International Orthopaedics (SICOT) (1994) 18:90-95 International Orthopaedics

© Springer-Verlag 1994

Modular endoprosthetic replacement after total resection of the femur for malignant tumour

H. G. Morris, R. Capanna, D. Campanacci, M. Del Ben, and A. Gasbarrini

Rizzoli Orthopaedic Institute, University of Bologna, Bologna, Italy

Accepted: 28 October 1993

Summary. Seven patients underwent total resec- tion of the femur with replacement by the Kotz modular femur and tibia reconstruction system (KMFTR); three of these operations were for pri- mary malignant tumours and four were salvage procedures after failed limb-sparing surgery. Clinical and radiological results were excellent or good at final follow up at an average of 23 months. A new method of radiological assessment has been used for the acetabular component of bipolar hip endoprosthesis. The polyethylene bush of the hin- ged knee component may wear. Reattachment of the abductors to the endoprostheses often fails and we now suture the abductors to the fascia lata. The rectus femoris muscle should be saved, if possible, after resection. When total excision of the quad- riceps is indicated, the knee should be arthrodesed. The KMFTR is easy to use and has provided good medium to long term results in our cases.

R6sum6. Sept rdsections totales du fdmur ont dtd traitdes par reconstruction b l'aide du systkme K.M.F.T.R (Kotz Modular Femur and Tibia Reconstruction). Dans trois cas il s'agissait de tu- meurs malignes primitives et dans quatre cas d'interventions de sauvetage pour dchec de chi- rurgie conservatrice. Le recul moyen est de vingt- trois mois (et dans trois cas supdrieur b 30 mois). A la fin de la pdriode de surveillance les rdsultats cliniques dtaient excellents ou bons et aucun pa- tient n'a eu besoin d'un appareillage ddfinitif

Reprint requests to: R. Capanna, First Orthopaedic Clinic, University of Bologna, Istituto Ortopedico Rizzoli, Via Pupilli 1, 1-40136 Bologna, Italy

Radiologiquement les rdsultats dtaient excellents ou bons dans tous les cas. Un nouveau systkme simple d'apprdciation radiologique de la pikce cotyloidienne de la prothkse bipolaire de hanche a dtd utilisd. Les complications traduisent la com- plexitd de ce type de chirurgie, mdme si Ies rdsultats obtenus sont comparables b ceux des autres au- teurs. Le frottement du polydthylkne dans le mdcanisme du pivot peut Otre cause d'dchec par usure prdcoce. La rdinsertion des abducteurs sur la prothkse est souvent en ddfaut et, pour cette raison, nous fixons maintenant les abducteurs au fascia lata. Aprbs rdsection il faut que le droit antdrieur au moins puisse ~tre conservd, si une excision totale du quadriceps est ndcessaim on doit se rdsoudre b une arthrodbse du genou. Nous trouvons que le systkme K.M.ET.R pour remplacement total du fdmur est d'utilisation facile, que sa modularitd est addquate et que les rdsultats gt moyen et long terme sont cliniquement et radiologiquement bons.

Introduction

Limb salvage surgery has become an accepted method of treatment for selected bone sarcomas of the extremities. As survival rates have improved, the long term behaviour and the associated ratings of the various methods of reconstruction have be- come an important issue, particularly as many of the patients are young. Revisions for the compli- cations of these large implants are more common and amputation is often necessary. Total femoral replacement, although a massive undertaking, provides a means of limb salvage.

H. G. Morris et al.: Modular endoprostheses following femoral resection for malignancy 91

Table 1. Age, sex, indications, histological diagnosis and stage (according to Enneking), surgical margins, clinical and radiological results and follow up in 7 cases of total femoral replacement

Case

Age

Sex

Indication

Diagnosis

Stage

Margin

Results Function hip G Function knee G X-ray Meta R F X-ray Meta I E X-ray Meta A E X-ray hip G

Follow-up (month) 53

1 2 3 4 5 6 7

15 15 13 17 53 17 61

M F F M M F M

Salvage Salvage 1 ° 1 ° 1 ° Salvage Salvage

Infected Frac. fern. Osteosarc Osteosarc Angiosarc Frac. pro, Enders nails allograft above pro stem across FS

N/A N/A IIB IIB IIB N/A IIB

N/A N/A Wide Wide Wide N/A Wide

E G E E E N/A G G E E E N/A E E G E E N/A E E E E E N/A E E E E E N/A G G E E E N/A

46 30 18 9 6 Amp 15 days

Frac. = Fracture, fem. = femur, pro. = prosthesis, FS = Fibrosarcoma Amp = Amputation Functional evaluation according with Enneking grading sys- tem (5) E = Excellent, G = Good, F = Fair, P = Poor

M a t e r i a l a n d m e t h o d

Seven patients underwent total femoral replacement with the Kotz modular femur and tibia reconstruction system (KMFTR) from 1987 to 1992. One patient had a disarticulation at the hip 15 days after the operation because ischaemia of the leg had developed. The remaining six patients were followed up for between 6 and 53 months, three for longer than 30 months. Incisional biopsy was carried out and the histological diag- noses are given in Table 1. There were three cases of primary total femoral replacement. The other four were salvage pro- cedures after complications following previous limb-saving operations: after a fracture of the femoral neck above a distal femoral resection; following salvage of an infected allograft (Fig. 1 a, b); for fracture of a prosthetic diaphyseal stem in a high distal femoral resection; and where Enders nails had been inserted across a pathological fracture through a fibrosarcoma.

Patients with osteosarcoma were given adjuvant chemother- apy based on the regimens on trial at the Rizzoli Institute.

The KMFTR endoprosthesis was developed in 1982 [8] and has been used in our Institute since then. The hip articulation is bipolar and the outer head is sized according to the measure- ment of the femoral head which is made at operation; a polyethylene liner and a 32 mm prosthetic articulation (Bi- centric system) are used. The proximal femoral part has a porous coating on its shoulder for re-attachment of the abductor muscles with a polyethylene plate and two screws, if this is desired. The connecting pieces are totally modular, with segments from 6 cm to 14 cm in increments of 2 cm, and are joined to the main replacement by morse tapers. The bridging parts are joined during operation by two connecting pieces and held together with two screws. The tibial metaphy- seal section consists of a stem and two lateral flanges; the stem and base plate are fully madreporique. The joint is a flexion/ extension hinge with a polyethylene bush, the centre of rotation being offset posteriorly (Fig. 2).

X-ray Meta R = Metaphyseal Remodelling (ISOLS) X-ray Meta I = Metaphyseal Interface (ISOLS) X-ray Meta A = Metaphyseal Anchorage (ISOLS) X-ray Hip = Hip assessment (bipolar prostheses), see Table 4 N/A = Not Applicable

Surgical technique. The Watson-Jones approach to the hip is used, with a long incision on the lateral side of the thigh. The gluteus medius and minimus, together with the external rotator muscles, are detached depending on the surgical margin at this level. The gluteus maximus tendon is divided and the sciatic nerve exposed and protected. Part or all of the quadriceps is excised en bloc with the tumour according to standard onco- logical surgical principles; the rectus femoris is preserved if possible to enhance hip flexion, and more important, knee extension. If the whole of the quadriceps muscle has to be excised, we recommend arthrodesis of the knee [2]. The cap- sule is divided circumferentially near the acetabulum and the femoral head dislocated; the insertion of the psoas may now be divided. Distally, the patella is dislocated medially. The neu- rovascular bundle is exposed and separated from the tumour, with ligation of the vessels passing to the tumour and femur. Muscles attached to the linea aspera are divided together with the insertion of adductor magnus. The femur is then removed after division of the capsule at the knee. Great care must be taken with the neurovascular bundle since tension may damage either the vessel or nerve. The proximal tibia is osteotomised and reamed for the press-fit insertion of the tibial component. The parts are then assembled and a trial reduction carried out to test stability and tension. The glutei and remaining vasti were attached to the endoprosthesis in three early cases, but in later patients sutured to the ilio-tibial band. Meticulous hae- mostasis is essential and as much of the dead space as possible eliminated. The endoprosthesis is covered with the remaining muscles and the wound closed in layers over 4 large-bore suction drains.

The average operating time was 4.3 h and blood loss during operation was 1.2 1.

After operation, a hip spica cast was applied and the patient kept in bed, usually for 2 to 3 days, until drainage had stopped and the tubes removed. The cast was removed at 30 days, nonweightbearing walking allowed with passive movements

92 H.G. Morris et al.: Modular endoprostheses following femoral resection for malignancy

Fig. 1.a Radiograph of a boy, aged 15 years, who had a Ewing's sarcoma of the shaft of the femur. He was treated initially by diaphyseal resection and reconstruction with a bridging allograft and a long plate, b Radiograph showing evidence of infection at 2 months. This was treated by debridement and gentamicin beads. e Photograph at operation after 11 months when a total femoral substitution was carried out using a KMFTR endoprosthesis. d Radiograph at 53 months, e, f The clinical and functional result was good. The right leg was 5 cm shorter than the left

for 2 weeks, after which weightbearing was started. Rehabili- tation continued for several mouths. Radiographs were as- sessed by the ISOLS classification (Table 2), and a new grading system was used for analysis of the bipolar prostheses and acetabulum (Fig. 3).

The patients were all examined at the final follow up and graded according to the Enneking system for the functional evaluation of the surgical management of musculoskeletal tumours [5].

Results

The functional and radiological results are shown in Table 1 and all were excel lent or good at be- tween 6 and 53 months , with the except ion of the

radiological appearance in one case. There was no worsening with time, but this m a y be a reflection o f the small number of cases in the series.

Complications

Failure of the bush in the hinge mechan i sm oc- curred in one case at 46 months and was dealt with by rep lacement of the polye thylene bush. This type of failure is usual ly manifes t by varus/valgus in- stability, decrease in the range of mot ion or clunking, but rarely with pain. Revis ion is required to prevent meta l wear and eventual b reakage of the hinge ring, which might require revis ion of the whole segment which is much more difficult than

H. G. Morris et al.: Modular endoprostheses following femoral resection for malignancy 93

Fig. 2 a, b. Photographs of the KMFTR system, a The mod- ularity allows the prostheses and the substitute femur to be assembled to any length, b The tibial stem and the inter- trochanteric part of the endoprosthesis are madreporique to allow bony ingrowth from the tibia and at the attachment of the gluteal muscles

s i m p l y c h a n g i n g the bush. L o o s e n i n g of the screw in the c o n n e c t i n g p iece in one case was t rea ted by t i g h t e n i n g the screw. In ne i the r o f these pa t i en t s was there a decrease in f u n c t i o n a l or r ad io log ica l g rad ing . F rac tu re of the t ib ia b e n e a t h the en- dopros thes i s f o l l o w e d an i n ju ry in one case; this was t rea ted c o n s e r v a t i v e l y wi th a good result .

I b

f

Fig. 3. Bipolar hip prosthesis: radiographic assessment, a a, Distance from tear drop to prosthesis; b, distance from superolateral acetabular corner to medial prosthesis; c, superior joint space; d, distance from tear drop to superior prosthesis aN well-centered AP radiograph is required of the pelvis and both hips. Subsequent X-rays need to be of similar orientation and magnification if meaningful comparisons are to be made. The joint space is calculated (in mm) on successive X-rays. Medial migration is estimated by comparing the tear drop to prosthesis distance. Superior migration is estimated by com- paring the distance from the tear drop to superior prosthesis. Subluxation is estimated by comparing the distance from the superolateral acetabular corner to the medial prosthesis. Sclerosis is seen in the juxta-acetabular metaphyseal bone superiorly. Deformity is seen medially and usually manifests as a protusion. The grading scale is: E = excellent; G = good; F = f a i r ; P = poor E = No loss of joint space superiorly, no migration medially or superiorly, no subluxation, no pelvic reaction-deformity or sclerosis G = Loss of joint space but no migration, or subluxation < 1/4 diameter of prosthesis or slight sclerosis F = Complete loss of joint space plus migration < 1 cm, subluxation > 1/4 diameter but no dislocation, moderate pelvic reaction F = Complete loss of joint space plus migration > 1 cm dis- location, pelvic discontinuity or severe sclerosis

Table 2. ISOLS grading system for radiological assessment of endoprostheses

1. Bone remodelling 2. Interface 3. Anchorage

Excellent No change

Good a) hypertrophy+ b) sclerosis or c) osteopenia with no geometric change d) bone angulation <5 °

Fair a) osteolysis, hypotrophy of fixation area < 50% + > 1/3 length

b) bone angulation >5 °

Poor a) osteolysis or hypotrophy of fixation area > 50% thickness +1/3 length or

b) bone fracture

No radiolucent (RL) line

radiolucent line < 2 mm thickness < 1/3 length

a) RL line < 2 mm + > 1/3 length b) axial migration < 5 mm

a) RL line > 2 mm + > 1/3 length or b) > 5 mm axial migration or c) loosening

a) no change b) satisfactory cement technique

Inadequate cementation but no change or failure

a) stem deformation b) screw fracture, c) plate fracture a d) cement fracture a

a) stem fracture b) screw fracture b c) plate fracture b d) cement fracture b

a No loosening b Fracture with loosening

94 H.G. Morris et al.: Modular endoprostheses following femoral resection for malignancy

Table 3. Summary of previous reports of total femoral replacement

Author(s) Date Type No FU (mo) Observations

Ottolenghi 1957 Allograft 1 84 Buchanan 1965 Custom, M+H 1 6 Engelbrecht 1974 St Georg+PE 3 - Marcove 1977 Custom, M+H, C 19 3-29 Katznelson 1980 Custom, M+A 5 15-30 Steinbrink 1982 Various 28 - Capanna 1986 Custom, B+A 2 24-48 Nerubay 1988 Custom, M+A 18 12-96 Delepine 1990 Composite, S+H 8 - Lavoie 1991 Various 53 3 - 190

Fracture fem. neck, osteonec. Good result, no further comment Prosthetic breakage early Fair results, LT bracing Exc results for hip, stiffened knee Good hip, poor knee results Exc hip results, stiffened knee See Katznelson. High complications Short FU. Ex, good results Variable results, high complications

Custom = Custom prosthesis M+H = Moores type hip with hinge knee M+A = Moores type hip with arthrodesis of knee

B+A = S+H =

Bipolar type hip with arthrodesis of knee Standard THR with hinge knee

One patient, with preexisting peripheral vas- cular disease developed an ischaemic leg 13 days after operation; disarticulation at the hip was car- ried out 2 days later.

There were no infections or local recurrences. One death occurred from metastases from an an- giosarcoma 9 months after operation.

Discussion

Buchanan carried out the first total femoral re- placement in 1952, and reported a second case in 1965, using a custom-made vitallium endopros- thesis, with a good functional result at 6 months [1]. In 1957, Ottolenghi transplanted a whole fe- moral allogaft in a patient with hydatid disease. The result was reported as good after 7 years, in spite of a sound arthrodesis of the knee and non- union of a femoral neck fracture [12].

During the last twenty years, 8 reports have been published describing the technique, compli- cations and results of total replacement of the femur [2, 3, 4, 7, 9, 10, 11, 15, 16] and these are summarised in Table 3.

A high grade malignant sarcoma (stage IIB), with a proposed 30% incidence of skip lesions, has been the indication for this procedure [10], but since imaging by CT and MRI has made it possible to exclude skip metastases, we now believe that a wide margin of bone ( 2 - 3 cm) with a cuff of soft tissue is adequate in most cases of stage IIB sar- coma. Hence the indication for complete excision of the femur in the treatment of primary tumours is rare, but this radical procedure will usually be necessary when skip lesions are demonstrated or when there is a massive intramedullary extension of a diaphyseal sarcoma.

We have performed three total femoral re- placements for primary tumours in 4 years corn-

pared with about 230 limb salvage procedures for femoral turnouts in the same period. The other indication in our series was salvage after failure of previous attempts at limb-saving surgery. It is likely that breakage of prosthetic stems will be- come a major problem in years to come as this type of reconstruction begins to fail.

Occasionally, total femoral replacement will be required when the initial treatment is incorrect or in metabolic bone disease. Revision of failed ar- throplasties may, given time, also need this type of radical solution.

Although our series is small with a relatively short follow up, the functional results for the hip and knee are excellent or good. This may be ex- plained by our conservative postoperative re- habilitation programme, together with the tentative respect that the patients have for their limb. It is imperative to select those cases in which at least either the hip abductors or the knee extensors re- main intact. Lack of these muscles produces a poor functional result as the patient cannot control their limb. Lack of the quadriceps will place an undue strain on the hinge mechanism since the patient walks with a passive extension gait which may lead to early failure. If complete excision of the quadriceps is indicated, we recommend arthrodesis with a custom-made endoprosthesis cemented into the tibial shaft, particularly if the hip abductors are also compromised.

There are several advantages of the KMFTR system. The endoprosthesis is modular and easy to assemble during the operation, so the problems of using custom-made prostheses are avoided. The knee functions well postoperatively. The bipolar hip is easier to insert than a conventional ace- tabular socket; it is inherently more stable [13], and better than the Austin Moore type of prosthesis with regard to long term wear. We have had no

H. G. Morris et al.: Modular endoprostheses following femoral resection for malignancy 95

postoperative dislocations with this system. The tibial part has produced very good radiological results. None of our patients has needed long term bracing.

We are concerned about the polyethylene bush in the knee hinge; the average time to failure in this, and in another larger series, has been 64 months. Revision is a minor procedure, but carries a risk of infection, although this has not occurred in our experience. In one case, the screw in the connecting piece came undone, but this should be avoided by keeping the screws dry during their insertion and driving them home with as much power as possible.

We believe that reattachment of the abductor mechanism to a metal endoprosthesis is un- satisfactory as most patients have a Trendelenburg gait afterwards. The best arrangement is to use a composite allograft endoprosthesis and attach the abductors to the soft tissues of the allograft [3]. This is a difficult proposition when using the KMFTR, so we now sew the muscles to the tensor fascia lata which gives fair results with regard to the gait.

Previous papers have reported variable results and most show a high complication rate, so this procedure should only be considered when the alternative is disarticulation at the hip; the patient must be warned of the potential risks of re- construction.

We emphasise again the importance of main- taining the proximal and distal muscles if good or excellent results are to be achieved.

Acknowledgement. This work was supported by C.N.R (Consiglio Nazionale Ricerche A.C.R.O) funds, progetto

References

1. Buchanan J (1965) Total femur and knee joint replacement with a vitallium prosthesis. Bull Hosp Jt Dis 26 :21-34

2. Capanna R, Ruggieri R Biagini R et al (1986) Subtotal and total femoral resection: an alternative to total femoral prosthetic replacement. Int Ortho 10: 121-126

3. Delepine G (1992) Reconstruction totale du f6mur apr~s son ex~r~se pour sarcome osseux. In: Tomeno B (ed) Cours Sup6rieur Annuel de l'H6pital Cochin

4. Engelbrecht E, Engelbrecht H (1974) Totalersatz des Fe- inures unter Verwendung der Hfift- und Kniegelenkstotal- endoprothesen, Modell "St Georg". Chirurg 45:23 l - 236

5. Enneking W (1987) Modification of the system for func- tional evaluation of surgical management of musculoske- letal tumours. In: Enneking WF (ed) Limb salvage in musculoskeletal Oncology. Churchill Livingstone, New York, pp 626-639

6. Enneking W, Spanier S, Goodman M (1980) A system for the surgical staging of musculoskeletal sarcoma. Clin Or- thop 153:106-120

7. Katznelson A, Nerubay J (1980) Total femoral replacement in sarcoma of the distal end of the femur. Acta Orthop Scand 51:845-851

8. Kotz R, Ritschl R Trachdenbrodt J (1986) A modular femur and tibia reconstruction system. Ortopaedics 9: 1639-1652

9. Lavoie G, Healey JH, Lane JM, Marcove RC (1991) Prosthetic total femur replacement following massive re- section for sarcoma. In: Brown KLB (ed) Complications of limb salvage. ISOLS, Montreal, pp 129-132

10. Marcove R, Lewis M, Rosen G et al (1977) Total femur and total knee replacement. Clin Orthop 126: 147-152

11. Nerubay J, Katznelson A, Tichler T et al (1988) Total fe- moral replacement. Clin Orthop 229: 143-148

12. Neider E (1989) The saddle prosthesis mark II, endo- modell. In: Yamamuro T (ed) New developements for limb salvage in musculoskeletal tumours. Springer, Berlin Hei- delberg New York, pp 481-490

13. Ottolenghi C (1966) Massive Osteoarticular bone grafts: transplant of the whole femur. J Bone Joint Surg [Br] 48: 646-659

14. Rock M (1989) The use of bateman bipolar proximal fe- moral replacement in the management of proximal femoral metastatic disease. In: Yamamuro T (ed) New develop- ments for limb salvage in musculoskeletal tumours. Springer, Berlin Heidelberg New York, pp 437-442

15. Ritschl R Braun O, Pongracz N, Eyb R, Ramach W, Kotz R (1987) Modular reconstruction system for the lower ex- tremity. In: Enneking WF (ed) Limb salvage in muscu- Ioskeletal oncology. Churchill Livingstone, New York, pp 237-243

16. Steinbrink K, Engelbrecht E, Fenelon G (1982) The total femoral prosthesis: a preliminary report. J Bone Joint Surg [Br] 64:305-312

17. Steinbrink K (1986) Total femur replacement and the Saddle prosthesis. Bone tumour management. Butter- worths, London, pp 159-165

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