The use of polyglactin 910-polydioxanon in the treatment of defects of the orbital roof

The use of polyglactin 910-polydioxanon in the treatment of defects of the orbital roof

J Oral Maxlliofac 57~1301-1305. Surg 1999 The Use of Polyglactin 91&Polydioxanon in the Treatment of Defects of the Orbital Roof WolJgang P. Piotro...

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J Oral Maxlliofac 57~1301-1305.

Surg 1999

The Use of Polyglactin 91&Polydioxanon in the Treatment of Defects of the Orbital Roof WolJgang

P. Piotrowski,

MD, * and Ursula Mayer-Zuchi,

MDf

This study evaluated the use of polyglactin 910-polydioxanon (PPP) for repair of orbital roof

Purpose:

defects. and Methods: Between 1988 and 1996, 144 patients treated in the Department of Neurosurgery, Christian-Doppler-Medical-Center Salzburg, were operated on transcranially for fractures of the orbital roof or intraorbital tumors. In 85 of these 144 patients, PPP was used for reconstruction of the orbital roof or closure of the periorbita. The postoperative results in patients in whom the PPPpatch was used for reconstruction of the orbital roof were compared with the results of a group treated without PPP. Patients

Even in severely injured patients, the reconstruction was judged to be very good in 71 patients

Results: (83.5%).

PPPis a useful material for the reconstruction of the orbital roof.

Conclusion:

Defects of the orbital roof mostly occur in connection with traumatic injuries of the midface or anterior fossa of the skull base, or from tumors of the orbit or surrounding structures. Depending on the severity, such defects of the orbit may require reconstruction. This treatment should be included in the management of frontobasal fractures and after tumor extirpation to avoid a second operation. In addition, reconstruction may be mandatory after transcranial approaches to the orbit. The treatment should be coordinated among the ophthalmologist, the oral and maxillofacial surgeon, and the neurosurgeon.’ The aim of the treatment is primary reconstruction of the natural volume of the orbit and its contours to prevent possible enophthalmus and disturbances of motility.2 Depending on their extent, defects of the orbital roof can lead to the following disturbances: damageto the contour of the orbit; impairment of the superior rectus muscle by bone fragments; ptosis caused by irritation of the levator muscle; changes in the volume of the orbit leading to exophthalmus or enophthalmus, which can be accompanied by pulsations that

Received

from the Department

Medical-Center

Salzburg,

of Neurosurgery,

Christian-Doppler-

Austria.

*Neurosurgeon. tResident. Address Department burg,

correspondence

and reprint

of Neurosurgery,

Ignaz-Harrerstrase

requests

to Dr Piotrowski:

Christian-Doppler-Medical-Center 79,

A-5020

Salzburg,

Austria;

Salze-mail:

[email protected] D 1999 American Association of Oral and Maxillofacial 027%2391/99/571

Surgeons

l-0005$3.00/0

1301

are passedon by the frontal lobe in some cases;a shift of the contents of the orbit intracranially; lesions of the optic nerve when the fractures extend to the roof of the optic canal; and formation of a hematoma or compression by a bone fragments,* The connection of defects of the orbital roof and the paranasal sinuses,especially in the presence of a dural lesion, can promote septic complications such as infection of the orbit and meningitis or cerebral abscesses. 1,j,6Epiphora can be induced by an obstruction of the nasolacrimal duct or feigned by a leakage of cerebrospinal fluid (CSF).7sIndependent of the pathology, the aims of operative therapy of orbital roof defects are restoration of the former orbital volume and stable fixation9s10 Reconstruction of the orbital roof not only makes it possible to gain a cosmetic improvement, but also a better functional result. This helps to prevent tedious secondary operations, which would be necessary to correct disturbances of eye motility and exophthalmus or enophthalmus. Finally, the risk of infection is reduced with primary treatment. It is not always possible to reestablish the orbital contour in its original form because the very small fracture fragments do not allow proper stabilization, or there has been removal of parts of the orbit because of the operative approach or radical tumor removal. In such cases, reconstruction with autologous bone or synthetic materials is necessary. Among the suitable synthetic materials are polydioxanon implants (PDS, Fa. Ethicon, Hamburg, Germany) or polyglactin 910polydioxanon (PPP) implants (Etisorb, Fa. Ethicon). With the latter implants, resorption of the polyglactin 910 is finished after 60 days, and resorption of the

1302

ORBITAL

polydioxanon component, which is in the ratio of 7: 1, is finished after 184 days. l1 The osseous regeneration of the orbital defect, which starts from the bony margins, is supported by the activated periosteal membrane, and the resorbed implant will be replaced by tight scar tissue, which has no attachment to the orbital contents. The implant allows bridging of even large defects and avoids a prolapse of the contents of the orbit with ensuing enophthalmus. l2 The purpose of this study was to obtain information on the compatibility, possible late complications, and the stability or contourability of polyglactin 910polydioxanon used for orbital roof reconstruction.

Patients

and

70

1

61

GOSl

Gos2

GOs3

Gos4

Goss

1. Neurologic outcome (GOS), n = 144 (group I, n = 85; group II, n = 59). q Group I: patients in whom PPP was used; W Group II: patients in whom PPP was not used. Grade I, death; grade II, persistent vegetative state; grade Ill/ severe disability [conscious but disabled, dependent on daily support]; grade IV, moderate disability [disabled but independent); grade V, good recovery (resumption of normal life).

CONSTRUCTION

Group I* (n

= 85)

Group IIt (n = 59) n %

Reasons

Procedure

n

%

Traumatic injuries

Closure of periorbita Reconstruction of orbital roof Reconstruction and stabilization of orbital roof Reconstruction of orbital roof Reconstruction and stabilization of orbital roof Reconstruction and stabilization of orbital roof Total

11

12.9

22

25.9

37

62.7

37

43.6

21

35.6

11

12.9

1

1.2

3

3.5

Tumor

Methods

In the period between January 1, 1988 and December 31, 1996, 144 patients with lesions of the orbital roof were operated on in the Department of Neurosurgery, Christian-Doppler-Medical-Center, Salzburg, Austria. In 85 (59%) patients, a reconstruction with a polyglactin 910-polydioxanon patch (PPP, Etisorb) was performed. Figure 1 shows the distribution of the patients’ age and sex. The main causes of the defects were fractures (70 patients, 82.3%; Table 1). In injuries to the orbit, PPP was used either alone for reconstruction (n = 22) or in connection with stabilization using miniplates (n = 37). PPP also was used for closure of prolapsed periorbita to prevent extrusion of intraorbital fatty tissue, as well as for reconstruction of the orbital roof in all cases of tumor surgery. The procedures in which PPP was used are listed in Table 1. To assess late complications, it is necessary to wait until the implant material is completely resorbed (6

ROOF

Functional disorder

*Group tGroup

85

100

1 59

1.7 100

I: Patients in whom PPP was used. II: Patients in whom PPP was not used.

months) and any change in the connective tissue can be excluded. Therefore, the follow-up period in this study averaged 49.5 months (shortest follow-up, 8; longest, 420 months), a period longer than the resorption time.l’ The results of treatment were evaluated by means of computed tomography scans or magnetic resonance imaging and clinical examination. The result with reference to the orbit and its contents was classified as very good (no functional or cosmetic sequelae), good (minor functional or cosmetic sequelae, which never lead to disability in normal life), satisfactory (minor functional or cosmetic sequelae associated with moderate disability), and poor (functional or cosmetic sequelae that needed further intervention). The patient’s postoperative neurologic condition was classified using the Glasgow Outcome Scale (GOS).12 The results of the treatment of patients in whom PPP was used (group I) were compared retrospectively with those in 59 patients in whom PPP was not used (group II), but who otherwise were treated according to the same guidelines. The latter patients were reconstructed with either homologous, lyophilized costal cartilage3 or autologous bone from the inner table of the bone flap of the craniotomy or from the iliac crest.

FIGURE

Results Of the 85 patients treated surgically with PPP (group I), 7 died (8.2%). The causes of death were the

PIOTROWSKI

80 70-

1

AND

1303

MAYER-ZUCHI

71 -

60 50 40 30 20 10 -

6

6

7

6

0 I very good

good

satisfactory

Poor

death

FIGURE 2. Result of reconstruction of the orbital roof, n = 144 [group I, n = 85; group II, n = 59). 0 Group I: patients in whom PPP was used; n Group II: patients in whom PPP was not used. Very good, no functional or cosmetic sequelae; good, minor functional or cosmetic sequelae without disabiliv; satisfactory, minor functional or cosmetic sequelae with moderate disability; poor, functional or cosmetic sequelae that needed further intervention death.

consequences of concomitant injuries or in the case of 1 patient an ischemic stroke after tumor surgery. Of the patients treated without PPP (group II, n = 59) 6 did not survive (10.2%, Fig 1). In this group, the causes of death were also the consequences of concomitant injuries and, in 1 case, a pulmonary embolism. The neurologic results in both groups were evaluated by the GOS and are shown in Figure 1.ls In 71 patients in group I (83.5%), the operative result was very good, which meant that they were

without functional or cosmetic sequelae(Figs 2-4); in this classification, cerebral complications such as CSF leak and internal hydrocephalus were not considered. In no case was a rejection of the material noted. The decreased number of patients with very good results in group II (n = 40, 67.8%) was due to the type of primary injury. Fourteen patients in group I (16.5%) and 19 patients in group II (32.2%) showed complications due to the primary traumatic injury of the orbit or its contents (Table 2). All complications appeared to be due to the primary injuries and not to the method of treatment (Tables 2, 3). The postoperative results after reconstruction of the orbit following tumor extirpation or a functional disorder were very good (Fig 3). Poor results were found only in patients with traumatic lesions. Some patients who had complications from the primary injury could not be improved with further operations, the result appearing to be independent of the material used. In 11 patients (12.9%) in whom PPPwas used, 15 postoperative complications or unsatisfactory functional or cosmetic results occurred that required further intervention (Table 3). A revision due to persistent eye motility disturbances caused by the original injury had to be performed in 6 patients (7.1%) which still resulted in permanent impairment in 1 patient. Ten patients (16.9%) in group II also needed further operations, 5 of these (8.8%) because of eye motility disturbances. Even though 57 patients (67.1%) in group I had an

FIGURE 3. Patient 1 39, a 22year-old woman. ‘A, Coronal Tl -weighted MRI with gadolinium showing a tumor of the roof and the medial wall of the right orbit. The patient suffered from increasing exophthalmus and diplopia for 2 years. 6, Coronal CT scan 7 days after extirpation of a psammomatous desmo-osteoblastoma of the roof and the medial wall of the right orbit. The orbital roof and parts of the medial wall of the orbit were reconstructed with a polyglactin 9lO-polydioxanon patch [arrows]. Three weeks after the operation, the patient had no residual problems.

1304

ORBITAL

ROOF CONSTRUCTION

FIGURE

4. Patient 152, a 22year-old man. A, Axial CT scan showing a dislocated fracture of the left orbital roof on the day of admission. In addition, the patient suffered from polytrauma with head injury, a left fronto-basal fracture, and open fractures on both lower limbs. 5, Coronal CT scan 7 days after the operation, which was performed 6 days after the injury, showing the orbital roof reduction stabilized with miniplates. Parts of the orbital roof and the medial orbital wall were reconstructed by a polyglactin 910-polydioxanon patch (arrows]. The patient had no residual problems.

open head injury, postoperative wound infections did not occur. One patient suffering from a persistent CSF leak had meningitis that was treated successfully with antibiotics. The number of patients with open head injury in group II was 52 (88.1%); postoperative wound infections also did not occur in this group.

Discussion The advantages of using synthetic materials are the simplification of the procedure and the reduction in

Complications Restrictionof globemotility Enophthalmus Lesionof optic nerve (reduction of vision) Lesion of optic nerve (loss of vision) Lesion of oculomotor nerve Diplopia Injury of globe (reduction of vision) Injury of globe (loss of vision) Total Number of patients with comphcations *Group i-Group

Group I* (n = 85) % n

Group IIt (n = 59) n %

1

1.2

5

8.5

3

3.5

5

8.5

5

5.9

1

1.7

2 2 3

3.9 3.9 5.1 3.9 3.9 37.3 32.2

3 3

3.5 3.5

15

17.6

2 2 22

14

16.5

19

I: Patients in whom PPP was used. II: Patients in whom PPP was not used.

operating time by avoiding the removal of autologous bone or cartilage and the avoidance of a second operative site. The contourability of these materials is an additional benefit in orbital roof reconstruction. A comparison of the operative results in patients (Table 2) in whom PPPwas used for reconstruction of the orbital roof and those in whom PPPwas not used showed, in our opinion, that problems that occurred were a result of the primary injury. In the 144 patients, none of the complications were due to the use of PPP. The complications noted were either complications caused by the head injury, its sequelae (hydrocephalus, for example), or primary orbital injury, such as motility disturbances due to loss of fatty tissue and enophthalmus. No complication such as infection or loss of stability could be attributed to the procedure used in either group.

Group I* Complications Cerebrospinal fluid leak Disturbance of eye motility Internal hydrocephalus Hematoma of optic nerve sheath Total Number of patients with second operation *Group tGroup

Group IIt

(n = 85)

(n = 59)

n

%

n

6 6 3

7.1 7.1 3.5

4 5 2

6.8 8.8 3.9

15

17.6

1 12

20.3

11

12.9

10

16.9

I: Patients in whom PPP was used. II: Patients in whom PPP was not used.

%

1.7

GEORGE

M.

1305

KUSHNER

The literature available on orbital floor implants does not report late complications with biodegradable materials, in contrast to the use of nonresorbable alloplastic materials. 14,15In our study, neither early nor long-term problems could be observed during an average follow-up period of 49.5 months. With very large defects, it is preferable in some casesto use autologous bone for reasons of contourability. PPP seemshighly appropriate for reconstruction, especially after tumor extirpation or isolated injuries of the orbital roof. Basedon our experience, it can be concluded that PPPis useful for reconstruction of the roof of the orbit, not appearing to increase the number of complications, and that it can, at least partially, replace autologous grafts.

4. 5. 6.

7. 8. 9. 10.

11,

12.

References 1. Piotrowski WP: The primary treatment of frontobasal and midfacial injuries in patients with head injuries. J Oral Maxillofat Surg 50:1264, 1992 2. Rubin PAD, Shore JW, Yaremchuk J: Complex orbital fracture repair using rigid fixation of the internal skeleton. Ophthalmology 99~553, 1992 3. Beck-Mannagetta J, Piotrowski WP: Zur operativen Versorgung

J Oral

Maxlllofac

13. 14. 15.

von LHsionen des Orbitadaches, in Waldhart E (ed): Traumatologie des Mittelgesichtes. Stuttgar, Thieme, 1991, p 218 Mauriello JA Jr: Complications of the orbital trauma surgery. Adv Ophthalm Plast Reconstr Surg 7:99, 1988 McLachlan DL, Flanagan JC, Shannon GM: Complications of orbital roof fractures. Ophthalmology 89: 1274, 1982 Silver HS, Fucci MJ, Flanagan JC, et al: Severe orbital infection as a complication of orbital fractures. Arch Otolaryngol Head Neck Surg 118:845, 1992 Beyer CK, Fabian RL, Smith B: Naso-orbital fractures, complications and treatment. Ophthalmology 89:456, 1982 Dryden RM, Wulc AE: Pseudoepiphora from cerebrospinal fluid leak: Case report. Br J Ophthalmol70:570, 1986 Pearl RM: Treatment of enophthalmus. Clin Plast Surg 19:99, 1992 Piotrowski WP, Beck-Mannagetta J: Surgical techniques in orbital roof fractures: Early treatment and results. J Craniomaxillofac Surg 23:6, 1995 Guthoff R, Wagner T, Holste J, et al: Resorbierbare Plombernmaterialien in der Amotiochimrgie. Klin Monatsbl Augenheilkd 202:43, 1993 Merten HA, Luhr HG: Resorbable synthetics (PDS foils) for bridging extensive orbital wall defects in an animal experiment comparison (in German). Fortschr Kiefer Gesichtschir 39: 186, 1994 Jenett B, Bond H: Assessment of outcome after severe brain damage. Lancet 1:480, 1975 Brown AE, Banks P: Late extrusion of alloplastic orbital floor implants. BrJ Oral Maxillofac Surg 31:154, 1993 Stewart MG, Patrinely JR, Appling D, et al: Late proptosis following orbital floor fracture repair. Arch Otolaryngol Head Neck Surg 121:649,1995

Surg

57: 130.5-l 306,

1999

Discussion The Use of Polyglactin 9 1 D-Polydioxanon in the Treatment Defects of the Orbital Roof George

M. Kushner,

DMD,

of

MD

Associate Professor, Oral and Maxillofacial Director, Advanced Education Program Surgery, Surgical and Hospital Dentistry, School of Dentistry, Louisville, Kentucky; gmkushO1 @gwise,louisville.edu

Surger in Oral an cr Max~llofacial Proaram University of Louisville, e-mail:

The authorsof this article present a technique of orbital roof reconstruction using resorbable materials. Interestingly, the literature has been extensive on the subject of orbital floor reconstruction but there appears to be less interest in orbital roof reconstruction.1-3 A multitude of materials are available for orbital reconstruction. These include: autogenous grafts of bone cartilage or fascia; nonresorbable implants such as silicone rubber, polyamide, titanium and Vitalium mesh, hydroxylapatite blocks, and porous polyethylene; and resorbable implants of Vicryl mesh, gelatin film, and a polylactic-polyglycolic copolymer. It is obvious that with this many choices, the “perfect” material for orbital reconstruction has yet to be found.‘” The “gold standard” for orbital reconstruction is an autogenous cranial bone graft. The bone is easily accessible,

plentiful, and has a low resorption rate, especially when rigidly fixed.* Surgeons and patients seem to favor the idea of “using the patient’s own tissue to reconstruct the patient.” This popular trend seems to come from recent disasters with the use of Teflon-Proplast temporomandibular joint (TMJ) implants and silicone breast implants. The disadvantage of this technique is the increased operative time used in obtaining and contouring the cranial bone grafts, along with the inherent morbidity of the procedure. There are several reports of surgical misadventures with disastrous sequelae.5

Reconstructionof the orbit with an implant can certainly cut down on operative time and decrease the morbidity of a second surgical site. However, issues of tissue compatibility, implant strength, retrievability, and infection have always been a clinical concern. A variety of implant materials have been used for orbital reconstruction, each with its own advantages and disadvantages. 1 We are still searching for the ideal alloplastic material. There has been a great interest in resorbable materials, for example, plates, screws, and mesh panels, in craniomaxillofacial surgery. These devices are rigid enough to allow bony healing and yet totally resorb over a relatively short period. The literature contains many articles and reports with regard to use of resorbable fixation in craniomaxillofacial surgery, primarily in the pediatric patient group. As a result