Effects of grafting on porous metal ingrowth: A canine model

Twenty-five mongrel dogs were studied using implantation of autograft, fresh-frozen allograft, and beta-tricalcium phosphate around a porous-coated chrome-cobalt plug in the distal femoral metaphysis; interference-fit and overreamed control specimens were also studied. Over the course of this 4-month study, bone ingrowth through the grouting materials into the center plug was noted for autologous, allograft, and ceramic specimens. Quantitatively, in terms of push-out strength and histology, there were no significant differences between grafted groups; significantly higher push-out strengths were attained in each grafted subgroup compared with nongrafted, overreamed control subjects. In the setting of uncemented revision total hip arthroplasty, bone-grafting is frequently required. Because of the limited availability of autogenous bone and the potential liabilities of allograft material, attention has been given to bone substitutes. On the basis of this preliminary study, bone ingrowth into a porous metal substrate has been documented to occur through autograft, allograft, or ceramic grouting agents. Within the limits of this nonloaded experimental model, it appears that these materials are comparable in terms of their osteoconductive capability. Even in the optimal laboratory situation, bone ingrowth does not appear to occur in a canine model across a nongrafted 2-mm gap with regularity over a 16-week period.     

Porous-coated femoral components in a canine model for revision arthroplasty

Six dogs had a total hip arthroplasty during which the femoral component was coated with methacrylate and inserted in the femoral canal, after the canal had been reamed to a larger diameter than that of the femoral stem (including the coating). Thus, the implant was loose and motion was present between it and the femur in each animal. Five dogs had a revision to a prosthesis with a porous polysulfone-coated stem. This prosthesis was not cemented in place. One dog was killed before the revision for the purpose of histological examination. Although bone was present in the porous surface of all five stems at the revision, the amount was scant in three. CLINICAL RELEVANCE: A model is described for the study of cemented hip-replacement prostheses that have failed. Although variable amounts of ingrowth of bone were observed after the revision to the porous-coated prostheses without bone cement, further study is needed to determine whether adequate ingrowth of bone occurs in this model.     

Mechanical characteristics of the bone-graft-cement interface after impaction allografting.

Impaction allografting is an attractive procedure for the treatment of failed total hip replacements. The graft-cement-host bone interface after impaction allografting has not been characterized, although it is a potential site of subsidence for this type of revision total hip reconstruction. In six human cadaveric femurs, the cancellous bone was removed proximally and local diaphyseal lytic defects were simulated. After the impaction grafting procedure, the specimens were sectioned in 6 mm transverse sections and push-out tests were performed. From the adjacent sections the percentage cement contact of the PMMA cement with the endosteal bone surface was determined. The host bone interface mechanical properties varied significantly along the femur largely due to different interface morphologies. The apparent host bone interface shear strength was highest around the lesser trochanter and lowest around the tip of the stem. A significant positive correlation was found between the percentage cement contact and the apparent host bone interface shear strength (r2 = 0.52). The sections failed in 69% of the cases through a pure host bone interface failure without cement or allograft failure, 19% failed with local cement failure, and 12% with a local allograft failure. The apparent host bone interface strength was on average 89% lower than values reported for primary total hip replacements and were similar to cemented revisions proximally and lower distally. This study showed that cement penetration to the endosteal surface enhanced the host bone-graft interface.     

The use of a hydroxyapatite-coated primary stem in revision total hip arthroplasty

Proximal ingrowth of femoral components in total hip arthroplasty (THA) is desirable because it minimizes proximal stress shielding associated with distal ingrowth stems and maximizes bone stock. This is a retrospective evaluation of initial results of revision THA using a proximally hydroxyapatite-coated femoral stem nominally designed for primary use. Patients requiring femoral stem revision were included if they had sufficient femoral bone stock to support a proximally fixed prosthesis (n = 33). This represents 53% of the femoral revisions performed during the period of the study. The average follow-up was 5 years (range 48-88 months). The mean Harris hip and Oxford hip scores were 86.5 and 25.2, respectively. Radiographically, 100% of the stems demonstrated bone ingrowth fixation. These results are superior to previous reports of primary cementless stems for revision THA. The use of a cementless nonmodular implant provides a viable option in some patients undergoing revision THA.     

Osteoinductive agents in reconstructive hip surgery: a look forward

The use of autograft and allograft material to restore bone stock and promote healing and implant stabilization is a crucial part of total hip arthroplasty, especially in the revision situation. Recent research has centered on the use of osteoinductive materials such as osteogenic proteins or bone morphogenetic proteins to promote bone formation. These proteins are members of the transforming growth factor-beta superfamily of proteins that either alone or in combination with other regulatory molecules induce new bone formation. The cloning and genetic expression of recombinant human bone proteins has led to production of quantities sufficient for their clinical development. Preclinical studies have shown that the osteoinductive capacity of autograft and allograft bone can be improved with the addition of osteogenic proteins. Although these proteins are effective alone, their use with cancellous and cortical allograft and autograft consistently improved the amount and rate of new bone formation compared with graft alone resulting in earlier graft incorporation and consolidation. When placed in defects adjacent to porous acetabular components, the use of an osteogenic protein resulted in earlier defect healing and improved component fixation by the enhancement of bone ongrowth and ingrowth. Although no detailed clinical studies have been reported to date, an anecdotal report of their use with and without bone graft indicate results consistent with those obtained in preclinical studies.     

Restoration of bone defect and enhancement of bone ingrowth using partially demineralized bone matrix and marrow stromal cells

PURPOSE: This study aimed to investigate the capability of combining marrow stromal cells (MSC) and partially demineralized bone matrix (PDBM) to fill bone defect and enhance bone ingrowth using a canine non-weight-bearing gap model. METHODS: Custom-made implants with 3mm gap between the porous surface and the host bone were used. The implants were inserted into the distal femurs of 25 mongrel dogs and the gaps were randomly assigned to be filled with culture-expanded autologous MSC-loaded PDBM, autograft, fresh-frozen allograft, PDBM alone, or nothing as controls. Histomorphometry using backscattered scanning electron microscopic examination, and mechanical push-out test were performed at 6 months after surgery. RESULTS: Histomorphometry showed that amounts of bone regeneration in the gap and bone ingrowth into the porous-coated surface in the MSC-loaded PDBM-treated group were comparable to those of autograft-treated group and were significantly greater than those of allograft-treated, PDBM-treated, or non-grafted groups. Mechanical test showed the same differences. CONCLUSION: The results of this study showed that combining PDBM and autologous culture-expanded MSC restored bone stock and enhanced bone ingrowth into the porous-coated area in a canine non-weight-bearing gap model. This combination may provide an option for reconstructing bone defect when we perform a cementless revision arthroplasty.     

Revision of total hip arthroplasty using an anterior cortical window, extensive strut allografts, and an impaction graft: follow-up study

PURPOSE: To report the outcome of revised total hip arthroplasty procedures involving an anterior cortical window, extensive strut allografts, and an Exeter impaction graft. METHOD: Eight patients (9 hips) with a mean age of 58 years underwent revision of total hip arthroplasty using the Exeter hip impaction graft system and strut allografts between 1995 and 1998. An extensile anterior approach was used, and an anterior cortical window was created in the femur, to remove the old implant. External strut allografts were attached by wires to provide cortical support. The mean follow-up duration was 74 months. Indications for surgery were aseptic loosening of previous implants in 8 hips and infection of one hip that had previously undergone total arthroplasty. RESULTS: 19 Dall Miles cables, 4 ordinary cerclage wires, and 8 cerclage wires tightened with the clincher knot technique were used to secure the allograft to the host bone. The strut grafts were found to be incorporated in all cases. No wires became loose. One patient developed 20 degrees of angulation at the allograft-host bone junction. Using the method of Fowler and Gie, we found that one femoral implant had subsided 2 mm within the cement mantle. Two other implants had 1 mm of subsidence at the cement bone interface, and one patient had a major subsidence of 15 mm that required revision. CONCLUSION: Using an anterior cortical window in the femur to remove the old implant does not predispose to failure of the allograft to incorporate into the host bone.     

Acetabular preparation in cementless revision total hip arthroplasty

The rationale for and experience with the use of a hemispherical, cementless, microporous socket (Harris-Galante prosthesis) are presented as an approach to acetabular revision arthroplasty. Advantages are noted in preservation of existing bone, ease of rigid fixation, and bone grafting with either lyophylized particle allograft or autograft. The early results of a series of 75 sockets show no loss of fixation, mild to major resorption of non-contained bone graft, and favorable roentgenographic appearance of contained bone graft. In bone-grafted regions, a high percentage of lucencies at the graft-porous interface implies a lack of bone ingrowth. The authors were unable to characterize any roentgenographic behavioral differences between allograft or autograft. The approach is successful in severely deficient acetabulae, especially of the Type III combined cavitary and segmental medial wall deficiency.     

Ingrowth of bone in failed fixation of porous-coated femoral components

In five straight-stemmed, proximally porous-coated femoral components that were retrieved at revision arthroplasty from patients who had radiographic and clinical evidence of loosening, there was growth of bone into the porous coating. The components had been inserted during a primary arthroplasty in one woman and four men. The patients ranged in age from thirty-seven to sixty-seven years. Three patients were heavy, and all five were active. All patients had had an excellent early result from the initial arthroplasty; at the one-year follow-up, the mean Harris hip score had been 91 points. Pain in the hip developed in all of the patients, between one and three years after the index procedure. Initial radiographs had revealed excellent position and fixation of the prosthetic components, but the components then subsided between one and three and one-half years after the index procedure. All of the femoral components were found to be grossly loose at the revision operation. Nevertheless, all of the prosthetic components demonstrated growth of bone into 4 to 44 per cent (mean, 24 per cent) of the pore spaces available for ingrowth. Woven bone and fracture callus were found in the curettings from the proximal part of the femur. The findings in these five patients suggest that late failure of uncemented porous-surfaced femoral components can occur despite the presence of extensive ingrowth of bone. These failures may be the result of fatigue fractures of the trabeculae of the osseous ingrowth into the porous surfaces. Caution is warranted in the liberal use of these prosthetic components in heavy, active patients.     

A long-term study on defect filling and bone ingrowth using a canine fiber metal total hip model.

When performing primary and revision total hip arthroplasty (THA), bone defects are often encountered. At present, grafting osseous defects with autogeneic bone is a common means of treatment. In this study, defects in bone were created in the femora and acetabula of dogs being treated with cementless THA with a fiber metal implant (Group A) or a hydroxyapatite tricalcium phosphate (HA/TCP) sprayed implant (Group B). The following methods of defect filling were compared: (1) leaving defects unfilled, (2) filling with autogeneic bone graft, (3) filling with a 50:50 mixture of autograft and a biphasic ceramic composed of HA/TCP, and (4) filling with a collagen-HA/TCP-bone marrow mixture. Analysis of defect healing and the extent of ingrowth into the overlying fiber metal, at defect sites and sites distant from defects, was made at six, 12, and 24 weeks postimplantation. Defect healing was enhanced at six and 12 weeks in all grafted groups when compared with ungrafted controls. Bone ingrowth into the porous fiber metal overlying the defects was not significantly affected by grafting the defects, compared with the ungrafted defects. The extent of bone ingrowth into the fiber metal acetabular implant at sites away from the defects increased during the entire study. In contrast, the extent of bone ingrowth on the femoral side was maximal at 12 weeks. The HA/TCP coating enhanced ingrowth into the acetabular component at 12 weeks, compared with the uncoated prosthesis, but did not enhance ingrowth on the femoral side. The data from this study demonstrate that defect healing is enhanced with graft materials. However, this does not necessarily result in increased ingrowth into porous surfaces overlying osseous defects. General bone ingrowth and ingrowth at defect sites at 12 weeks postimplantation can be enhanced on the acetabular side with the use of HA/TCP-sprayed implants. However, no positive effect is seen with the use of an HA/TCP-sprayed femoral implant.     

Rinsing morselized allografts improves bone and tissue ingrowth

Bone defects in revision hip surgery can be reconstructed with impacted morselized bone grafts. Rinsing these trabecular allografts may enhance graft incorporation by washing out immunogenic factors present in blood, marrow, and fat. However, it has been proposed that impaction of the graft releases biologically active factors, which can provide sufficient activity to stimulate new bone formation. Rinsing before impaction could enhance bone allograft incorporation, but rinsing after impaction could diminish the incorporation process of impacted bone graft. To study the effect of rinsing and impaction of morselized bone grafts on bone ingrowth, a bone chamber study was done in goats. Autografts and allografts were divided into three treatment groups: (A) impacted; (B) rinsed and impacted; and (C) rinsed, impacted, rinsed, and impacted again. Ten goats received three bone chambers in each proximal tibia. The chambers were filled with either allograft or autograft, yielding six different implants per goat. After 6 weeks, histologic analyses were done and bone and tissue ingrowth were measured. New bone and total tissue ingrowth were higher in autografts than in allografts, especially in the nonrinsed group. With rinsing, total tissue ingrowth increased in the allograft group to approach that of autografts. Rinsing after impaction did not additionally alter bone ingrowth. The current findings show that incorporation of allografts can be improved by rinsing the grafts before impaction.     

Centrifugation as a method of improving tensile and fatigue properties of acrylic bone cement

In this study centrifugation dramatically reduced the porosity and substantially increased the mechanical properties of bone cement. Monotonic tensile tests to failure of centrifuged specimens of cement demonstrated an increase of 24 per cent in the mean ultimate tensile strength compared with the control value. Mean ultimate tensile strain was improved by 54 per cent. In fully reversed tension-compression fatigue-testing, centrifugation resulted in a mean increase in fatigue life of 136 per cent. These strong advantages in mechanical properties were obtained without any detrimental changes. There was no change in elastic modulus, setting time, or peak temperature. Handling properties were improved. There was no increase in systemic toxicity as demonstrated in dogs by assessment of arterial blood-pressure response and peak levels of monomer in the serum during simulated total hip arthroplasty. We also present a practical system of cement centrifugation and delivery that is suitable for use in the operating room.     

Total hip arthroplasty with bulk femoral head autograft for acetabular reconstruction in developmental dysplasia of the hip

BACKGROUND: The long-term results of total hip arthroplasty performed with cement and use of a bulk autograft for acetabular reconstruction in patients with developmental dysplasia of the hip have varied considerably. We evaluated the results of total hip arthroplasties performed with acetabular bulk autograft to identify the factors that influence the results of this procedure. METHODS: Acetabular roof defects secondary to developmental dysplasia of the hip were reconstructed with a bulk femoral head autograft at the time of total hip arthroplasties performed with use of the Charnley technique and prosthesis. Thirty-seven hips in thirty patients (mean age at the time of the operation, fifty-seven years) were followed for ten to twenty-six years (mean, nineteen years). The Crowe classification of hip subluxation or dislocation was Group II for sixteen hips, Group III for seventeen, and Group IV for four. RESULTS: Coverage of the socket by the graft ranged from 5% to 49% (mean, 33%). Twenty-nine sockets were located within the true acetabulum, and eight were placed more proximally. At the time of the latest follow-up, all of the patients had an excellent clinical result, all of the grafts had united, and no hip had radiographic evidence of failure of the fixation. CONCLUSIONS: We found that total hip arthroplasty performed with cement and use of a bulk autograft to reconstruct an acetabulum with severe bone deficiency secondary to developmental dysplasia of the hip can provide long-term success in patients forty-eight years of age and older when coverage of the socket by the graft does not exceed 50%. When it is not possible to achieve >50% coverage of the socket by the ilium at the level of the true acetabulum, more proximal placement of the socket to obtain adequate coverage is recommended.     

Femoral head autograft in simultaneous primary and revision total hip arthroplasty

Bilateral total hip arthroplasty during one anesthetic procedure can be beneficial in properly selected patients. For patients who have a failed hip arthroplasty requiring revision and a contralateral arthritic hip requiring primary arthroplasty, bilateral surgery permits the resected femoral head from the primary procedure to be used as a fresh autogenous bone—graft during the revision procedure. Four patients underwent combined primary hip arthroplasty and contralateral revision hip arthroplasty during one anesthetic procedure. The femoral head obtained during the primary procedure was used as a structural acetabular bone—graft in three patients, and bone slurry was used to fill cavitary acetabular defects in one patient. A femoral neck autograft was used to reconstruct a calcar defect in one of the patients. After an average follow-up period of 27 months, all hips were functioning well with healed bone—grafts and stable prosthetic components.     

Revision of the acetabular component without cement after a previous acetabular reconstruction with use of a bulk femoral head graft in patients who had congenital dislocation or dysplasia. A follow-up note

BACKGROUND: Revision of an acetabular component that has failed after a total hip arthroplasty in which a bulk femoral head autogenous graft or allograft was used as a structural graft for acetabular reconstruction is an uncommon but complex and challenging procedure. We previously reported the results for seventy hips at an average of 16.5 years after a total hip arthroplasty in which an acetabular reconstruction had been performed with a femoral head graft. In the present study, we evaluated a subset of nine hips from that series that had a subsequent revision of the acetabular component without cement. The purpose of the current study was to assess the usefulness of the bone graft in this revision. METHODS: The nine patients (nine hips) were followed clinically and radiographically for an average of seventy-six months (range, sixty-one to 114 months) after the index revision. In six hips the autogenous femoral head graft previously had been bolted to the lateral side of the ilium, and in one hip the femoral head allograft had been affixed in this manner. In the two remaining hips, the allograft had been placed within the acetabulum. The hips were classified according to the extent of acetabular bone loss, with use of criteria described previously. Three hips had stage-I bone loss; four, stage-II; and two, stage-IIB. A porous-coated hemispherical acetabular component was inserted without cement and fixed with screws in each hip. At least 70 percent of the porous coating was in contact with viable bone. RESULTS: At the time of the latest follow-up after the index revision, all nine acetabular components were functioning well without loosening or osteolysis and none had been revised. The average Harris hip score was 77 points (range, 61 to 98 points) compared with 49 points (range, 27 to 96 points) preoperatively. One hip had had revision of the femoral stem, and another had had exchange of the acetabular liner because of recurrent dislocations. There was no additional resorption of the residual bulk graft that was in contact with the metal shell in any hip. CONCLUSIONS: In this small series of complex acetabular revisions, the healed bulk graft provided valuable additional bone stock for the support of an acetabular component that was inserted without cement. Insertion of the acetabular component into the available bone, which consisted in major part of host bone and in minor part of united revascularized bulk graft, resulted in a well functioning hip after an intermediate duration of follow-up. In all except two hips, the enlarged bone stock allowed insertion of a larger acetabular component than had been used previously.     

Circumferential allograft replacement of the proximal femur. A critical analysis

The use of proximal femoral structural allografts in revision hip arthroplasty remains controversial. The current study constitutes the mean 8.8 years followup (range, 3-12.5 years) of a consecutive series of 55 proximal femoral allografts in 51 patients. In 46 patients the implant was cemented into the allograft and the distal femur, and the host proximal femur was resected at the time of reconstruction in all but seven patients. Five patients underwent revision surgery for acetabular failure, and six additional patients underwent revision surgery for failure of the proximal femoral allograft. Three patients underwent successful revision surgery and had additional proximal femoral allografts. Failure was caused by graft fracture in one patient, by deep infection in two patients, and by junctional nonunion in three patients. Junctional nonunion was seen in five patients (9%), two of whom were treated successfully with bone grafting and bone grafting and plating, respectively. Instability was observed in six patients (11%). Trochanteric nonunion was seen in 22 patients (43%) and trochanteric escape was seen in 14 patients (27%). The mean Harris hip score improved from 39 to 79 points. Resorption involving the full thickness of the allograft in at least one zone was seen in seven patients. This progressed rapidly and silently within the first 3 years but has yet to lead to the failure of any of the reconstructions. Infection was ruled out in every case. Allograft resorption was seen in seven patients and may be related to a combination of factors. It is most likely that this is an immunologic problem of slow rejection, but it is possible that the distal cement fixation led to stress shielding and resorption attributable to mechanical disuse. The possible protective role of retaining the bivalved host bone as a vascularized onlay autograft remains to be clarified. Although these results justify the continued use of structural allografts for selected patients, continued followup is warranted.     

嵌压植骨技术在人工全髋关节翻修术中的应用

目的 探讨使用嵌压植骨技术进行全髋关节翻修术的临床效果。方法1998年12月至2003年9月,采用嵌压植骨技术对48例患者72侧髋关节进行了翻修,平均随访时间25个月,采用Harris评分及X线片观察进行临床疗效评定,并统计并发症的发生率。结果Harris评分从术前平均44．6分提高到术后87．4分,术后优良率为达90．3％;无假体松动及下沉;股骨骨折发生率为4．2％;关节脱位率为1．4％,感染率为1．4％。结论嵌压植骨技术是一种有效重建髋关节置换术后松动所致严重骨缺损的方法。采用冻干异体骨植骨及解剖柄股骨假体同样可以获得满意的临床效果。     

Proximally porous-coated ingrowth prostheses: limits of use

Callaghan has suggested that the most important factor in obtaining optimal results after total hip arthroplasty may be the ability to determine when to use cemented or cementless fixation. This article has presented the indications and relative contraindications for use of proximally porous-coated prostheses. Midterm results suggest that with appropriate patient selection, excellent clinical results can be achieved with currently available proximally porous-coated prostheses. Use of proximally coated prostheses is indicated for primary total hip arthroplasty in patients aged >70 years with good bone stock. Relative contraindications are based on interference with bone ingrowth or with the ability to achieve a congruent fit, both of which preclude establishment of rigid initial stability. These conditions include metabolic bone disease such as osteoporosis, osteomalacia, Gaucher's disease, sickle cell disorders, and Paget's disease; significant anatomical distortion, as seen in developmental dysplasia of the hip with anteversion, prior osteotomy, or intertrochanteric fracture; Dorr type C bone; and current treatment with radiation, chemotherapy, indomethacin, or diphosphonates. The same relative contraindications to use are applicable in revision situations. Further, proximally porous-coated prostheses should not be used for revision arthroplasty in the setting of massive bone loss, limited life expectancy, or inability to participate in protected weight bearing. These devices may be used successfully in revision arthroplasty when the hip has minimal or moderate bone loss, and occasionally in the setting of severe bone loss. As further information is revealed through the long-term (10-20 years) results of proximally coated prostheses, further refinements and knowledge of the indications and contraindications for the use of these prostheses will be revealed.     

Efficacy of autograft and freeze-dried allograft to enhance fixation of porous coated implants in the presence of interface gaps.

Autogenous cancellous bone and freeze-dried allogeneic cancellous bone were tested in a total of 41 adult male mongrel dogs. In each humerus, an implant with a commercially pure titanium fiber metal porous coating was placed in an overreamed cavity so that a uniform 3-mm gap was present between the implant and host cancellous bone. Graft material was placed in the gap of one humerus while the gap of the other humerus was left empty and served as a paired negative control. Histologically, both autograft and allograft appeared to aid repair of the defect, but quantitatively only autograft enhanced new bone formation within the defect. Treatment with autograft significantly increased the amount of bone ingrowth within the implants by nearly three-fold at 4 weeks and eight-fold at 8 weeks. The enhancing effect was recognizable as early as 2 weeks. The strength of fixation was increased by nearly seven-fold at 4 weeks and two-fold at 8 weeks in the autograft group, but this was only statistically significant at 4 weeks. Treatment with allograft did not enhance bone ingrowth at any time period, but had a small positive effect on strength of fixation at 4 weeks.     

The effect of osteogenic protein-1 on the healing of segmental bone defects treated with autograft or allograft bone.

BACKGROUND: Large amounts of bone graft are frequently used to elicit the healing of bone defects resulting from reconstructive procedures. Autograft and allograft bone are often used, but each has its limitations. Bone morphogenetic proteins (BMPs) improve the healing of segmental bone defects treated with autograft or allograft. The objective of the present study was to determine the effect of implantation of a recombinant osteogenic protein-1 (OP-1) in combination with bone graft on the healing of a critical-sized (2.5-cm) segmental defect in canine ulnae. METHODS: Either autograft bone, allograft bone, osteogenic protein-1 (OP-1) mixed with type-1 bovine collagen, or various combinations of OP-1 and collagen (OP-1 device) mixed with allograft or autograft were implanted in the segmental bone defects. The combinations included 67% bone graft with 33% OP-1 device and 33% bone graft with 67% OP-1 device. The healing of the defects was assessed with radiographic, biomechanical, and histological studies. The animals were killed at twelve weeks postoperatively. RESULTS: The use of the OP-1 device alone or any combination of autograft or allograft bone and the OP-1 device demonstrated improved healing on radiographic, mechanical, and histological studies compared with that demonstrated after use of autograft or allograft bone alone. The highest radiographic and histological grades and the greatest mechanical strength were achieved with the use of 33% allograft and 67% OP-1 device, although no significant differences were observed among the different groups containing the OP-1 device. At twelve weeks postoperatively, the defects treated with any amount of the OP-1 device obtained greater mechanical strength than that obtained by autograft bone alone. CONCLUSIONS: Major bone defects may be treated with allograft bone combined with the OP-1 device, instead of autograft alone, to avoid complications associated with the use of autograft. The combination of allograft bone and the OP-1 device resulted in optimum healing of the defect, according to the radiographic, mechanical, and histological parameters measured in this study. CLINICAL RELEVANCE: The combination of freeze-dried allograft bone with the OP-1 device is an attractive graft material for the treatment of large bone defects. Although similar results were observed when autogenous bone graft was used in combination with the OP-1 device, the results of the present study suggest that allograft, because of its relatively unlimited supply, can be substituted without reduced efficacy. In addition, avoiding the need to harvest autogenous bone eliminates the additional operative time and risk associated with a second surgical procedure.