- Email: [email protected]
Preliminary Results of a Prospective Study on Methods of Cranial Reconstruction
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56
CRANIOMAXILLOFACIAL TRAUMA
Preliminary Results of a Prospective Study on Methods of Cranial Reconstruction Q7 Q2
Corrado Iaccarino, MD,* Edoardo Viaroli, MD,y Marco Fricia, MD,z Elena Serchi, MD,x Tito Poli, Prof,k and Franco Servadei, MD{ Purpose:
Given its biological and anatomic features, autologous bone is the first choice for cranioplasty after bone decompression. When autologous bone is not available or must be replaced, surgeons can choose among various materials to create an alloplastic cranioplasty. The Italian Society for Neurosurgery promoted a prospective study conducted at 4 Italian neurosurgical units to compare different methods of cranioplasty and to assess the clinical results and incidence of complications.
Materials and Methods:
Patients older than 14 years who underwent repositioning of autologous bone or 3-dimensional image-guided reconstruction with prostheses made of an alloplastic material (polyetheretherketone, polymethylmethacrylate, or hydroxyapatite) after cranial decompression were enrolled prospectively from January 2008 through December 2013. The collected data included the material used to produce the prosthesis, the type of cranioplasty (primary or secondary), and complications that required surgical removal of the prosthesis (eg, infection, bone resorption, and fracture of the cranioplasty).
Results:
Ninety-six patients met the study criteria. Fifty cases were reconstructed with hydroxyapatite, 31 with bone, 13 with polymethylmethacrylate, and 2 with polyetheretherketone. Seven patients (7.3%) developed complications related to the cranioplastic implant that required reoperation. These complications included infection (4 cases), bone resorption (2 cases), and fracture of the cranioplastic prosthesis (1 case). Statistical analysis showed a higher rate of complications with the use of autologous bone versus alloplastic materials (P = .03). Owing to the limited number of cases, no statistically meaningful complication was seen among the different alloplastic materials or when the cranioplastic implant was placed as secondary treatment.
Conclusions: These data and those of other reports suggest that cranioplasty conducted using alloplastic 3-dimensional reconstruction materials have a lower rate of complications than those conducted using autologous bone. Ó 2015 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg -:1-4, 2015
There is an increasing need for reconstruction after cranial decompression from various pathologies. Cranial reconstructive surgery often involves maxillofacial surgeons, neurosurgeons, and plastic surgeons.
The gold standard for cranial reconstruction remains to be determined, and, overall, cranioplasties produce a high rate of complications. To date, many retrospective studies have compared different
*Staff Neurosurgeon, Neurosurgery-Neurotraumatology Unit,
Drs Iaccarino and Servadei received limited grants for educational
AOU Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy.
purposes from Codman Co. Dr Viaroli had a consultant role for
yStaff Neurosurgeon, Neurosurgery-Neurotraumatology Unit,
16 months at Finceramica.
AOU Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy. zStaff Neurosurgeon, Neurosurgery Unit, ‘ Cannizzaro’’ Hospital,
Address correspondence and reprint requests to Dr Iaccarino: Neurosurgery-Neurotraumatology Unit, University Hospital of
Catania, Italy.
Parma, Emergency Neurosurgery Unit, IRCCS ‘ASMN’’ of Reggio Emi-
xStaff Neurosurgeon, Neurosurgery Unit, IRCCS Neuroscience
lia, Viale Risorgimento, 80-42100 Reggio Emilia, Italy; e-mail:
Institute, Bologna, Italy.
[email protected]
kAssociate Professor, Maxillofacial Surgery Unit, AOU Parma,
Received May 15 2015
Parma, Italy.
Accepted July 10 2015
{Department Head, Neurosurgery-Neurotraumatology Unit, AOU
Ó 2015 American Association of Oral and Maxillofacial Surgeons
Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy.
0278-2391/15/01007-1 http://dx.doi.org/10.1016/j.joms.2015.07.008
1 FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112
113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
2
METHODS OF CRANIAL RECONSTRUCTION
materials used for cranioplasty to determine the main factors involved in the development of postoperative complications.1-3 To the authors’ knowledge, this study is the first prospective work with the same objective.
Materials and Methods DATA COLLECTION
Data from neurosurgical registries at 4 different hospitals in Italy (University Hospital of Parma, ASMN Reggio Emilia, Bellaria Hospital of Bologna, and Cannizzaro Hospital of Catania) were collected prospectively from 2008 through 2013. The study was approved by the local institutional review board and ethical committee of the principal investigator’s center at the start of the study. Patients eligible for the study underwent cranioplasties performed with 4 different materials: autologous bone that the patient donated from the previous surgery for decompressive craniectomy or bone removal that had been stored in an institutional bone bank (Istituti Ortopedici Rizzoli, Bologna, Italy), custom-made hydroxyapatite (HA), custom-made polymethylmethacrylate (PMMA), or custom-made polyetheretherketone (PEEK). The data collected included patient age, reason for bone removal (trauma, subarachnoid hemorrhage owing to rupture of an aneurysm, stroke, tumor, infection), material used to create the cranioplastic prosthesis, type of cranioplasty (primary or secondary), complications that required surgical reoperation, clinical follow-up data (evaluated with the extended Glasgow Outcome Scale), and radiologic follow-up data ($6 months; 11 7 months; Table 1). Patients younger than 14 years were excluded. The 4 centers involved prospectively shared the same database and the same clinical and radiologic follow-up data but did not specifically randomize patients to a specific treatment. STATISTICAL ANALYSIS
The patient population was divided into 2 groups, autologous bone or alloplastic prosthesis, which were compared using an odds ratio based on the need for a second operation. The same analysis was performed by comparing porous HA devices with synthetic material (PEEK and PMMA) used for cranioplasty and by comparing primary with secondary cranioplasty (performed after a complication).
Results Ninety-six patients met the study criteria: 31 underwent a cranioplasty with autologous bone, 50 with HA, and 15 with synthetic materials (13 with PMMA and 2 with PEEK). All alloplastic cranioplasties were
Q1
custom made using 3-dimensional computed tomographic reconstruction techniques. Clinical and radiological data are presented in Table 1. Among patients in the alloplastic cranioplasty group, 39 underwent placement of a primary cranioplasty (27 with HA and 12 with PMMA or PEEK) and 26 (23 with HA and 3 with PMMA or PEEK) underwent a secondary cranioplasty because of bone resorption (21 cases) or infection of a previous cranioplasty (5 cases). Seven patients developed complications related to the cranioplasty and required a second operation: 4 developed infections (3 in the autologous bone group and 1 in the HA group), 1 had a postoperative fracture of an HA prosthesis, and 2 had bone resorption. Custom-made PEEK and PMMA devices were not associated with any complications. The odds ratio showed a relation between the use of autologous bone and the development of major complications (P = .03710) compared with alloplastic materials. No meaningful difference was found for the comparison between different alloplastic materials or between primary and secondary cranioplasty. Furthermore, no meaningful difference was seen in the rate of hematomas after cranioplasty requiring surgical treatment (Table 1). The rate of infection for primary versus secondary cranioplasty showed no statistical significance (P = 1.06).
Discussion Patients older than 14 years were chosen deliberately because the number of complications in pediatric cranioplasty cases, especially those requiring bone reconstruction, is larger than in adult cases.4 In general, in Italy cranioplasty, when available, is the first choice for repositioning a patient’s bone. This prospective study showed a higher rate of complications in patients with autologous cranioplasties. It has to be noted that all bone flaps were sent to a regional bone bank (Istituti Ortopedici Rizzoli) highly qualified for handling and preparing bone. The present findings are consistent with those of other retrospective studies. For example, Matsuno et al2 compared 54 autologous cranioplasties, 58 PMMA cranioplastic prostheses, 7 HA prostheses, 77 titanium cranioplastic prostheses, and 10 cranioplasties accomplished with other materials and found a higher rate of complications (infections) in cranioplasties performed using autologous bone (25.9%). In their comparison of 52 autologous cranioplasties and 32 cranioplasties with PMMA prostheses, Cheng et al3 also showed a higher rate of infection with autologous bone (10.7 vs 6.25% in synthetic cranioplasty). In contrast, De Bonis et al4 conducted a retrospective study that compared 135 autologous cranioplasties with 31 hand-made PMMA, 15 custom-made PMMA, and 20
FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
Q3
Q4
Q5
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224
3
IACCARINO ET AL
225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280
Table 1. EPIDEMIOLOGIC DATA AND INCIDENCE OF COMPLICATIONS IN THE ENTIRE POPULATION (N = 96) COMPARED WITH THE POPULATION STRATIFIED BY MATERIALS USED FOR CRANIOPLASTY
Total Epidemiologic data, n (%) Cases Men/women Age (yr) <40 40-65 >65 Causes for bone removal Trauma Stroke SAH aneurysm Tumor Infection Indication First-line cranioplasty Second-line cranioplasty Site Monolateral Bifrontal Outcome GOSe score #5 GOSe score $6 Timing of cranioplasty (mo) <3 3-6 >6 Complications, n (%) Infections Fractures Bone resorption Other causes of removal Postoperative epidural hematomas Total Requiring surgery Fluid collection Total Requiring surgery
Bone
HA
PMMA
PEEK
96 (100) 68/28
31 (32) 24/7
50 (52) 35/15
13 (14) 8/5
2 (2) 1/1
61 (64) 28 (29) 7 (7)
16 (52) 11 (35) 4 (13)
37 (74) 11 (22) 2 (4)
7 (54) 5 (38) 1 (8)
1 (50) 1 (50) 0 (0)
71 (74) 12 (13) 6 (6) 5 (5) 2 (2)
22 (71) 5 (16) 3 (10) 0 (0) 1 (3)
41 (82) 2 (4) 3 (6) 3 (6) 1 (2)
6 (46) 5 (38) 0 (0) 2 (16) 0 (0)
2 (100) 0 (0) 0 (0) 0 (0) 0 (0)
71 (74) 25 (26)
31 (100) 0 (0)
27 (54) 23 (46)
11 (85) 2 (15)
1 (50) 1 (50)
88 (92) 8 (8)
27 (84) 4 (16)
47 (94) 3 (6)
12 (92) 1 (8)
2 (100) 0 (0)
60 (63) 36 (37)
22 (71%) 9 (29)
30 (60) 20 (40)
8 (62) 5 (38)
1 (50) 1 (50)
5 (5) 31 (32) 60 (63)
3 (10) 18 (58) 10 (32)
0 (0) 9 (18) 41 (82)
2 (15) 4 (31) 7 (54)
0 (0) 0 (0) 2 (100)
4 (4) 1 (1) 2 (2) 0 (0)
3 (10) 0 (0) 2 (6) 0 (0)
1 (2) 1 (2) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0)
18 (19) 3 (3)
10 (32) 2 (6)
7 (14) 1 (2)
1 (8) 0 (0)
0 (0) 0 (0)
7 (7) 1 (1)
4 (13) 1 (3)
3 (6) 0 (0)
0 (0) 0 (0)
0 (0) 0 (0)
Abbreviations: GOSe, Glasgow Outcome Scale extended; HA, hydroxyapatite; PEEK, polyetheretherketone; PMMA, polymethylmethacrylate; SAH aneurysm, subarachnoid hemorrhage owing to rupture of an aneurysm. Iaccarino et al. Methods of Cranial Reconstruction. J Oral Maxillofac Surg 2015.
HA cranioplasties and found no difference in the complication rate among materials. The present study included the largest number of HA cranioplasties (50 with HA, 15 with PMMA and PEEK, and 31 with autologous bone). This distribution could explain the lower global infection rate (4%) compared with the studies cited earlier. HA is usually associated with a lower infection rate, as reported by Stefini et al5 in a series of 1,584 cases. In the present study, there was only 1 case of infection in a patient who underwent cranial reconstruction with an HA
implant after 3 other surgeries owing to infection from a previous prosthesis. No complication was observed in the group reconstructed with the PMMA or PEEK prostheses; however, the number of cases is too small to draw any conclusions. Furthermore, these data show the safety of alloplastic cranioplastic insertion after bone infection. The higher complication rate seen with autologous bone is related to infection and reabsorption.6 These phenomena affected only autologous bone (2 of 31; 6%) and it always required reoperation. The only
FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336
337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354
4
Q6
METHODS OF CRANIAL RECONSTRUCTION
fracture was observed in an HA prosthetic reconstruction (1 of 50; 2%). HA requires osseointegration before gaining sufficient strength. This complication does not necessarily imply the need for a second procedure, because Staffa et al7 described spontaneous bone repair of fractures in 3 cases reconstructed with HA. The present data suggest that cranioplasty with heterologous materials in an adult population produces a lower rate of complications than cranioplasty with an autologous bone flap. Moreover, heterologous devices can be positioned safely even in cases of previous bone failure. This study has been extended to more neurosurgical centers to confirm these preliminary findings.
References 1. Grant GA, Jolley M, Ellenbogen RG, et al: Failure of autologous boneassisted cranioplasty following decompressive craniectomy in children and adolescents. J Neurosurg 100(suppl Pediatrics):163, 2004 2. Matsuno A, Tanaka H, Iwamuro H, et al: Analyses of the factors influencing bone graft infection after delayed cranioplasty. Acta Neurochir (Wien) 148:535, 2006 3. Cheng YK, Weng HH, Ynag JT, et al: Factors affecting graft infection after cranioplasty. J Clin Neurosci 15:1115, 2008 4. De Bonis P, Frassanito P, Mangiola A, et al: Cranial repair: How complicated is filling a hole? J Neurotrauma 29:1071, 2012 5. Stefini R, Esposito G, Zanotti B, et al: Use of ‘ custom made’’ porous hydroxyapatite implants for cranioplasty: Postoperative analysis of complications in 1549 patients. Surg Neurol Int 4:12, 2013 6. Servadei F, Iaccarino C: The therapeutic cranioplasty still needs an ideal material and surgical timing. World Neurosurg 83:133, 2015 7. Staffa G, Barbanera A, Faiola A, et al: Custom made bioceramic implants in complex and large cranial reconstruction: A two-year follow-up. J Craniomaxillofac Surg 40:e65, 2012
FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:29 pm CE AH
355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372
CRANIOMAXILLOFACIAL TRAUMA
Preliminary Results of a Prospective Study on Methods of Cranial Reconstruction Q7 Q2
Corrado Iaccarino, MD,* Edoardo Viaroli, MD,y Marco Fricia, MD,z Elena Serchi, MD,x Tito Poli, Prof,k and Franco Servadei, MD{ Purpose:
Given its biological and anatomic features, autologous bone is the first choice for cranioplasty after bone decompression. When autologous bone is not available or must be replaced, surgeons can choose among various materials to create an alloplastic cranioplasty. The Italian Society for Neurosurgery promoted a prospective study conducted at 4 Italian neurosurgical units to compare different methods of cranioplasty and to assess the clinical results and incidence of complications.
Materials and Methods:
Patients older than 14 years who underwent repositioning of autologous bone or 3-dimensional image-guided reconstruction with prostheses made of an alloplastic material (polyetheretherketone, polymethylmethacrylate, or hydroxyapatite) after cranial decompression were enrolled prospectively from January 2008 through December 2013. The collected data included the material used to produce the prosthesis, the type of cranioplasty (primary or secondary), and complications that required surgical removal of the prosthesis (eg, infection, bone resorption, and fracture of the cranioplasty).
Results:
Ninety-six patients met the study criteria. Fifty cases were reconstructed with hydroxyapatite, 31 with bone, 13 with polymethylmethacrylate, and 2 with polyetheretherketone. Seven patients (7.3%) developed complications related to the cranioplastic implant that required reoperation. These complications included infection (4 cases), bone resorption (2 cases), and fracture of the cranioplastic prosthesis (1 case). Statistical analysis showed a higher rate of complications with the use of autologous bone versus alloplastic materials (P = .03). Owing to the limited number of cases, no statistically meaningful complication was seen among the different alloplastic materials or when the cranioplastic implant was placed as secondary treatment.
Conclusions: These data and those of other reports suggest that cranioplasty conducted using alloplastic 3-dimensional reconstruction materials have a lower rate of complications than those conducted using autologous bone. Ó 2015 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg -:1-4, 2015
There is an increasing need for reconstruction after cranial decompression from various pathologies. Cranial reconstructive surgery often involves maxillofacial surgeons, neurosurgeons, and plastic surgeons.
The gold standard for cranial reconstruction remains to be determined, and, overall, cranioplasties produce a high rate of complications. To date, many retrospective studies have compared different
*Staff Neurosurgeon, Neurosurgery-Neurotraumatology Unit,
Drs Iaccarino and Servadei received limited grants for educational
AOU Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy.
purposes from Codman Co. Dr Viaroli had a consultant role for
yStaff Neurosurgeon, Neurosurgery-Neurotraumatology Unit,
16 months at Finceramica.
AOU Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy. zStaff Neurosurgeon, Neurosurgery Unit, ‘ Cannizzaro’’ Hospital,
Address correspondence and reprint requests to Dr Iaccarino: Neurosurgery-Neurotraumatology Unit, University Hospital of
Catania, Italy.
Parma, Emergency Neurosurgery Unit, IRCCS ‘ASMN’’ of Reggio Emi-
xStaff Neurosurgeon, Neurosurgery Unit, IRCCS Neuroscience
lia, Viale Risorgimento, 80-42100 Reggio Emilia, Italy; e-mail:
Institute, Bologna, Italy.
[email protected]
kAssociate Professor, Maxillofacial Surgery Unit, AOU Parma,
Received May 15 2015
Parma, Italy.
Accepted July 10 2015
{Department Head, Neurosurgery-Neurotraumatology Unit, AOU
Ó 2015 American Association of Oral and Maxillofacial Surgeons
Parma, ASMN-IRCCS Reggio Emilia, Reggio Emilia, Italy.
0278-2391/15/01007-1 http://dx.doi.org/10.1016/j.joms.2015.07.008
1 FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112
113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168
2
METHODS OF CRANIAL RECONSTRUCTION
materials used for cranioplasty to determine the main factors involved in the development of postoperative complications.1-3 To the authors’ knowledge, this study is the first prospective work with the same objective.
Materials and Methods DATA COLLECTION
Data from neurosurgical registries at 4 different hospitals in Italy (University Hospital of Parma, ASMN Reggio Emilia, Bellaria Hospital of Bologna, and Cannizzaro Hospital of Catania) were collected prospectively from 2008 through 2013. The study was approved by the local institutional review board and ethical committee of the principal investigator’s center at the start of the study. Patients eligible for the study underwent cranioplasties performed with 4 different materials: autologous bone that the patient donated from the previous surgery for decompressive craniectomy or bone removal that had been stored in an institutional bone bank (Istituti Ortopedici Rizzoli, Bologna, Italy), custom-made hydroxyapatite (HA), custom-made polymethylmethacrylate (PMMA), or custom-made polyetheretherketone (PEEK). The data collected included patient age, reason for bone removal (trauma, subarachnoid hemorrhage owing to rupture of an aneurysm, stroke, tumor, infection), material used to create the cranioplastic prosthesis, type of cranioplasty (primary or secondary), complications that required surgical reoperation, clinical follow-up data (evaluated with the extended Glasgow Outcome Scale), and radiologic follow-up data ($6 months; 11 7 months; Table 1). Patients younger than 14 years were excluded. The 4 centers involved prospectively shared the same database and the same clinical and radiologic follow-up data but did not specifically randomize patients to a specific treatment. STATISTICAL ANALYSIS
The patient population was divided into 2 groups, autologous bone or alloplastic prosthesis, which were compared using an odds ratio based on the need for a second operation. The same analysis was performed by comparing porous HA devices with synthetic material (PEEK and PMMA) used for cranioplasty and by comparing primary with secondary cranioplasty (performed after a complication).
Results Ninety-six patients met the study criteria: 31 underwent a cranioplasty with autologous bone, 50 with HA, and 15 with synthetic materials (13 with PMMA and 2 with PEEK). All alloplastic cranioplasties were
Q1
custom made using 3-dimensional computed tomographic reconstruction techniques. Clinical and radiological data are presented in Table 1. Among patients in the alloplastic cranioplasty group, 39 underwent placement of a primary cranioplasty (27 with HA and 12 with PMMA or PEEK) and 26 (23 with HA and 3 with PMMA or PEEK) underwent a secondary cranioplasty because of bone resorption (21 cases) or infection of a previous cranioplasty (5 cases). Seven patients developed complications related to the cranioplasty and required a second operation: 4 developed infections (3 in the autologous bone group and 1 in the HA group), 1 had a postoperative fracture of an HA prosthesis, and 2 had bone resorption. Custom-made PEEK and PMMA devices were not associated with any complications. The odds ratio showed a relation between the use of autologous bone and the development of major complications (P = .03710) compared with alloplastic materials. No meaningful difference was found for the comparison between different alloplastic materials or between primary and secondary cranioplasty. Furthermore, no meaningful difference was seen in the rate of hematomas after cranioplasty requiring surgical treatment (Table 1). The rate of infection for primary versus secondary cranioplasty showed no statistical significance (P = 1.06).
Discussion Patients older than 14 years were chosen deliberately because the number of complications in pediatric cranioplasty cases, especially those requiring bone reconstruction, is larger than in adult cases.4 In general, in Italy cranioplasty, when available, is the first choice for repositioning a patient’s bone. This prospective study showed a higher rate of complications in patients with autologous cranioplasties. It has to be noted that all bone flaps were sent to a regional bone bank (Istituti Ortopedici Rizzoli) highly qualified for handling and preparing bone. The present findings are consistent with those of other retrospective studies. For example, Matsuno et al2 compared 54 autologous cranioplasties, 58 PMMA cranioplastic prostheses, 7 HA prostheses, 77 titanium cranioplastic prostheses, and 10 cranioplasties accomplished with other materials and found a higher rate of complications (infections) in cranioplasties performed using autologous bone (25.9%). In their comparison of 52 autologous cranioplasties and 32 cranioplasties with PMMA prostheses, Cheng et al3 also showed a higher rate of infection with autologous bone (10.7 vs 6.25% in synthetic cranioplasty). In contrast, De Bonis et al4 conducted a retrospective study that compared 135 autologous cranioplasties with 31 hand-made PMMA, 15 custom-made PMMA, and 20
FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
Q3
Q4
Q5
169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224
3
IACCARINO ET AL
225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280
Table 1. EPIDEMIOLOGIC DATA AND INCIDENCE OF COMPLICATIONS IN THE ENTIRE POPULATION (N = 96) COMPARED WITH THE POPULATION STRATIFIED BY MATERIALS USED FOR CRANIOPLASTY
Total Epidemiologic data, n (%) Cases Men/women Age (yr) <40 40-65 >65 Causes for bone removal Trauma Stroke SAH aneurysm Tumor Infection Indication First-line cranioplasty Second-line cranioplasty Site Monolateral Bifrontal Outcome GOSe score #5 GOSe score $6 Timing of cranioplasty (mo) <3 3-6 >6 Complications, n (%) Infections Fractures Bone resorption Other causes of removal Postoperative epidural hematomas Total Requiring surgery Fluid collection Total Requiring surgery
Bone
HA
PMMA
PEEK
96 (100) 68/28
31 (32) 24/7
50 (52) 35/15
13 (14) 8/5
2 (2) 1/1
61 (64) 28 (29) 7 (7)
16 (52) 11 (35) 4 (13)
37 (74) 11 (22) 2 (4)
7 (54) 5 (38) 1 (8)
1 (50) 1 (50) 0 (0)
71 (74) 12 (13) 6 (6) 5 (5) 2 (2)
22 (71) 5 (16) 3 (10) 0 (0) 1 (3)
41 (82) 2 (4) 3 (6) 3 (6) 1 (2)
6 (46) 5 (38) 0 (0) 2 (16) 0 (0)
2 (100) 0 (0) 0 (0) 0 (0) 0 (0)
71 (74) 25 (26)
31 (100) 0 (0)
27 (54) 23 (46)
11 (85) 2 (15)
1 (50) 1 (50)
88 (92) 8 (8)
27 (84) 4 (16)
47 (94) 3 (6)
12 (92) 1 (8)
2 (100) 0 (0)
60 (63) 36 (37)
22 (71%) 9 (29)
30 (60) 20 (40)
8 (62) 5 (38)
1 (50) 1 (50)
5 (5) 31 (32) 60 (63)
3 (10) 18 (58) 10 (32)
0 (0) 9 (18) 41 (82)
2 (15) 4 (31) 7 (54)
0 (0) 0 (0) 2 (100)
4 (4) 1 (1) 2 (2) 0 (0)
3 (10) 0 (0) 2 (6) 0 (0)
1 (2) 1 (2) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0)
0 (0) 0 (0) 0 (0) 0 (0)
18 (19) 3 (3)
10 (32) 2 (6)
7 (14) 1 (2)
1 (8) 0 (0)
0 (0) 0 (0)
7 (7) 1 (1)
4 (13) 1 (3)
3 (6) 0 (0)
0 (0) 0 (0)
0 (0) 0 (0)
Abbreviations: GOSe, Glasgow Outcome Scale extended; HA, hydroxyapatite; PEEK, polyetheretherketone; PMMA, polymethylmethacrylate; SAH aneurysm, subarachnoid hemorrhage owing to rupture of an aneurysm. Iaccarino et al. Methods of Cranial Reconstruction. J Oral Maxillofac Surg 2015.
HA cranioplasties and found no difference in the complication rate among materials. The present study included the largest number of HA cranioplasties (50 with HA, 15 with PMMA and PEEK, and 31 with autologous bone). This distribution could explain the lower global infection rate (4%) compared with the studies cited earlier. HA is usually associated with a lower infection rate, as reported by Stefini et al5 in a series of 1,584 cases. In the present study, there was only 1 case of infection in a patient who underwent cranial reconstruction with an HA
implant after 3 other surgeries owing to infection from a previous prosthesis. No complication was observed in the group reconstructed with the PMMA or PEEK prostheses; however, the number of cases is too small to draw any conclusions. Furthermore, these data show the safety of alloplastic cranioplastic insertion after bone infection. The higher complication rate seen with autologous bone is related to infection and reabsorption.6 These phenomena affected only autologous bone (2 of 31; 6%) and it always required reoperation. The only
FLA 5.4.0 DTD YJOMS56913_proof 3 August 2015 12:28 pm CE AH
281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336
337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354
4
Q6
METHODS OF CRANIAL RECONSTRUCTION
fracture was observed in an HA prosthetic reconstruction (1 of 50; 2%). HA requires osseointegration before gaining sufficient strength. This complication does not necessarily imply the need for a second procedure, because Staffa et al7 described spontaneous bone repair of fractures in 3 cases reconstructed with HA. The present data suggest that cranioplasty with heterologous materials in an adult population produces a lower rate of complications than cranioplasty with an autologous bone flap. Moreover, heterologous devices can be positioned safely even in cases of previous bone failure. This study has been extended to more neurosurgical centers to confirm these preliminary findings.
References 1. Grant GA, Jolley M, Ellenbogen RG, et al: Failure of autologous boneassisted cranioplasty following decompressive craniectomy in children and adolescents. J Neurosurg 100(suppl Pediatrics):163, 2004 2. Matsuno A, Tanaka H, Iwamuro H, et al: Analyses of the factors influencing bone graft infection after delayed cranioplasty. Acta Neurochir (Wien) 148:535, 2006 3. Cheng YK, Weng HH, Ynag JT, et al: Factors affecting graft infection after cranioplasty. J Clin Neurosci 15:1115, 2008 4. De Bonis P, Frassanito P, Mangiola A, et al: Cranial repair: How complicated is filling a hole? J Neurotrauma 29:1071, 2012 5. Stefini R, Esposito G, Zanotti B, et al: Use of ‘ custom made’’ porous hydroxyapatite implants for cranioplasty: Postoperative analysis of complications in 1549 patients. Surg Neurol Int 4:12, 2013 6. Servadei F, Iaccarino C: The therapeutic cranioplasty still needs an ideal material and surgical timing. World Neurosurg 83:133, 2015 7. Staffa G, Barbanera A, Faiola A, et al: Custom made bioceramic implants in complex and large cranial reconstruction: A two-year follow-up. J Craniomaxillofac Surg 40:e65, 2012
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