Trauma; oral surgery

The use of fresh frozen allogeneic bone for maxillary and mandibular reconstruction

David H. Perrott, 1 Richard A. Smith, 2 L e o n a r d B. K a b a n , 3 1Assistant Professor, Department of Oral and Maxillofacial Surgery, University of California, San Francisco, 2Clinical Professor, Department of Oral and Maxillofacial Surgery, University of California, San Francisco, 3Professor and Chairman, Department of Oral and Maxillofacia[ Surgery, University of California, San Francisco

David H. Perrott, Richard A. Smith, Leonard B. Kaban." The use of Jkesh frozen allogeneic bone for maxillary and mandibular reconstruction. Int. J. Oral Maxillofac. Surg. 1992," 21." 260-265. Abstract. The use of fresh frozen bone (FFB) alone, or in combination with autogenous bone (AB), for bony augmentation of the maxilla and mandible in preparation for dental reconstruction with endosseous implants has been studied. Ten patients received FFB __AB for augmentation of a severely atrophic mandible (n = 6) or for reconstruction of a jaw defect secondary to trauma or tumor resection (n = 4). Average follow-up was 26,3 +_5.4 months. At the time of implant placement, the bone grafts were found to be firm in consistency, well incorporated, and well vascularized in all 10 patients. Twenty-nine endosseous implants were placed an average of 8.3 _+3.1 months following bone grafting. One implant failed and was replaced, and one implant remains buried as a nonfunctional unit. All patients have been restored prosthetically by means of 28 of the 29 implants. This preliminary study indicates that F F B may be used alone or in combination with autogenous bone for augmentation or reconstruction of the atrophic maxilla and mandible. The resultant ridge is adequate to support loaded endosseous implants. A potential disadvantage is the minimal risk of disease transmission.

Introduction

Reconstruction of the severely atrophic maxilla and mandible or defects secondary to tumor resection or trauma remains a major challenge for oral and maxillofacial surgeons. The goals of reconstructive procedures are anatomically to restore skeletal and soft tissue anatomy and to provide the patient with an aesthetically acceptable and functional prosthesis. BOYNE5 suggested that the ideal reconstructive material to replace bone should: 1) facilitate revascularization, osteogenesis, and osteoinduction; 2) not exhibit antigenic properties; 3) exist in unlimited supply without the need of a donor site; and 4) provide adequate stability and support. Soon the surgeon will be able to choose alloplastic materials or autogenous or allogeneic bone to reconstruct the maxilla and mandible 2'3,5m 13,16,18,20,21,23~7,3133. The most common allogeneic bone preparation currently in use is freezedried banked bone. It is readily available in large quantities but revascularization takes longer than in the case

of autogenous bone, and the graft heals by resorption and osteoconduction. In addition, freeze-dried allografts have no osteoinductive potential 28. Demineralized bone preparations, e.g. autolyzed antigen-extracted allogeneic bone, have been used with mixed results in human beings 34. These bone implants heal by the process of osteoinduction. The variable outcome in clinical usage is thought to be secondary to inadequate preservation of osteoinductive proteins during the demineralization and sterilization process. An alternative allograft is fresh frozen bone (FFB) m3°. It is harvested aseptically from live (e.g. patients undergoing total hip replacement) or cadaver donors and then frozen. There is no additional preparation and the osteoinductive proteins are preserved. There is limited information about the use of this material in maxillofacial procedures. This is a preliminary study to evaluate the use of FFB, with and without autogenous bone (AB), to reconstruct maxillary and mandibular defects.

Key words: reconstructive preprosthetic surgery; augmentation; fresh frozen bone; endesseous implants; bone grafts. Accepted for publication 30 April 1992

Material and methods

Ten patients underwent bone grafting procedures and subsequent placement of endosseous implants. There were nine females and one male in the group and the average age was 47.79 +_ 16.73 years. Six patients had severe mandibular atrophy (CAwOOD & HOWELL; Type VI) l°, and four patients had jaw defects secondary to either tumor resection or trauma (Table 1). The six patients with mandibular atrophy were augmented with a combination of F F B and AB. In five of the six patients, rib was the AB; iliac bone was used in the remaining patient. The operative technique to augment the upper mandibular border was described by DAVIS et al. 12 and BAKER et al. 3. First, two autogenous ribs were harvested. The ribs were of sufficient length to allow construction of a full thickness lingual strut and to provide additional AB corticocancellous chips. The autogenous rib was secured along the lingual aspect of the mandible with either wire or resorbable sutures. Next,

Jaw reconstruction with F F B

a mixture of milled F F B and corticocancellous AB (rib) was packed lateral to the strut, thereby increasing the width and height of the mandible (Fig. 1). Lower border grafting was completed in two patients by the technique described by POGREL3°. A rib of adequate length was harvested from the thorax. This rib was split and secured along the inferior border of the mandible, creating dead space. A milled mixture of fresh frozen bone and cortico-cancellous AB (rib) was packed in the dead space (Fig.

2). In the four patients with jaw defects, the graft was placed in a dissected subperiosteal pocket. In two patients, a milled mixture of F F B and AB bone (iliac crest) was placed. In the remaining two patients, only milled F F B was placed. Three patients underwent a vestibuloplasty with split-thickness skin graft an average of 3.25 _+0.25 months following the bone grafting procedure. Titanium endosseous implants were placed an average of 8.3 + 3.4 months following bone grafts. A total of 29 implants were placed without operative complications

(Table 1). Implants were allowed to integrate an average of 7.4 + 3.7 months before the patients underwent prosthetic restoration. Results

Average follow-up of the l0 patients in this study was 26.3___5.4 months. A total of 29 implants were placed: one failed and was subsequently successfully replaced, and one remains buried as a nonfunctional unit. At the time of implant placement, the bone was firm, well incorporated, and vascularized in all but one case (Fig. 3). In this patient, there was one small area of soft bone that would not have supported an endosseous implant. Therefore the implants were placed proximal and distal to the area without complications. Implants were considered integrated by direct clinical examination and radiographic signs of a good implant/bone interface. In three patients who were reconstructed with F F B and AB, there was a serous fluid accumulation and wound dehiscence. Cultures were negative. One patient required hospitalization for

Fig. 1. Sixty-four-year-old female with severe mandibular atrophy (patient JH, Table 1). (A) Preoperative panoramic radiograph. Note severe atrophy of mandible with inferior alveolar nerve canal dehisced. (B) Immediate postoperative panoramic radiograph following superior border mandibular augmentation with FFB+AB and lingual rib strut.

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drainage and wound care. Once the fluid was drained, the wound dehiscence gradually healed by granulation and contraction. Seven patients experienced minor exfoliation of bone chips. There were no long-term complications, and the final treatment outcome was not compromised by any of these early problems. All 10 patients have been treated prosthetically with 28 implants. Two patients were rehabilitated with fixed/removable, and eight patients with mucosa-supported, prostheses (Figs. 4 and 5). Patients have been functioning on their prosthesis and loaded implants for an average of 7.9_+ 4.2 months. During follow-up radiographic examinations, there has been no sign of peri-implant bone loss (Figs. 4 and 5). Discussion

Autogenous bone has been widely used for reconstructive procedures in the maxilla and mandible2,3,5,11,18,21,24-27,29,31,32. The advantages of AB include: 1) lack of immunologic rejection potential and 2) rapid revascularization. Disadvantages include: 1) donor site morbidity, 2) potentially inadequate quantity for large defects, and 3) unpredictable resorption 19. Allogeneic grafts offer an alternative to autogenous bone. The use of freezedried bone for reconstructive maxillofacial procedures has been reported 2°'27. Its advantages include: 1) little or no immunologic response and 2) unlimited quantities 17. A potential disadvantage of its use is the very minimal risk of disease transmission. Although the preparation technique decreases antigenicity and the risk of disease transmission, it also decreases the osteogenic potential of the bone 28,3°.The decrease in osteogenic potential and the relative lack of structural integrity are disadvantages in major reconstructive procedures when no autogenous bone is used. F F B offers an alternative to freezedried, demineralized, and autogenous bone. It can be obtained from the bone bank as cortico-cancellous blocks, cortico-cancellous chips, or pure cancellous bone. F F B cortico-cancellous blocks are structurally stronger than freezedried bone 3~. At the time of placement, F F B has characteristics (e.g. texture, strength) similar to those of autogenous bone. The most important advantage of F F B is that osteoinductive proteins are not destroyed in the preparation 3°. We

262

P e r r o t t et aL

Fig. 2. Fifty-four-year-old female with fractured, severely atrophic mandible (patient LS, Table 1). (A) Panoramic radiograph demonstrates placement of inferior border bone plate for fracture treatment. (B). Immediate postoperative panoramic radiograph demonstrates inferior border bone graft with autogenous rib and FFB.

hypothesize that maintenance of osteoinductive proteins in F F B preparations will result in better bone formation and better long-term bone graft maintenance. The complications we experienced in a few patients were serous fluid accumu-

lation, wound dehiscence, and exfoliation of bone chips. The fluid may have been related to the short time we allowed the F F B to thaw before use. After increasing thawing time to 2 hours, only one additional patient developed fluid accumulation. A l t h o u g h

additional defrosting appeared to decrease the a m o u n t of fluid accumulation, it is possible that this phenomenon may be related to an immunologic response to the graft. Fresh frozen bone does have antigenic characteristics which may persist for several months TM. The m a r r o w is the most immunogenic element o f bone while the graft is slowly resorbed by the host s,= . Therefore, exposure of m a r r o w (donor antigen) to host i m m u n o c o m petent cells occurs over an extended period of time. It is hypothesized that this long exposure allows for a balance to be established between the release of antigen and antibody formation. This immunologic response is very weak since h u m a n beings grafted with F F B have demonstrated no detectable serum antibodies 4'22. The fluid accumulation noted in our patients usually occurred within the first m o n t h following grafting. This clinical finding may represent a localized immunologic reaction. All wound dehiscence occurred in the areas of fluid accumulation. Once the fluid was drained, the wounds slowly granulated closed with no significant effect on the clinical outcome. It should be noted that w o u n d dehiscence has also been reported following the use o f freeze-dried and autogenous bone 2v. The exfoliation of small bone chips was noted early in the study. Initially, patients were not allowed to use a transitional prosthesis during the first 3 months postoperatively. The particulate matter graft was not compressed and may have been traumatized. Later in the study, we allowed patients to use a transitional prosthesis, beginning 8

Table 1.

Patient GB JH PC LS LA CP LM LW RH CR

Defect Mandibular atrophy Mandibular atrophy Mandibular atrophy Mandibular atrophy Mandibular atrophy Mandibular atrophy ~'2 Myxoma Ameloblastoma ~ Maxillary defect 2° to trauma 1 Anterior maxillary defect 2 ° to bone necrosis 1

Type of allograft

Implant type

Location of implant placement

Rib and FFB Rib and FFB Rib and FFB Rib and FFB Iliac bone and FFB Rib and FFB FFB FFB

Screw-vent ®* Screw-vent ®* Screw-vent ®* Screw-vent ®* Brgmemark ®~ Brgmemark ®§ Bffmemark®~ Br~nemark ®~

Anterior Anterior Anterior Anterior Anterior Anterior Anterior Anterior

Rib and FFB

Microvent®*

Iliac bone and FFB

Br~memark ®~

1 Patient underwent vestibuloplasty. 2 One implant failed and was replaced before prosthetic restoration. * Core-Vent Corporation, Encino, CA. Nobelpharma Corporation, Waltham, MA.

Number placed

Implants loaded

2 2 2 2 2 4 4 2

2 2 2 2 2 4 4 2

Maxilla

6

5

Maxilla

3

3

mandible mandible mandible mandible mandible mandible mandible mandible

J a w reconstruction with F F B

Fig. 3. Intraoperative photograph of the mandible at the time of implant placement and 6 months following grafting procedure. (A = autogenous rib lingual strut; B = area of FFB + AB bone graft.)

Fig. 4. Follow-up of patient in Figure 1. (A) Ten-month follow-up panoramic radiograph taken at the time of implant abutment placement. (B) Twenty-four-month follow-up panoramic radiograph. Patient has been functioning with an overdenture for 1 year. Note the consolidation of bone graft on upper border and presence of inferior alveolar canal and mental foramen surrounded by bone.

263

weeks postoperatively. This allowed compression of the graft into the final ridge form more quickly and protected it from traumatic injury. Most importantly, the clinical complications described had little or no effect on final ridge form. There was little bone loss in the area of fluid accumulation, and the amount of bone exfoliated was minimal. However, these complications did delay the placement of implants. The major disadvantage of F F B is the small risk of disease transmission. F F B is procured from appropriate cadaver or live donors by sterile collection techniques and then stored at - 70°C. At the University of California, San Francisco (UCSF), every potential donor undergoes a thorough medical historY screening (Table 2). Cadaver donors undergo autopsy and a series of serologic tests (Table 3). Living donors, e.g. patients undergoing total joint replacement, read and sign a consent form which outlines the major risk groups for HIV (human immunodeficiency virus) transmission and allows the bone bank to obtain followup serology tests (Table 4). Since the bone is kept in quarantine until additional HIV testing is completed, the risk of transmission is very small. Before either cadaver or living donor bone release, the history, physical examination, hospital course, autopsy when applicable, and laboratory studies are reviewed for negative results. Only after meeting these criteria is F F B released from the bone bank for transplantation. It is estimated that the risk of HIV transmission is less than 1:1 000 000 in cadaver donors 9. This risk is probably even lower in living donors because the 180-d repeat HIV antibody test is completed before release of the bone. By the use of these protocols, the risk of HIV transmission is less than that of nonautogenous blood transfusions 7. However, this risk of F F B must be carefully explained to the patient and alternatives must be presented. Finally, the success of endosseous implants placed in bone grafts has been estimated to range from 73.8 to 95.0%, depending upon the area grafted 2'6'18'24,26. Thus far, our success rate of 96.5% is comparable to that of nongrafted areas 1. However, the long-term success rate is yet to be determined. The results of this preliminary study indicate that F F B is potentially an ex-

264

Perrott et aL Table 3. * Cadaver donor laborjato~y studies

HIV Antigen HIV Antibody HTLV- 1 Antibody HBsAg HBsAb HCV CMV RPR ABO/RhO ALT 14-d aerobic and anaerobic tissue cultures 14-d blood cultures * Key to abbreviations: HIV = human immunodeficiency virus; HTLV-1 = human Tcell lymphocytotrophic virus I; HBsAg = hepatitis B surface antigen; HBsAb = hepatitis B surface antibody; HCV = Type C, hepatitis virus; RPR = rapid plasma reagin; CMV = cytomegalovirus; ABO/RhO = ABO blood groups/Rh blood groups; ALT = alanine aminotransferase.

Table 4. Living donor laboratory studies

Fig. 5. Follow-up of patient in Figure 2. (A) Five-month follow-up panoramic radiograph

taken at time of implant placement. (B) Sixteen-month follow-up panoramic radiograph. Patient has been functioning with an overdenture for 6 months.

HIV Antibody 180-d HIV antibody HTLV- 1 antibody 180-d HTLV-1 antibody HBsAg HBsAb HCV RPR ALT 14-d aerobic and anaerobic tissue cultures For abbreviations, see Table 3.

cellent graft m a t e r i a l for the t r e a t m e n t of maxillary a n d m a n d i b u l a r defects. It appears that small defects m a y be successfully r e c o n s t r u c t e d by using only F F B . By using b o n e with osteoinductive proteins and placing i m p l a n t s to distribute forces, we h o p e t h a t the grafted b o n e will d e m o n s t r a t e little l o n g - t e r m resorption. However, l o n g - t e r m m a i n -

t e n a n c e o f ridge height a n d i m p l a n t success need to be studied. References A c k n o w l e d g m e n t . This study was fun-

ded by the University o f California, San Francisco, D e p a r t m e n t of Oral a n d Maxillofacial Surgery R e s e a r c h F u n d .

Table 2. * UCSF tissue bank donor information screening checklist

History

Current

AIDS/ARC Homosexuality Intravenous drug use Connective tissue disease Autoimmune disease Insulin dependent diabetes Slow virus (e.g. Creutzfeldt-Jakob disease) Malignancy Hepatitis Syphilis Exposure to toxic chemicals Recent transfusions Immunization within 4 weeks Irradiation Human pituitary-derived growth hormone

Active infection Local Systemic Viral Fungal Neurologic disease Alzheimer's Dementia Sclerosis Disease of unknown etiology Unexplained jaundice Substance abuse

* Key to abbreviations: AIDS = acquired immune deficiency syndrome; ARC = AIDS-related complex.

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Address: David H. Perrott, UCSF Department of Oral and Maxillofacial Surgery 521 Parnassus Avenue Box 0440 San Francisco, CA 94143-0440 USA