitamins,

haematinics if necessary and a high protein diet. Doses

are modified according to age. No significant complica-

tions of this triple drug regime have been observed. We

feel that when the tuberculosis is active the patient is able

to tolerate this relatively high dose.

More recently we have been using a combination of

isoniazid (300 milligrams) and thiacetazone (150 milli-

grams) in some cases instead of isoniazid and sodium

para-aminosalicylate, primarily for economic reasons.

When resistance to first line antitubercular drugs is appar-

ent it is necessary to change to newer drugs. Preliminary

observations suggest that in the near future sodium para-

aminosalicylate may be replaced by one of the newer

drugs such as ethambutol or rifampicin. The average

daily dose of ethambutol is 25 milligrams per kilogram

for the first sixty days, to be followed by I 5 milligrams

per kilogram for a total period of about two years.

Supervision-Radiographs and erythrocyte sedimentation

rates are done and patients are called for check up at three

to six months’ intervals. Kyphosis is measured radio-

logically (Dickson 1967).

Resumption of activity-Gradual mobilisation of the

patient is encouraged with the help of spinal braces after

six to nine months of bed rest, depending upon the

progress of healing. A spinal brace is continued for about

eighteen months to two years, when it is gradually dis-

carded.

Abscesses-Abscesses near the surface are aspirated and

one gram of streptomycin in solution is instilled at each

aspiration. Open drainage of the abscess is performed if

aspiration fails to clear it. Not all radiologically visible

Professor S. M. Tuli, MS., PH.D., F.A.M.S. ,Head, Department of Orthopaedics, Institute of Medical Sciences, Banaras Hindu University,Varanasi, 221005, India.

14 S. M. TULI

THE JOURNAL OF BONE AND JOINT SURGERY

paravertebral abscesses were drained ; drainage was mci-

dental when decompression was performed for paraplegia

or when d#{233}bridement was performed for active tuber-

culosis. Prevertebral abscesses in the cervical region have

been drained under local or general anaesthesia when

complicated by difficulty in swallowing or breathing.

Drainage of a paravertebral abscess was considered when

its radiological size increased in spite of the treatment.

Sinuses-In most cases sinuses healed within six to twelve

weeks of the start of the treatment. A small number

required longer treatment or excision of the tract with or

without d#{233}bridement.

Neurological complications-In the patients who began to

show progressive recovery of neurological complications

on triple drug therapy between three to four weeks and

who progressed to complete recovery, surgical decom-

pression was considered unnecessary. Decompression of

the cord for neurological complication has been per-

formed for patients who did not show progressive re-

covery after a fair trial of conservative therapy for a few

weeks, for patients who developed neurological complica-

tions during conservative treatment, for those who showed

deterioration of the neurological state while undergoing

treatment with antitubercular drugs and bed rest, and for

those with a history of recurrence of neurological compli-

cation. In advanced cases with motor, sensory and

sphincter involvement or those having severe flexor

spasms, as well as in elderly patients, decompression was

not delayed unduly. In other words we performed decom-

pression for absolute indications (Tuli 1969).

Excision-Excisional surgery is recommended for pos-

tenor spinal disease with or without neural involvement

because of the danger of development of superficial ab-

scesses or sinuses and secondary infection ofthe meninges.

D#{233}bridement-Operative d#{233}bridement is advised for

patients who do not show arrest of the activity of spinal

lesions after three to six months of chemotherapeutic

regime, or for patients with recurrence of the disease.

TABLE I

INDICATIONS FOR OPERATION ON THE VERTEBRAL LESION

Decompression for neurological complications which failed

to respond to conservative therapy.

Posterior spinal lesion.

Failure ofresponse after three to six months of non-operativetreatment.

Doubtful diagnosis.

Instability after healing.

Recurrence of disease or of neural complication.

Fusion-Posterior spinal arthrodesis is recommended for

unstable spinal lesions in which the disease otherwise

seems to be arrested. A lesion is considered mechanically

unstable if in spite of the arrest of the vertebral disease

the patient gets discomfort in the back on doing normal

work. Radiologically such lesions may show significant

destruction of more than two vertebrae and lack of

regeneration of vertebral bodies during the process of

healing. The main indications for surgical intervention

on vertebral lesions are summarised in Table I.

Post-operative management-After decompression or

d#{233}bridement or arthrodesis the patients are nursed on a

hard bed ; when necessary a plaster-of-Paris bed is used

for the first two to three weeks. In cases with neural

complications the patient is gradually mobilised out of

the bed with the help of spinal braces six to nine months

after the operation. In the absence of paraplegia, mobili-

sation with spinal braces is started at three to six months.

The spinal brace is gradually discarded about twelve to

eighteen months after the operation.

OPERATIVE PROCEDURES

For decompression and d#{233}bridement, with or without

bone grafting, the cervical spine and cervico-thoracic

junction have been exposedthrough an anterior approach;

the thoracic spine and thoraco-lumbar junction through

an antero-lateral approach or rarely through the trans-

pleural approach ; and the lumbar spine and lumbo-sacral

junction through an extraperitoneal approach or rarely

through a transperitoneal approach. Laminectomy has

been used for excision of the diseased bone in posterior

spinal disease and in cases of paraplegia caused by extra-

dural granuloma or tuberculoma. Anterior transposition

of the cord through the antero-lateral route was performed

in two cases with an extreme degree of kyphotic deformity

and paraplegia. More recently we have been trying to

correct severe kyphotic deformities by halo-pelvic traction.

RECRUDESCENCE OF DISEASE

Recurrence or relapse of a tuberculous lesion in the spine

poses a special problem. Sometimes there may be a

reactivation complicated by neurological involvement.

Perhaps the commonest cause is a grumbling activity of

infection caused by a resistant strain of acid fast bacilli

in a patient with relatively poor general resistance. In

such a situation a thorough clinical and radiological

examination may be helpful in localising the areas of

activation. Special investigations such as tomo;:aphy and

myelography in cases of neural involvement may be of

help in localising the disease.

The diseased area is explored and thorough clearance

is performed. The patient is treated by appropriate

supportive therapy, second line antitubercular drugs in

conjunction with isoniazid and a three weeks’ course

of streptomycin after operation. At the time of d#{233}bride-

ment bone grafting may be performed if there is any

evidence of instability; decompression of the cord is

performed when there is neural involvement.

FIG. I FIG. 2

Radiographs of a case of tuberculosis of the thoracic spine at thetime of presentation (October 1968). The antero-posterior viewshows a paravertebral abscess shadow and the lateral view shows adestructive lesion with marked diminution of the intervertebral

space.

FIG. 3 FIG. 4

Radiographs of the same case fifteen months after treatment as anout-patient by triple drug therapy and appropriate rest. Notespontaneous absorption of the paravertebral abscess, osseousreplacement of the intervertebral space, healing by bone block

formation and no appreciable increase in kyphosis.

RESULTS OF TREATMENT OF SPINAL TUBERCULOSIS BY “MIDDLE-PATH” REGIME 15

VOL. 57-B, No. I, FEBRUARY 1975

RESULTS

The results presented here are based upon personal

observations during the treatment of patients suffering

from tuberculosis of the spine during the last ten years.

The observations are based upon 900 cases, including

200 cases oftuberculous paraplegia. The number of cases

which were available for various follow-up studies are

mentioned in the appropriate sections.

Pain-Back pain and tenderness were relieved in 96 percent

of cases at the end of twelve months’ treatment.

Sinuses-All the sinuses healed within one to seven

months with treatment by antitubercular drugs (average

3.4 months). Multiple sinuses healed almost simultan-

eously. There was no problem of persistent sinus forma-

tion even after extensive operation. A small number of

sinuses which failed to respond to drugs within three to

four months healed after excision of the sinus tracks.

between six and twelve months. Second line antituber-

cular drugs were used in conjunction with operation for

these recurring cases.

Deep-seated radiological paravertebral abscesses-Obser-

vations regarding response to non-operative treatment

are based upon seventy-two patients who had deep-seated

radiological abscess and in whom operation was not done

as the first procedure. Sixty-eight per cent of abscess

shadows disappeared spontaneously within six to twelve

months (Figs. 1 to 4), in 16 per cent the shadow regressed

to constant size and in 14 per cent it appeared calcified.

In 2 per cent of cases the deep seated paravertebral

abscess required drainage because the size of the abscess

increased in successive radiographs in spite of treatment

or because an abscess in the neck caused difficulty in

breathing and swallowing. Our observations compare

favourably with those of Konstam and Konstam (1958);

Kaplan (1959) ; Konstam and Blesovsky (1962); Stevenson

Sinus ramification is always greater than can be

appreciated from the appearance of the openings or the

quantity ofthe discharge. The sinus tracks lead in various

directions and for great distances, so that complete opera-

tive excision is difficult and indeed impracticable. With

triple drug therapy operation is rarely necessary. Similar

observations are reported by Bosworth and Wright (1952);

Hald (1 955) ; Kaplan (1 959); Konstam and Blesovsky

(1962); Bosworth (1963) and Paus (1964).

Palpable (peripheral) cold abscesses-Repeated aspiration

and instillation of streptomycin was sufficient to heal

85 per cent ofabscesses; 10 per cent healed after operative

evacuation. Most of the abscesses were healed within

six months. Nearly 5 per cent of abscesses were not fully

controlled in spite of operative drainage and continuous

treatment. These abscesses were probably caused by

resistant strains of mycobacterium. Some of them pre-

sented with recurrence after a quiescent period varying

and Manning(l962); Konstam (1963); American Thoracic

Society (1963) and Friedman (1966). The presence of an

abscess does not seem to inhibit the process of healing.

On the basis of the results of the present and of other

studies, it is suggested that a less aggressive attitude

should be adopted towards radiologically demonstrable

paravertebral abscesses. Drainage may be considered in

cases with neurological complications, in those having

difficulty in swallowing and breathing, or in those with

abscesses getting bigger in spite of adequate antituber-

cular therapy.

Neurological complications-All the patients were given

the treatment outlined. The overall results in 200 patients

are summarised in Table 11. Thirty-eight per cent re-

covered on conservative therapy alone and six patients

died three to four weeks after admission and the beginning

of treatment. The cause of death in these patients was

poor general condition with visceral tuberculous foci,

16 S. M. TULI

THE JOURNAL OF BONE AND JOINT SURGERY

tuberculous meningitis, or both. In nine cases drainage

of prevertebral abscesses was performed in cervical or

cervico-thoracic lesions. In the remaining 1 18 patients

who failed to respond to closed treatment or whose

disease was too far advanced to permit observation for

a long time, the cord was decompressed by operation.

Of these, eighty-one (69 per cent) recovered fully, thirteen

( 1 1 per cent) had recovery sufficient to enable them to

walk with a moderate degree of support, ten (8 per cent)

failed to show appreciable motor recovery though they

had improvement in sensation and in sphincter function,

and fourteen (12 per cent) died. One death occurred

forty hours after operation from hypostatic pneumonia;

the other patients died between four and twelve weeks

after decompression, the causes of death being tuber-

culous meningitis, uraemia, ascending urinary tract infec-

tion, renal failure and toxaemia associated with bedsores.

The results of decompression in our series viewed

separately from results in patients who responded to the

conservative regime may appear to be poorer than those

in many other series in which surgical decompression was

performed in all the patients. However, in the present

series decompression was performed principally when the

neurological signs failed to respond to conservative anti-

tuberculous treatment while in the series in which decom-

pression was performed in all patients, operation may

have received credit for recoveries which would have

occurred anyway on conservative therapy alone. The

overall response in our series shows a success rate of

78�5 per cent, which compares favourably with the results

of any other series. In Konstam and Blesovsky’s (1962)

series twenty-eight of fifty-six patients with paraplegia

(50 per cent) got well with antitubercular drugs alone

and did not need operation. The other twenty-eight

(50 per cent) underwent operation. in twenty-six of these

simple operations like drainage of abscesses were done

and antero-lateral decompression was done in only two.

Twenty-five of these recovered. In Friedman’s (1966)

series ten (43#{149}4per cent) of twenty-three paraplegics

recovered with closed methods of treatment and the

remaining thirteen (566 per cent) needed operations.

Three ( 1 32 per cent) underwent costotransversectomy

and ten (43#{149}3per cent) antero-lateral decompression. in

Roaf, Kirkaldy-Willis and Cathro’s (1958) series, too,

recovery from paraplegia was seen with conservative

treatment. Evidently many patients with Pott’s paraplegia

recover simply with adequate and prolonged treatment

by antitubercular drugs. Operative decompression is

indicated in patients who fail to respond to drug therapy

(Tuli 1969) or in cases of recurrence.

TABLE II

OVERALL RESULTS IN 200 CASES OF NEURAL INVOLVEMENT COMPLICATING CARIES OF THE SPINE.

Minimum duration of follow-up of six months in those surviving

Severity ofVertebral Number of neural Number oflevel patients involvement patients

Number ofMode of treatment patients

Results

Number ofResult patients

Cervical I 3 Tetraparesis 10Tetraplegia 3

Conservative 2Conservative+traction+? drainage 9Anterior decompression 2

Success 10Partial success 2Failure 0Death 1

Cervico-thoracic I 3 Tetraparesis 3Tetraplegia 10

Conservative 2Conservative + traction +? drainage 7Anterior decompression 4

Success I 2Partial success 1Failure 0Death 0

Thoracic 1 39 Paraparesis 29Paraplegia 1 10

Conservative 46Decompression 93

Success I 11Partial success 5Failure 7Death 16

Thoraco-lumbar 21 Paraparesis I 1Paraplegia 10

Conservative 8Decompression 13

Success 18Partial success 0Failure 2Death 1

*Lumbar 10 Paraparesis 7

Paraplegia 3Conservative 8Decompression 2

Success 6Partial success 2Failure 0Death 2

*Lumbo�cral 4 Paraparesis 2

Paraplegia 2Conservative -

Decompression 4Success 0Partial success 3Failure IDeath 0

* Cauda equina lesion.

Patients who had motor weakness but were able to walk without support were classified as having tetraparesis or paraparesis whereasthose unable to walk because of paralysis were included under the heading of tetraplegia or paraplegia. Advanced paralysis was oftenassociated with other complications such as para-anaesthesia, sphincter involvement, or both.

FIG. 8 FIG. 9

Lateral radiographs of a case of tuberculosis of lumbar spine.Figure 8-At the time of presentation. Figure 9-After one yearoftreatment, as an out-patient, by antitubercular drugs and approp-nate rest. Restoration of the bony texture and osseous replacement

of the anterior part of the intervertebral space is obvious.

RESULTS OF TREATMENT OF SPINAL TUBERCULOSIS BY “MIDDLE-PATH” REGIME 17

4

Onset and speed of neural recovery after operation-The

first objective evidence of neural recovery was observed

twenty-four hours to twelve weeks after decompression.

No significant correlation was found between the pattern

of motor recovery (for instance, starting distally or

proximally), the onset and speed of recovery after decom-

pression, and other clinical factors such as degree and

duration of neural involvement. Most of the patients

showed the first evidence of objective recovery within

three weeks of decompression ; others, however, took

longer to recover. Four patients in the present series

started showing recovery ten and twelve weeks after decom-

pression, two recovered completely and two had partial

recovery. The time taken for nearly complete recovery

varied between three and six months. Clinical features

which influence the prognosis of neurological recovery

are shown in Table 111.

TABLE III

CLINICAL FACTORS INFLUENCING PROGNOSIS IN CORD INVOLVEMENT

Betterprognosis

Relatively poorprognosis

Cord involvement

Degree . . . . Partial Complete

Duration . . . Shorter Longer

Type . . . . “Early onset” “Late onset”

Rate of involvement . Slow Rapid

Age . . . . . Younger Older

General condition . . Good Poor

Plantar response-An extensor plantar response, a sign of

pyramidal tract involvement, lasted for a very long time.

We had an opportunity to study this response eighteen

months after the start of treatment in sixty-five patients

who had achieved “complete” neurological recovery. In

thirty-six cases (554 per cent) the response was extensor

on one or both sides and in twenty-nine cases (446 per

cent) it was flexor or equivocal. Early return of the flexor

response was seen in cases of milder neurological

involvement.

Recurrence or relapse of neurological complications-One

hundred patients with neurological involvement who had

completely recovered were followed up for periods varying

from three to ten years. Two reported with recurrence

of paraplegia after three years of complete recovery, one

due to an extradural granuloma and one apparently due

to severe kyphosis.

Of 144 patients without neural complication who

had complete healing, twenty-four patients were followed

for two years, thirty-nine between two and three years,

forty-seven between three and four years and thirty-four

for more than four years. One hundred and forty-one of

these developed neither neurological complications nor

VOL. 57-B, No. 1, FEBRUARY 1975

relapse of the disease. One child who had a very severe

kyphotic deformity reported back with neurological corn-

plications apparently due to the deformity five years after

the first presentation. Two patients reported with recrud-

escence of the disease between three and five years.

FIG. 5 FIG. 6 FIG. 7

Lateral radiographs of a case of tuberculosis of cervical spine (fifthto seventh vertebrae) treated by drugs and appropriate rest. Figure5-(March 1972) at the time ofpresentation. Figure 6-(September1972). Figure 7-(September 1973) during follow-up. Notereconstruction of the destroyed vertebral bodies, fibrous healingbetween the sixth and seventh vertebrae and anterior bone bridge

formation between fifth and sixth vertebrae.

Fate of the intervertebral spaces without operation-Of

the 200 patients who could be followed up for at least

one year twelve at the time of presentation showed intact

intervertebral spaces. These had central, anterior or

appendiceal type of tubercular lesions. The radiological

appearance of the intervertebral space in these cases

remained unchanged and intact at the last follow-up.

The rest ofthe patients had varying degrees of diminution

and destruction of intervertebral spaces. Fifteen per cent

had fibrous (Figs. 5 to 7), 52 per cent had mixed (partly

fibrous and partly osseous) and 3 1 per cent had osseous

(Figs. 8 and 9) replacement of the intervertebral spaces.

it was observed that in cases in which the disc was

completely destroyed and there was obliteration of the

intervertebral spaces there were more chances for the

FIG. 10 FIG. 11 FIG. 12 FIG. 13

Lateral radiographs ofa case oftuberculosis of the dorso-lumbar region showing a destructive lesion and diminution of the inter-vertebralspace at the time of presentation. Figure I0-(March 1966). Figure 1 I-Note spontaneous healing by antitubercular chemotherapy attIe end of twenty-one months (December 1967). Figure 12-At twenty-nine months. Figure 13-At fifty-eight months. A shift from

fibrous replacement of the intervertebral space to fibro-osseous and osseous replacement is obvious with longer follow-up.

FIG. 14 FIG. 15 FIG. 16

Lateral radiographs of a child with tuberculosis of the mid-thoracic spine treated by triple drug therapy, appropriate rest and bracing.Figure 14-(1967) at the age of 2 years. Figure 16-( 1971 ) at the age of 6 years. Note gradual reconstruction of the destroyed vertebrae,

gradual change to osseous replacement of the disc space with negligible increase in the angle of kyphosis.

18 S. M. TULI

THE JOURNAL OF BONE AND JOINT SURGERY

lesion to heal by bony replacement of this space (Figs.

2, 4 and 10 to 13). It was noted that with longer follow-up

there was shift from fibrous replacement towards osseous

replacement of the intervertebral space (Figs. 10 to 13

and 14 to 16).

Fate of the intervertebral space with operation-Eleven

per cent of cases had mixed fusion and 89 per cent had

bony healing of the vertebral lesion when assessed

eighteen months after operation.

Radiological healing of vertebral lesion-After control

of the infection, the spine in most of the patients in the

present series achieved stability without severe deformity.

In a large proportion of lesions in which tubercular

spondylitis was of the paradiscal or metaphysial variety,

a spontaneous interbody bony or mixed fusion with

clinical healing took place (Table IV). In a much smaller

group clinical healing took place, with fibrous replace-

ment of the space between the involved vertebrae. Re-

generation of involved vertebral bodies was observed in

many cases under the influence of antitubercular drugs

(Figs. 5 to 7).

Before the use of chemotherapy, when non-osseous

tissue persisted between partially destroyed vertebral

bodies, the arrest of the disease proved to be temporary

in a large number of patients. The disease often became

reactivated to break down what had appeared to be a

fibrous ankylosis. Long-term prediction regarding recrud-

escence of the spinal disease in patients with intact

intervertebral space or its fibrous replacement cannot be

made from the present study. Further work on this aspect

is in progress in our institution. However, in the present

study we had an opportunity to observe seventeen lesions

RADIOLOGICAL HEALING IN VARIOUS SERIES

Osseous Fibrous Intact disc Total

. 155 9

. 76

. 38 14

. 41

. 31 (298 per cenO 52 (50 per cent)

Strict comparison is difficult because of varying criteria used by different workers to categorise the patients, and varying duration offollow-up. Many workers have used only the term successful “fusion”, which has been put under osseous healing in this table. Thedifference between the total number of patients/lesions and the sum of the corresponding figures under various headings in a particularseries is due to the fact that some workers have excluded deaths and “failures” from their figures (adapted from Tuli and Kumar 1971).

RESULTS OF TREATMENT OF SPINAL TUBERCULOSIS BY “MIDDLE-PATH” REGIME 19

VOL. 57-B, No. I, FEBRUARY 1975

in which the intervertebral space was intact or replaced

by fibrous tissue. These were followed for periods varying

from fifteen to seventy-two months. All these lesions

remained inactive during this period of follow-up.

Bony and mixed replacement of the intervertebral

space were not synonymous with clinical healing. In

two patients who had complete bony fusion the disease

was still clinically active; another two had mixed fusion

and active disease.

Observations regarding radiological healing in our

and in other series are shown in Table IV. Konstam and

Blesovsky’s (1962) series and ours have many features in

common and can reasonably be compared. It seems

probable that if an intervertebral space is intact at the

time of first examination-as happens commonly in the

central and anterior types of lesions of the body-the

space may remain so throughout the course of treatment

and follow-up. On the other hand, in the common

paradiscal type of disease 847 per cent of lesions achieve

fibro-osseous or osseous replacement of the involved

discs after twelve months of triple drug therapy.

Course of kyphosis in patients not operated upon-Obser-

vations were based upon 104 lesions followed up for at

least one year. In thirty-two cases the kyphosis increased

by more than 5 degrees ; the disease in three of these

patients was active at the end of twelve months or more

of follow-up. In seventy-two cases the kyphosis increased

by 5 degrees or less; the lesion in one of these was active

after more than twelve months. Increase of kyphosis by

more than 30 degrees was seen in only six patients : four

of these were children, and all of them had involvement

of more than three vertebral bodies. It seemed that

multiple vertebral involvement, active growth and situa-

tion of the lesion in the thoracic spine were responsible

for excessive increase in kyphosis. Increase of kyphosis

was observed in 667 per cent of thoraco-lumbar lesions,

55 per cent of thoracic lesions and 33�3 per cent of lumbar

lesions. One of the patients with severe kyphosis who

had a clinically and radiologically healed lesion at the end

of the treatment started showing neurological complica-

tions after five years of follow-up, apparently because of

the severe deformity. Conservative treatment in con-

junction with triple drug therapy does not prevent the

progress ofkyphosis (Konstam and Blesovsky 1962, Paus

1964, Friedman 1966, Dickson 1967). However, even

spines with solid posterior fusion have shown progress

in kyphosis during follow-up (Bakalim 1960). Similar

observations regarding increase in kyphosis have been

reported by other workers in patients treated by direct

surgical extirpation of the vertebral lesion. In our study

an increase of 10 degrees or more of kyphosis was seen

in only 20 per cent of lesions during the period of follow-

up. In the rest of the lesions (80 per cent) the curvature

of the spine either remained static or kyphosis increased

by less than 10 degrees or decreased.

Six lesions in the present series had an increase in

kyphosis of more than 30 degrees. In all these the lesion

was in the thoracic spine. This is in agreement with Puig

Gun’s (1947) and Friedman’s (1966) observations. Puig

Gun (1947) stated that the destruction of a thoracic

vertebral body resulted in a posterior displacement of the

centre ofmotion, a subluxation at the level ofthe articular

facets and increase in weight borne by the anterior part

of the body. In the lumbar spine, the large bodies and

vertical articular facets are more apt to telescope than

to angulate. The cervical spine is prevented from tele-

scoping by the interposition of the transverse processes,

and in this part of the spine there was the least deformity.

Kyphosis is more common in the thoracic spine and this

region is subjected to the greatest degree of angulation.

Almost the whole of the deformity takes place during the

active phase of spinal disease. Development of kyphotic

TABLE IV

Healing

Radical operation

Fibro-osseous(mixed)

Number of cases

Roafet al. (1959) .

Hodgson and Stock (1960)Paus (1964) . .

Wilkinson (1969) .

Primarily drug therapy

Konstam and Blesovsky (1962)Kaplan (1959) . .

Friedman (1966) . .

Stevenson and Manning (1962)Tuli and Kumar (1971) .

57945989 (62�2 per cent) 24 (168 per cent) 22 (154 per cent) 8 (56 per cent)

1449

52715 (144 per cent) 6 (58 per cent)

76100103143

207I39

5773

104

20 S. M. TULI

THE JOURNAL OF BONE AND JOINT SURGERY

deformity after the clinical healing of the disease seems

to be uncertain. The only way to minimise the increase

in kyphosis seems to be recumbency in the early active

stage and prolonged protection with suitable braces in

the later stages.

Radiological kyphosis in patients operated upon-Adequate

assessment of the progress of kyphotic deformity was

possible in fifty-two patients who were followed for

periods of from two to six years. Increase in kyphotic

deformity by 10 degrees or more was observed in 19 per

cent ofcases. In the remaining 81 per cent the deformity

either remained static or the increase in angulation was

less than 10 degrees. The deformity in the operated cases

became stable by about eighteen months in most cases.

In one case (a child aged four with a lower thoracic

lesion) the kyphosis increased by 25 degrees two years

after operation, possibly because the disease remained

active. There does not seem to be much difference in the

behaviour of kyphosis between patients treated by radical

operation (Paus 1964), those treated by conservative

methods (Konstam and Blesovsky 1962), and those

treated by the “middle-path” method (Tuli and Kumar

1971).

Clinicalhealingincaseswithoutneurologicalcomplications-

Ninety-six per cent of such lesions were inactive clinically

and radiologically after twelve months of drug therapy.

All these patients were able to return to their work. Four

per cent of lesions did not show a favourable response to

conservative treatment : these were subjected to d#{233}bride-

ment; all ofthem were controlled by this method. Clinical

healing of the lesions was judged by local and general

signs and symptoms and radiological observations. After

clinical healing patients engaged themselves in “normal

activity” according to the criteria of Stevenson and

Manning (1962) and had “complete working capacity”

as described by Paus (1964). Women were leading their

normal family life and many were able to bear children

(Wilkinson 1955; Hodgson and Stock 1960; Yeager 1963;

Paus 1964). The results of orthodox treatment obviously

were poor in the days when antitubercular drugs were

not available. Treatment by antitubercular drugs, either

conservatively or in conjunction with radical surgical

extirpation, on the whole gives good results (Table VI).

We feel that the operation should be reserved for compli-

cations of spinal tuberculosis such as failure to respond

to conservative treatment within three to six months,

paraplegia not controlled by chemotherapy, abscess

not resolving after repeated aspirations, and pain and

instability. Many other workers have similar feelings

(Kaplan 1959; Chofnas, Surrett and Severn 1964).

Relapse or recurrence of complication-Exact assessment

of the incidence of relapse or recurrence of complication

is not possible because these problems may occur at any

period during the lifetime of a patient. Reactivation or

development of complications has been observed even

during the era of antitubercular drugs as late as twenty

years or more after apparent healing (Martin 1970).

One hundred and eighty-one cases of tuberculosis of

the spine who had achieved clinical healing by following

the “middle-path” regime were followed up by us for

periods varying from three to ten years. Two patients

(treated earlier by operation) came with recurrence of

paraplegia (one due to extradural granuloma and one due

to severe kyphotic deformity) ; one child developed com-

plications apparently from severe kyphotic deformity;

two patients developed reactivation of the spinal lesion

(one had been treated earlier by operation and one had

healed with conservative treatment only) ; one patient

treated earlier by surgical d#{233}bridement and bone grafting

developed recrudescence of the vertebral lesion and died

of generalised miliary tuberculosis probably because of

resistant organisms. A high incidence of relapse rate or

development of neural or other complications cannot be

ruled out as some of such patients might not have

TABLE V

OVERALL RESULTS OF VAtuous REGIMES IN SPINAL CARIES

NeuralMortality Healing recovery Relapse(percentage) (percentage) (percentage) (percentage)

Orthodox (pre-antibiotic) . 30-50 33-44 40-60 ?

Conservativewithchemotherapy 0-10 80-90 60-80 2-5

Radical operation . . . 0-10 80-95 75-80 0-5

“Middle-path” . . . 0-10 80-95 75-80 2-5

without any signs of reactivation. Most of the adult

patients were either farmers or daily wage earners and

they were doing their work well.

The overall incidence of healing (Tables V and VI)

with conservative treatment varies in different series from

83 to 968 per cent. The incidence of healing after

operation is reported as between 80 and 96�8 per cent

reported to our institution for consultation and treatment.

The cause of reactivation of the disease in spite of

apparently adequate treatment at the time of initial ther-

apy, appears to be lowered nutritional status ofthe patient

or acquisition by the organisms of resistance to drugs.

The relapse rates reported by Paus (1964) and Girdle-

stone (1965) were 1 1 and 12 per cent respectively. Kaplan

RESULTS OF TREATMENT OF SPINAL TUBERCULOSIS BY “MIDDLE-PATH” REGIME 21

VOL. 57-B, No. I, FEBRUARY 1975

TABLE VI

COMPARISON OF RESULTS IN DIFFERENT SERIES OF PATIENTS TREATED BY VARIOUS WORKERS BY VARIOUS REGIMES,

AFTER INTRODUCTION OF EFFECTIVE CHEMOTHERAPY

Authors Mode of treatment

Clinicalhealing(percentage)

Neuralrecovery(percentage)

Death(percentage)

Relapse(percentage)

Kondo and Yamada (1957) . . Streptomycin alone (non-operative) 209 ? 9.3 302

Streptomycin with Albee’s operation 355 ? 0 355

Streptomycin with focal d#{233}bridement 52 ? 21 21

Falk (1958). . . . . Cases treated in 1946-48 withstreptomycin alone and spinal

arthrodesis in 69 per cent

66 ? 13 11

Hodgson and Stock (l960fl� .

Stock (1962) J_ .

Surgical treatment by anteriorapproach 93 74 4.4 ?

Konstam and Blesovsky (1962) . Antituberculous drugs. Operationonlyforfailureforparaplegia 96 89 15 2

Konstam 1963 . . . . Antituberculous drugs primarily 86 99 ? ?

Masalawala (1963) . . . Focal d#{233}bridement with bone grafting 91 742 62 3

Riskd and Novoszel (1963) . . Costovertebrotomy-spondylodesis(resection of one rib with posteriorarthrodesis) 82 95 1 7

Kirkaldy-Willis and Thomas (1965) Surgical treatment by direct approach 86 79 3.4 ?

Friedman (1966) . . . . Antituberculous drugs primarily 97 ? 41 188

Kohli (1967) . . . . Radical operation with

antituberculous drugs 81 844 3�5 ?

Arct (1968) . . . . .

(patients more than 60 years)Antituberculous drugs alone

Antero-lateral decompression withbonegrafting

26

847

0

60

18

10

31

0

Wilkinson (1969) . . . . Operative d#{233}bridement (1940-53) 80 ? 2 20

Operative d#{233}bridementwithchemotherapy (1954-62) 95 - 2 5

Tuli (1969), Tuli and Kumar (1971) Antituberculous drugs; operation forfailure only 95 80 8 ?

The results are not strictly comparable because there are variations regarding clinical material, criteria for clinical healing and durationof follow-up, during which death, “recurrence” or relapse are calculated. Only those series are tabulated where comparison was reasonablypossible.

?�=Difficult to calculate or not given clearly.

(1959) reported a rate of recurrence of 2 per cent in 130

patients. In Konstam and Blesovsky’s (1962) series only

one of 207 patients had recurrence. The low rate of relapse

(Table VI) is probably due to the effectiveness of anti-

tubercular drugs currently available. Yeager (1963)

observed that prolonged use of “combined antimicrobial

therapy has lowered the relapse rate to its lowest point

in our history”.

DISCUSSION

Radical operation for tuberculous disease of the spine

has been recommended by many workers on the supposi-

tion that drugs are unable to gain access to skeletal

tuberculous abscesses and necrotic bone (Wilkinson 1950,

1955, 1969; Orell 1951; Kondo and Yamada 1957;

Hodgson et al. 1960). Fell#{228}nder, Hiertonn and Wallmark

(1952); Katayama, Itami, Oya, Tanaka and Maruno

(1954) and Hev#{233}rand Risk#{243}(1960) observed various

concentrations of streptomycin in the diseased material

from human tuberculous lesions, but the results varied

widely because of the many uncontrolled parameters in

the human clinical material. It has more recently been

shown that radioactive dihydrostreptomycin (Andr#{233}1956;

Hanngren and Andr#{233}1964; Lindberg 1967) and radio-

active para-aminosalicylic acid (Hanngren 1959) reach

skeletal tubercular foci. Barclay, Ebert, LeRoy, Manthei

and Roth (1953) and Canetti (1955) reported that radio-

active isoniazid diffused freely into all tissues including

bone, as well as into abscess cavities and even dried

caseous material in sufficient concentration to destroy the

bacteria. Further work involving the use of bioassay

techniques has shown that the concentration of strepto-

mycin in the experimental tuberculous lesion after a single

22 S. M. TULI

THE JOURNAL OF BONE AND JOINT SURGERY

intramuscular injection (equivalent to therapeutic doses)

is much higher than that considered sufficient to have an

inhibitory effect on human type of mycobacterium tuber-

culosis (Tuli, Brighton, Morton and Clark 1974). Finally,

the clinical response of the spinal disease under chemo-

therapeutic treatment, with the quality of healing that is

more rapid and more consistent than seen before the use

of the antitubercular drugs, led many workers (Konstam

and Konstam 1958, Konstam and Blesovsky 1962, Kon-

stam 1963, Friedman 1966, Dickson 1967, Tuli et a!. 1967,

Tuli 1969, Tuli and Kumar 1971) to infer that the drugs

were indeed reaching the site of infection. These drugs

are so effective that they have made sanatorium treatment

unimportant (Fox 1962, 1964) and have obviated the need

for routine operation.

Few of the comparisons between the results of opera-

tive treatment and those of non-operative treatment are

valid, because usually the evidence regarding the results

of conservative treatment was obtained before modern

antitubercular drugs became available (Bailey et a!. 1972).

More objective comparison (Tuli 1973) of recent series

treated by antitubercular drugs alone or in conjunction

with radical operation on the whole offer evidence of the

effectiveness of the drugs.

Certainly, if the organism is sensitive to the anti-

tubercular drugs and the drug is administered for suffi-

cient length of time, the infection may well be controlled

and most of the lesions will heal. If a lesion does not

come under control the cause is not failure of the drugs

to reach the lesion in sufficient concentration. The cause

lies in other factors such as the nature of the mycobac-

terium (atypical being generally resistant), the resistance

ofthe infecting organism to the drugs and the mechanical

nature of the pathological lesion-for instance, the pres-

ence of large sequestra. The effects of antituberculous

drugs on skeletal tuberculosis were aptly summed up in

Girdlestone (1965): “In every skeletal lesion, there are

areas of bone which are infiltrated with tuberculous

disease but which are not necrosed. These will recover

under drug treatment. There are also areas of ischaemic

and infarcted bone and these will also recover without

operation because as the disease subsides, the circulation

in the lesion improves. Finally, there are areas of necrosis

which are past recovery and which harbour tubercular

bacilli. For these operative treatment in addition to drugs

is essential. Operation should be limited to such foci . .

CONCLUSIONS AND SUMMARY

By following the “middle-path” regime absolute indica-

tions for surgical intervention on the vertebral lesion are

reduced to 6 per cent of cases without neural complica-

tions and to 60 per cent of cases with neural deficit.

Ninety-four per cent of cases of tuberculosis of the

spine without neurological complications can achieve

clinical healing with an adequate course of chemotherapy

without surgical intervention on the vertebral lesion. The

overall results compare favourably with the published

results of radical operation. Of the 181 patients treated

by the “middle-path” regime who could be followed up for

three to ten years, three had recurrence and three returned

with complication of paraplegia.

Of the cases with neurological involvement, 38 per

cent recovered completely with drug therapy alone ; opera-

tion was performed for the remaining failures. Of the

patients who underwent decompression and d#{233}bridement

for neural complications, 69 per cent recovered completely.

The overall success rate in neural complications treated

by the “middle-path” regime was 785 per cent. Ofall the

recovered cases, 2 per cent reported again with recurrence

of complications.

In the patients treated by drug therapy alone, 19 per

cent revealed increase of kyphosis by more than 10

degrees. The diseased area went on to osseous replace-

ment in 296 per cent, fibro-osseous in 50 per cent and

fibrous in 202 per cent of cases. Of all the cases in which

the vertebral lesion was operated upon, 19 per cent

revealed increase in kyphosis by 10 degrees or more. The

diseased area radiologically revealed osseous replacement

in 89 per cent and fibro-osseous in 1 1 per cent of cases.

Because the results obtained by the “middle-path”

regime compare favourably with those of radical opera-

tion, it is suggested that triple drug therapy should be

used in the first instance. Operative treatment is suggested

for failure, recrudescence or complication.

My thanks are due to Mr D. K. Mathur and Mr S. P. Singh for illustrations and to Mr P. K. Mukherji and Mrs Swam for secretarial help.

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