BIODEGRADABLE INTERNAL FIXATION FOR MALLEOLAR FRACFURES

A PROSPECTIVE
0. BOSTMAN, S. VAINIONPAA,

RANDOMISED
E. HIRVENSALO,

TRIAL
A. MAKELA,

K. VIHTONEN,

P. TORMALA,

p. ROKKANEN

From the University Central Hospital, Helsinki, Finland, and the University of Technology,Tampere Fifty-Six patients with displaced malleolar fractures had open reduction and fixation of the fracture fragments using, by random selection, either biodegradable implants or metal AO plates and screws. The cylindrical biodegradable implants were made of polylactideglycolide copolymer (jolyglactln 910). The complications, radiographic results and functional recovery were studied prospectively. After follow-up of at least one year, no significant differences emerged in the complication rate or in the results of treatment between the two methods of fixation. Because of the advantage of avoiding the need to remove metal fixation after union, we now use biodegradable internal fixation routinely to freat displaced malleolar fractures.
Several biodegradable synthetic polymers have been
Table I. Criteria for eligibility and for exclusion from the series Eligible Age between 16 and 70 years Closed fracture of the lateral malleolusor of both the medial and lateral malleoli Displacement of 2 mm or more ofthe fragments or ofthe talus Excluded An associated fracture involving the articular surface of the posterior tibial margin
High fibular fracture with rupture of the distal tibiofibular

used as absorbable sutures for some years. These include polyglycolic acid, polydioxanone and the copolymer of polylactid acid and polyglycolic acid. The use of such
biodegradable materials for the internal fixation of

fractures would avoid the need for later removal of the implant, but the development of suitable implants has proved difficult (Sedel et al. 1978; Hollinger and Battistone 1986). Promising results have recently been obtained with
synthetic biodegradable polymers as tendon replace

syndesmosis Other clinically significant injuries Medical contraindications to anaesthesia and surgery
Psychiatric disorder or alcoholism which could reduce co

ments (Howard, McKibbin and Rli@1985), in a resurfacing arthroplasty cup (Wedge et al. 1986) and as rods for the fixation of osteochondral fragments or
osteotomies (Greve and Holste 1985 ; VainionpaA et al.

operation

1986). A number of research groups are studying the application of biodegradable implants in orthopaedic surgery but, as yet, no follow-up studies on the use of these implants in the treatment of common fractures have been published. We report a prospective rando

mised trial in which the results one year after biodegra dable fixation were compared with those of conventional metal implants in displaced fractures of the ankle.

0. Bostman, MD, Orthopaedic

Surgeon

PATIENTS AND METHODS Design of the study. From November 1984 all patients with displaced malleolar fractures admitted to the Department of Orthopaedics and Traumatology, Helsin ki University Central Hospital, were considered for the study by the strict application of criteria for eligibility and exclusion (Table I). The diagnosis was made from standard anteroposterior, mortise view (limb 200medial
ly rotated) and lateral radiographs. Fractures with less

S. VainionpaA,MD, Orthopaedic Sur@eon

E. Hirvensalo, MD, Orthopaedic Registrar A. MAkela, MD, Orthopaedic Surgeon

IC Vihtonen, MD, Orthopaedic Registrar

P. Rokkanen, MD, Professor and Director

Department of Orthopaedics and Traumatology, University Central Hospital, Topeliuksenk. 5, SF-00260 Helsinki, Finland.
P. TrmAlA, PhD, Professor

Biomaterials Laboratory, University of Technology, POB 527, SF 33101 Tampere, Finland.

Requests for reprints should be sent to Professor P Rokkanen.

0301620X/87/4162 $2.00

1987BritishEditorialSocietyof Boneand Joint Surgery

than 2 mm initial displacement were managed non operatively, as has long been our policy.
615

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0. BOSTMAN,

S. VAINIONPAA,

E. HIRvENSAL0,

ET AL.

All patients who met the criteria and gave informed

consent were randomly allocated to two treatment

al. 1985) from polylactide-glycolide copolymer (polyglac tin 910). The behaviour of this polymer had previously

groups, one treated with biodegradable implants and the other with metallic internal fixation according to standard AO techniques, using a one-third tubular
neutralisation plate for the lateral malleolus and one or

beenthoroughlyinvestigatedin connectionwith its use

as an absorbable suture, Vicryl (Craig et al. 1975). The implants were moulded from polylactide-glycolide co
polymer using fibres of the same composition as a

two cancellous lag screws for the medial malleolus (Muller et al. 1979). The management of the two groups was otherwise identical. All operations were performed by the authors as emergency procedures using a tourniquet, and in most cases, under spinal anaesthesia. A below-knee padded and split plaster was applied after wound closure and the patient was allowed to move around on crutches the following day, leaving hospital on the third or fourth postoperative day. Patients were reviewed clinically and radiographically at three, six, nine and 12 weeks and after six and 12months. Partial weight-bearing started at
three weeks, full weight-bearing at four weeks, and the

reinforcement and wereusedascylinder-shapedrods, 3.2 or 4.5 mm in diameter and 50 or 70 mm in length. The clinical study had been preceded by extensive experi mental research (Vainionpaet al. 1986).
Longitudinal incisions over the malleoli were used

(Weber 1972) and after reduction, channels were drilled across the fracture surfaces from the tips of the malleoli. Polylactide-glycolide rods were driven into these chan nels (Fig. 1); for the lateral malleolus one 4.5 mm by 70 mm rod was used, while for the medial malleous, depending on the size of the fragment, either one or two
3.2 or 4.5 by 50 mm rods were inserted and the fixation

reinforced by polylactide-glycolide sutures (see Fig. 1). RESULTS Of the 60 patients that entered the trial one suffered a fracture of the cervical spine with tetraplegia five months after the ankle fracture and three patients were lost to follow-up. Thus one-year follow-up was complete for 56 patients, 28 in each of the biodegradable and metallic fixation groups. The mean age of the patients in the two groupswas 38.3and 41.6 yearsrespectively with male to female ratios of 0.7 : 1 and 1.1 : 1. By Lauge Hansen's 1952 classification, 54 fractures were of the supination-eversion type (Figs 2 and 3) and two were of the supination-adduction type. In the Weber (1972) classification, 53 were Type B and three Type A. The mean displacement of the lateral malleolar fragment

plaster cast was discarded at six weeks. No formal physiotherapy was offered. Those with metallic fixation had the plates and screws removed after 6 to 10 months. The study was designedto include 60 patients, each treatment group comprising 15 patients with a fracture of the lateral malleolus and 15 with a bimalleolar fracture. The last patient entered the study in October 1985. Record was kept of the reduction and retention of position, of complications and of functional recovery. At one-yearfollow-up a functional scoring scale(Olerud and Molander 1984) was used. Biodegradable implants. The biodegradable implants were developed at the authors' institutions (Rokkanen et

beforeoperationin thebiodegradable groupwas3.3mm

(range 2 to 9 mm) and in the metallic fixation group 3.4 mm (range 2 to 11 mm). Reduction and retention of fractures. The immediate postoperative radiographs showedexact reduction in 25 patients with biodegradable fixation and in 26 with metallic fixation, while of the other five patients the residual displacement in four was only 1 mm. One bimalleolar fracture with biodegradable fixation was poorly reduced because of unexpected comminution in very osteoporotic bone. The initial reduction was maintained until union in 51 ofthe 56 patients. In two ofthe biodegradable and one
Fig. 1 Diagram of the surgical technique using biodegradable implants. The cylinder shaped polylactide-glycolide rods are driv en through channels drilled in the cancel bus bone across the fracture surfaces. The fixation is reinforced on the lateral side by
. a figure-of-eight polylactide-glycolide su

of

the

metallic

fixation

group

secondary,

minimal

ture from holes in the distal fragment

the fibresof the distal tibiofibularSyndes

mosis. On the medial side the periosteum is sutured to cover the fracture line.

to

displacement of the lateral malleolar fragment was seen at three weeks. Of clinical significance, one patient with biodegradable fixation showed a 7 valgus tilt of the lateral malleolus at three weeks and one patient with metallic fixation showed gradual development of tibio fibular diastasis probably as a result of undiagnosed rupture of the distal tibiofibular syndesmosis(Table II).
Complications. In both groups there was a disturbance of

THE JOURNAL OF BONE AND JOINT SURGERY

BIODEGRADABLEINTERNAL FIXATION FOR MALLEOLARFRACTURES

617

Fig. 3 Figures 2 and 3. A displaced supination-eversion bimalleolar fracture ofWeber Type B. Figure 2 On admission. Figure 3 At 12 weeks the fracture, treated by biodegradable fixation, has united.

There were two refractures due to a new accident in the metallic fixation group, one before and the other after infection caused by Staphylococcus aureus. Two patients removal of the implants (Table II). with biodegradable implants developed a wound sinus Functional recovery. The mean duration of sick leave three to four months after the operation and uneventful after biodegradable fixation was 65 days. After metallic initial wound healing. Wound swabs showed no bacterial fixation it was 67 days for the primary operation plus an growth ; healing followed minor draining proceduresand extra 8 daysfor implant removal. The functional result at the ultimate functional recovery was not influenced. one-year was assessed as excellent in 21, good in five and fair in two patients of the biodegradable group. In the wound healing in two patients. After metallic fixation
these were early and consisted of superficial wound
Table II. Clinically significant complications groupBiodegradableMetalUnsatisfactory Treatment

metallic

fixation group the result was excellent

in 20,

good in seven and fair in one patient. There were no poor results. The three patients with less than good results were the same three that showed clinically significant malunion (Table II). DISCUSSION This randomised trial has shown that, for the selected types of displaced malleolar fracture, the anatomical and functional results of biodegradable fixation and of conventional osteosynthesis with metal are equal. The practical significance of this finding depends on the
resources and time used in removing metal implants. Displaced malleolar fractures are common injuries, and

initial reductionIFailure of fixation and secondary displacement11Disturbance of wound healing22Refracture2*None2424Total2828

* One

patient

had

both

wound

infection

and

refracture

the functional results are strongly correlated with anatomical reduction (Klossner 1962; Solonen and

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0. BOSTMAN,

5. VAINIONPAA,

E. HIRVENSALO, ET AL.

Fig. 4

Fig. 5

Fig. 6

CTscansoftheleftankleofa 53-year-old womanwhohada displaced bimalleolar fracture.Figure4 Sixweeksafter

reduction and fixation with biodegradable implants. The rods, 4.5 mm in diameter, are seen to be radiopaque in their drill channels. Figure 5 - Five months later the opacity of the rods has markedly decreased as a result of advancing hydrolysis. Figure 6 After one year the channels look empty and are surrounded by new bone formation.

Lauttamus 1968; Pettrone et al. 1983; Tunturi et al. 1983; Phillips et al. 1985). Consequently, despite reports
of successful closed treatment (Kristensen and Hansen

1985; Rowley, Norris and Duckworth 1986), displaced fractures of the ankle are very commonly managed by open reduction and internal fixation. The AO school recommend that metallic implants be removed in due course, to restore normal biomechanical forces on bone (Weber 1972; Muller et al. 1979), but in different units the policy may vary from routine removal to routine retention. Since malleolar fractures affect only cancel
bus bone the adverse effect of stiff metallic implants diaphyseal fractures on

The shape of the biodegradable implant, a simple cylinder, is unsophisticated. However, considerable chemical and technical problems will have to be overcome before it will be possible to manufacture a screwfrom biodegradablepolymer which can be usedfor limb fractures, though screws made of polydioxanone have already been used in surgery of the mandible (Niederdellmann and Bhrmann1983). In anticipation of wider clinical application in orthopaedic surgery several experimental studies have been made on the biodegradable pin fixation of osteochondral fragments (Gay and Bucher 1985; Greve and Holste 1985; Claes et
al. 1986), a particularly useful indication. Another

the remodelling of bone is of less significance than in

(Tayton and Bradley 1983). In the

ankle, however, the usual reason for the removal of metal is the inconvenience and discomfort produced by plates and screws directly under the skin. Biodegradable fixation may be insufficient for severely comminuted fractures in osteoporotic bone, but the failure of fixation and subsequentlossof reduction is probably associated, as after osteosynthesis with metal, with the patient's inability or unwillingness to avoid weight-bearing during the first postoperative weeks. The degradation time of copolymer within the body by hydrolysis is estimated to be between 60 and 100 days (Hollinger and Battistone 1986), which should be long enough to hold fractures in cancellous bone until union has taken place (Figs 4 to 6). The two cases with disturbance ofwound healing had sinus formation rather than infection, and the frequency of this phenomenon (7.1%) was close to that of a similar complication seen after closure of abdominal incisions with Vicryl (Gam melgaard and Jensen 1983). The complication rate in the group with metallic fixation was much the same as those
recorded in two recent studies on ankle fractures (Bauer et al. 1985; Mak, Chan and Leung 1985).

approach to the problem of intra-articular fixation is the use of adhesives, but as yet the bonding strength of biodegradable adhesivesseemsinadequate for fracture
fixation (Weber and Chapman 1984). There is also,

among the sparse literature on non-metallic internal fixation, a short report by Merendino, Sertl and Skondia (l984)on the wide clinical use in the Soviet Union of rods made ofpolyvinyl-pyrrolidone and methyl methacrylate. These partially absorbable implants are termed biocompatible. The results of our study show that biodegradable implants, although still under development, can be used successfully in certain ankle fractures. We deliberately chose simple types of malleolar fracture because of our lack of experience, but displaced uni- and bi-malleolar fractures are now routinely treated by biodegradable
fixation in our department. A total of nearly 200 patients

have been treated by this method ; further applications of biodegradable fixation both in fracture fixation and in other fields of orthopaedic surgery are being investigated.
This investigation has been supported by the Academy of Finland. THE JOURNAL OF BONE AND JOINT SURGERY

BIODEGRADABLEINTERNAL FIXATION FOR MALLEOLARFRACTURES

REFERENCES internalfixation:

619

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