Cadaver training module for teaching thoracic pedicle screw placement to residents.

Surgical training using simulators has been shown to be highly effective but is not available for some applications and is too expensive for many programs. The authors piloted a cadaver-based module with the goal of objectively measuring and significantly improving orthopedic residents' surgical skills in placing thoracic pedicle screws, an advanced procedure. An experienced spine surgeon placed thoracic pedicle screws in 7 cadavers (T1-T12) to establish the skilled accuracy rate. For this pilot study, 3 orthopedic residents unfamiliar with the procedure were given didactic training for safe thoracic pedicle screw insertion. Each resident instrumented alternating sides of 5 consecutive cadavers (T1-T12). Screw positions were graded by computed tomography in a blinded fashion, with accuracy defined as no shank breach of the pedicle or vertebral body. Results were reviewed with the residents, instruction was repeated, and alternating sides of 5 cadavers were instrumented by the residents. The experienced surgeon accurately placed 67 (82%) of 82 pedicle screws. Residents accurately placed 80 (44%) of 180 pedicle screws in the initial set of specimens and 105 (58%) of 180 pedicle screws in the second set of specimens (P=.01). Accuracy varied significantly among residents before but not after computed tomography review. The study's results show that a cadaver-based training module that resembles the clinical setting can be used to teach complex surgical skills to orthopedic residents.

Autologous growth factors versus autogenous graft for anterior cervical interbody fusion: an in vivo caprine model.

OBJECT: Using an in vivo caprine model, authors in this study compared the efficacy of autologous growth factors (AGFs) with autogenous graft for anterior cervical interbody arthrodesis. METHODS: Fourteen skeletally mature Nubian goats were used in this study and followed up for a period of 16 weeks postoperatively. Anterior cervical interbody arthrodesis was performed at the C3-4 and C5-6 vertebral levels. Four interbody treatment groups (7 animals in each group) were equally randomized among the 28 arthrodesis sites: Group 1, autograft alone; Group 2, autograft + cervical cage; Group 3, AGFs + cervical cage; and Group 4, autograft + anterior cervical plate. Groups 1 and 4 served as operative controls. Autologous growth factors were obtained preoperatively from venous blood and were ultra-concentrated. Following the 16-week survival period, interbody fusion success was evaluated based on radiographic, biomechanical, and histological analyses. RESULTS: All goats survived surgery without incidence of vascular or infectious complications. Radiographic analysis by 3 independent observers indicated fusion rates ranging from 9 (43%) of 21 in the autograft-alone and autograft + cage groups to 12 (57%) of 21 in the autograft + anterior plate group. The sample size was not large enough to detect any statistical significance in these observed differences. Biomechanical testing revealed statistical differences (p < 0.05) between all treatments and the nonoperative controls under axial rotation and flexion and extension loading. Although the AGF + cage and autograft-alone treatments appeared to be statistically different from the intact spine during lateral bending, larger variances and smaller relative differences precluded a determination of statistical significance. Histomorphometric analysis of bone formation within the predefined fusion zone indicated quantities of bone within the interbody cage ranging from 21.3 +/- 14.7% for the AGF + cage group to 34.5 +/- 9.9% for the autograft-alone group. CONCLUSIONS: The results indicated no differences in biomechanical findings among the treatment groups and comparable levels of trabecular bone formation within the fusion site between specimens treated with autogenous bone and those filled with the ultra-concentrated AGF extract. In addition, interbody cage treatments appeared to maintain disc space height better than autograft-alone treatments.

Biomechanical comparison of iliac screws versus interbody femoral ring allograft on lumbosacral kinematics and sacral screw strain.

STUDY DESIGN: This study evaluates the effect of iliac screw fixation versus interbody femoral ring allograft (FRA) on lumbosacral kinematics and sacral screw strain in long segment instrumentations. OBJECTIVE: (1) Quantify kinematic properties of 3 lumbosacral fixation techniques; (2) Evaluate sacral screw strain as instrumented levels extend cephalad; and (3) Determine whether iliac screws or FRA biomechanically protect sacral screws. SUMMARY OF BACKGROUND DATA: High failure rates at the lumbosacral junction have been reported with long posterior instrumentation ending with S1 pedicle screws. Achieving lumbosacral arthrodesis remains a clinical challenge. METHODS: Seven human cadavaric lumbosacral spines were biomechanically evaluated intact and in 3 instrumented conditions: pedicle screw fixation alone (pedicle screw group), pedicle screw fixation supplemented with iliac screws (iliac screw group), and pedicle screw fixation supplemented with FRA (allograft group). Each condition was tested spanning L5-S1, L4-S1, L3-S1, L2-S1, and L1-S1. Testing included pure unconstrained moments (±10 Nm) in axial rotation, flexion/extension, and lateral bending, with quantification of S1 screw strain and lumbosacral range of motion (ROM). RESULTS: Testing revealed decreasing lumbosacral ROM as instrumentation extended cephalad (P < 0.05). In axial rotation, ROM was markedly higher for the allograft group compared to pedicle screw and iliac screw groups with instrumentation to L4 (P < 0.05). In flexion/extension, length of instrumentation in each group correlated with ROM. As length of instrumentation increased, ROM decreased, particularly for the iliac screw group. In lateral bending, ROM decreased in all groups as instrumentation lengthened (P < 0.05). Strain on unprotected sacral screws increased in flexion, extension, and lateral bending as instrumentation extended to L3 (P < 0.05). Iliac screws reduced strain in constructs to L3 and above (P < 0.05). Allograft reduced strain when fixation reached L2, but was not as effective as iliac screws overall. Neither iliac screws nor allograft reduced strain in constructs terminating at L5 or L4. (P > 0.05) CONCLUSION.: For instrumented fusions extending above L3, sacral screws should be protected with supplemental iliac screws or FRA at L5-S1. Of the two, iliac screws appear more effective.

Revision strategies for single- and two-level total disc arthroplasty procedures: a biomechanical perspective.

BACKGROUND CONTEXT: The utilization of motion-preserving implants versus conventional instrumentation systems, which stabilize the operative segments, necessitates improved understanding of their comparative biomechanical properties and optimal biomechanical method for surgical revision. PURPOSE: Using an in vitro human cadaveric model, the primary objective was to compare the multidirectional flexibility properties of single- versus two-level total disc arthroplasty procedures and determine the acute in vitro biomechanical characteristics of two methods of surgical revision-posterior transpedicular instrumentation alone or circumferential spinal arthrodesis. STUDY DESIGN: This in vitro biomechanical study was undertaken to compare the multidirectional flexibility kinematics of single- versus two-level lumbar total disc arthroplasty reconstructions using an in vitro model. METHODS: A total of seven human cadaveric lumbosacral spines (L1-sacrum) were biomechanically evaluated under the following L4-L5 reconstruction conditions: intact spine; discectomy alone; Charité total disc replacement; Charité with pedicle screws; two-level Charité (L4-S1); two-level Charité with pedicle screws (L4-S1); Charité L4-L5 with pedicle screws and femoral ring allograft (FRA) (L5-S1); and pedicle screws with FRA (L4-S1). Multidirectional flexibility testing used the Panjabi Hybrid Testing protocol, which includes pure moments for the intact condition with the overall spinal motion replicated under displacement control for subsequent reconstructions. Hence, changes in adjacent level kinematics can be obtained compared with pure moment testing strategies. Unconstrained intact moments of +/-7.5Nm were used for axial rotation, flexion-extension, and lateral bending testing with quantification of the operative- and adjacent-level range of motion (ROM). All data were normalized to the intact spine condition (intact=100%). RESULTS: In axial rotation, single- and two-level Charité reconstructions produced significantly more motion than pedicle screw constructs combined with the Charité or FRA (p<.05). There were no differences between the Charité augmented with pedicle screws or pedicle screws with FRA (p>.05). The two-level annulus lumbar resection required for multilevel Charité implantation had an added destabilizing effect, resulting in a 140% to 160% ROM increase over the intact condition. Under two-level reconstructions, rotational motion at the L4-L5 level increased from 160+/-26% to 263+/-65% with the implantation of the second Charité at L5-S1. Flexion-extension and lateral bending conditions with the Charité reconstructions in this group of seven spines demonstrated no significant differences compared with the intact spine (p>.05). The Charité combined with pedicle screws or pedicle screws with FRA significantly reduced motion at the operative level compared with the Charité reconstruction (p<.05). The most pronounced changes in adjacent level kinematics and intradiscal pressures were observed under flexion-extension loading. The addition of pedicle screw fixation increased segmental motion and intradiscal pressures at the proximal and distal adjacent levels compared with the intact and Charité reconstruction groups (p<.05). CONCLUSIONS: The findings highlight a variety of important trends at the operative and adjacent levels. In terms of revision strategies, posterior pedicle screw reconstruction combined with an existing Charité was not found acutely to be statistically different from pedicle screws combined with FRA.

100 consecutive cases of degenerative lumbar conditions using a non-threaded locking screw system with a 90-degree locking cap.

BACKGROUND: This prospective study analyzes the perioperative outcomes and long-term fusion success of 100 consecutive lumbar degenerative cases. The cases were managed using a non-threaded locking screw system, in conjunction with polyetheretherketone (PEEK) cages, for posterior lumbar interbody fusion (PLIF) procedures. These 100 cases were compared to another prospective study treating patients with the same inclusion and exclusion criteria using conventional plate-based pedicle screw spinal instrumentation augmented with carbon fiber interbody cages. METHODS: A total of 167 operative levels were treated in 100 patients (51 single-level, 39 two-level and 10 three-level cases). Eleven cases were revisions and 67 patients received interbody fusion cages. Patients had an average of 22.8 ± 4.0 months followup. RESULTS: There was one instrumentation failure but no significant subsidence at the interbody fusion level. The disc space height was restored as part of the surgical procedure at the interbody cage levels: from 7.5 ± 2.3 mm preoperative to 9.0 ± 2.1 mm postoperative. There were 2 cases of pseudarthrosis (2 / 100 = 2%). The average operative time for 1-level cases was 111 ± 25 minutes; for 2-level cases it was 132.4 ± 21.8 minutes; and for 3-level cases it was 162.6 ± 33 minutes. Blood loss averaged 800 ± 473 cc for 1-level cases, 1055 ± 408 cc for 2 levels, and 1155 ± 714 cc for 3 levels. The length of stay was similar between the 3 groups (4.4 ± 1.2 days for single-level cases, 4.7 ± 1.1 for 2 levels, and 5.0 ± 1.1 for 3 levels; P > .05). There were 3 incidental durotomies, and 4 other patients developed infections postoperatively that required reoperation. CONCLUSION: The disc and foraminal heights can be restored and maintained with a unilateral cage and pedicle screw construct. Unilateral transforaminal lumbar interbody fusion using a PEEK cage combined with a non-threaded locking pedicle screw and rod system results in similar fusion rates to those achieved using the bilateral Brantigan interbody fusion cage or a single BAK Vista implant. When compared to the bilateral Brantigan cages, decreased operative time (P < .001), decreased blood loss (P < .001) and reduced incidence of dural tears (P < .001) are advantages of using a non-threaded locking screw system and single PEEK interbody cage for lumbar degenerative conditions without compromising subsequent fusion rates.

Biomechanical analysis of rotational motions after disc arthroplasty: implications for patients with adult deformities.

STUDY DESIGN: An anatomic and biomechanical bench-top basic scientific comparative analysis to determine the appropriateness of total disc replacement (TDR) in a lumbar spine with scoliotic tendencies. OBJECTIVES: Only limited data are currently available studying the application of disc replacement adjacent to scoliosis fusions. Theoretically, motion preservation should help delay the continuum of lumbar degeneration adjacent to scoliosis fusions and rotationally unstable lumbar segments. SUMMARY OF BACKGROUND DATA: As a tertiary referral center for failed TDR, we noticed an alarming number of lumbar spinal rotational iatrogenic instability patterns but none occurring in the cervical spine. It is appropriate to analyze the bench-top rotational stability of disc replacement to predict whether this new technology is feasible for a larger prospective clinical study in the treatment of degenerative scoliosis. METHODS: Measurements were taken from 60 human specimens from the Hamann-Todd Osteological Collection: 1) to determine the rotational arc of influence (AOI) = the angle formed from the center of axial rotation to the outermost extent of the facet joints; and 2) to determine the relative anatomic size discrepancy between the left and right facets proportionately with the cross-sectional area of the intervertebral disc = facet/endplate ratio (FER). Biomechanical testing was performed using fresh frozen human cadaveric spines with the following conditions to determine the rotational stability: 1) intact; 2) resection of ALL, anulus, disc, and PLL simulating the preparation for a TDR; 3) a more radical anular resection; 4) entire 360 degrees anular resection; and 4) insertion of the respective unconstrained-type disc replacement. Using a 6 degrees of freedom spine simulator, unconstrained pure moments of +/-8.0 Nm (lumbar) and +/-3.0 Nm (cervical) were used for axial rotation with quantification of the operative level range of motion and neutral zone, with data normalized to the intact spine condition. RESULTS: There were anatomic limitations in the lumbar spine that make it less desirable to apply uncon-strained disc replacements; indeed, the spine was at risk for iatrogenic lumbar scoliosis. The anulus fibrosis, anterior longitudinal ligament, and the posterior longitudinal ligament are critical structures in preventing iatrogenic scoliosis. The lumbar facet joints are more posteriorly located and are smaller relative to the intervertebral disc, compared with this association in the cervical spine. Because the facet capsular ligaments are mechanically less effective with lower tensile strength in the lumbar spine, multiple-level arthroplasty tends to accentuate scoliotic tendencies; this is independent of prosthetic design and surgical technique. DISCUSSION: Implantation of the lumbar TDR never restored the motion segment back to the rotational stability of the intact segment achieving a range of 120% to 140% rotational range of motion compared with the intact condition. This rotational instability proved to be additive as a two-level lumbar TDR resulted in between 240% and 260% increase in rotational instability compared with the intact condition. CONCLUSION: The neutral zone of the intact cervical spine was restored even using an unconstrained cervical TDR. The greater inherent rotational constraints of the cervical spine make it more amenable to stable multilevel arthroplasty compared with the lumbar spine.

Porous coated motion cervical disc replacement: a biomechanical, histomorphometric, and biologic wear analysis in a caprine model.

STUDY DESIGN: The biomechanical, histopathologic, and histomorphometric characteristics of cervical disc replacement were assessed in a caprine animal model. OBJECTIVE: To investigate the biomechanical, porous ingrowth, and histopathologic characteristics of the Porous Coated Motion (PCM) Cervical Disc replacement (Cervitech, Inc., Rockaway, NJ). SUMMARY OF BACKGROUND DATA: As an alternative to anterior cervical interbody arthrodesis, an artificial cervical disc serves to replace the symptomatic degenerated disc, restore the functional biomechanical properties of the motion segment, and preserve neurologic function. METHODS: There were 12 mature Nubian goats divided into 2 groups based on postoperative survival periods of 6 (n = 6) and 12 months (n = 6). Using an anterior surgical approach, a complete discectomy was performed at the C3-C4, followed by implantation of the PCM device. Functional outcomes of the disc prosthesis were based on computerized tomography (CT), multidirectional flexibility testing, undecalcified histology, histomorphometric, and immunocytochemical analyses. RESULTS: There was no evidence of prosthesis loosening, or neurologic or vascular complications. CT showed the ability to image and assess the cervical spinal canal for the presence of compressive pathology in the area of the CoCrMo prosthesis. Multidirectional flexibility testing under axial rotation and lateral bending indicated no differences in the full range of intervertebral motion between the disc prosthesis and nonoperative controls (P > 0.05). Based on immunohistochemical and histologic analysis, there was no evidence of particulate debris, cytokines, or cellular apoptosis within the local or systemic tissues. Moreover, review of the spinal cord at the operative levels indicated no evidence of cord lesions, inflammatory reaction, wear particles, or significant pathologic changes in any treatment. Histomorphometric analysis at the metal-bone interface indicated the mean trabecular ingrowth of 40.5% +/- 24.4% and 58.65% +/- 28.04% for the 6 and 12-month treatments, respectively. CONCLUSION: To our knowledge, this serves as the first in vivo time-course study investigating the use of the PCM device for cervical arthroplasty. All 12 animals undergoing cervical disc replacement had no evidence of implant loosening, subluxation, or inflammatory reactions. PCM cervical arthroplasty permits unobstructed visualization of the spinal canal based on CT imaging. Segmental intervertebral motion was preserved under axial rotation and lateral bending loading conditions, while at the same time permitting porous osseointegration at the prosthesis-bone interface. Based on histopathologic review of all local and systemic tissues, there was no evidence of particulate wear debris, cytokines, cellular apoptosis, or significant pathologic changes in any treatment.

The effect of spinal instrumentation particulate wear debris. an in vivo rabbit model and applied clinical study of retrieved instrumentation cases.

STUDY DESIGN: The current study was undertaken to determine if the presence of spinal instrumentation wear particulate debris deleteriously influences early osseointegration of posterolateral bone graft or disrupts an established posterolateral fusion mass. OBJECTIVES: Using an in vivo animal model, the first phase (basic science) of this study was to evaluate the effect(s) of titanium wear particulate on a posterolateral spinal arthrodesis based on serological, histological and immunocytochemical analyses. The second phase (clinical) was to perform the same analysis of soft tissue surrounding spinal instrumentation in 12 symptomatic clinical patients. SUMMARY OF BACKGROUND DATA: The effect of unintended wear particulate resulting from micromotion between the interconnection mechanisms in spinal instrumentation remains a clinical concern. METHODS: Thirty-four New Zealand White rabbits were randomized into two groups based on postoperative time periods of 2 months (Group 1, n=14) and 4 months (Group II, n=20). Group I underwent a posterolateral arthrodesis (PLF) at L5-L6 using tricortical iliac autograft or tricortical iliac autograft plus titanium particulate. Group 2 all received iliac autograft at the initial surgery and were reoperated on after 8 weeks and treated with PLF exposure alone or titanium particulate. Postoperative analysis included serological quantification of systemic cytokines. Postmortem microradiographic, immunocytochemical and histopathological assessment of the intertransverse fusion mass quantified the extent of osteolysis, local proinflammatory cytokines, osteoclasts and inflammatory infiltrates. Clinical aspect of study: Over the last 2 years, 12 patients more than 0.4 years after spinal instrumentation presented with painful paraspinal inflammation. At surgical exploration, the cultures were negative for infection and the surrounding soft tissue was examined for cytokine reactions. There was loosening of implants and osteolysis in the location of the wear debris in 8 of 12 patients. RESULTS: Basic science phase: serological analysis of systemic cytokines indicated no significant differences in cytokine levels (p>.05) between the titanium or autograft treatments. Immunocytochemistry indicated increased levels of local cytokines: TNF-alpha at the titanium-treated PLF sites at both time periods (p<.05). Osteoclast cell counts and regions of osteolytic resorption lacunae were higher in the titanium-treated versus autograft-alone groups (p<.05), and the extent of cellular apoptosis was markedly higher in the titanium-treated sites at both time intervals. Electron microscopy indicated definitive evidence of phagocytized titanium particles and foci of local, chronic inflammatory changes in the titanium-treated sites. Clinical aspect: Eleven of 12 clinical cases demonstrated elevated TNF-alpha levels and an increased osteoclastic response in the vicinity of wear debris caused by dry frictional wear particles of titanium or stainless steel. Osteolysis most commonly involved loose transverse connectors. Resection of the wear debris and surrounding fibroinflammatory glycocalyx resulted in resolution of clinical symptoms in all 12 cases. CONCLUSIONS: Titanium particulate debris introduced at the level of a spinal arthrodesis elicits a cytokine-mediated particulate-induced response favoring proinflammatory infiltrates, increased expression of intracellular TNF-alpha, increased osteoclastic activity and cellular apoptosis. This is the first basic scientific study and the first clinical study demonstrating associations of spinal instrumentation particulates wear debris and increased cytokines and increased osteoclastic activity. Osteolysis is the number one cause of failure of orthopedic implants in the appendicular skeleton. Spinal surgeons need to increase their awareness of this destructive process.

Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model.

STUDY DESIGN: A study was conducted to investigate the biomechanical, histochemical, and biologic ingrowth characteristics of the most widely used total disc prosthesis, the hydroxyapatite-coated SB Charité prosthesis. OBJECTIVE: To compare the porous ingrowth, linear apposition, or bony ingrowth in total disc replacement with published reports of porous ingrowth prostheses in the appendicular skeleton. METHODS: Seven mature baboons (Papio cynocephalus) underwent L5-L6 total disc replacement through an anterior transperitoneal approach. The SB Charité prosthetic vertebral endplates (n = 14) were cobalt-chrome covered by two layers of thin titanium with a hydroxyapatite coating, which was electrochemically bonded to the implant surface. RESULTS: At 6 months after surgery, the range of motion exhibited by the SB Charité and the nonoperative control subjects under axial compression, flexion-extension, and lateral bending showed no statistical difference (P > 0.05). Plain film radiographic analysis showed no lucencies or loosening of any prosthetic vertebral endplate. Gross histopathologic analysis of the hydroxyapatite-coated SB Charité prosthesis demonstrated excellent ingrowth at the level of the implant-bone interface, without evidence of fibrous tissue or synovium. Histochemical assays showed no accumulation of particulate wear debris (no titanium, ultrahigh molecular weight polyethylene, or cobalt-chrome) nor cytokines (tumor necrosis factor-alpha, prostaglandin E2, interleukin-1, -2, or -6). Total endplate area showed a mean ingrowth (volume fraction) of 47.9% +/- 9.12% and a total ingrowth range of 35.5% to 58.8%. CONCLUSIONS: The porous ingrowth (percentage of pore ingrowth coverage at the bone-metal interface) was more favorable for total disc replacement than for cementless total joint components in the appendicular skeleton (range, 10-30%). The reason for the improved degree of porous ingrowth in total disc replacement prostheses probably is that ligamentotaxis causes sustained compression across the metal-bone interface.

The effect of titanium particulate on development and maintenance of a posterolateral spinal arthrodesis: an in vivo rabbit model.

STUDY DESIGN: The current study was undertaken to determine if the presence of titanium wear particulate deleteriously influences early osseointegration of posterolateral bone graft or disrupts an established posterolateral fusion mass. OBJECTIVES: Using an in vivo animal model to evaluate the effect(s) of titanium wear particulate on a posterolateral spinal arthrodesis based on serologic, histologic, and immunocytochemical analyses. SUMMARY OF BACKGROUND DATA: The effect of unintended wear particulate resulting from micromotion between the interconnection mechanisms in spinal instrumentation remains a clinical concern. METHODS: Thirty-four New Zealand White rabbits were randomized into two groups based on postoperative time periods of 2 months (Group 1, n = 14) and 4 months (Group 2, n = 20). Group 1 underwent a posterolateral arthrodesis at L5-L6 using tricortical iliac autograft or tricortical iliac autograft + titanium particulate. Group 2 received iliac autograft at the initial surgery and were reoperated on after 8 weeks and treated with posterolateral arthrodesis exposure alone or titanium particulate. Postoperative analysis included serologic quantification of systemic cytokines. Postmortem microradiographic, immunocytochemical, and histopathologic assessment of the intertransverse fusion mass quantified the extent of osteolysis, local pro-inflammatory cytokines, osteoclasts, and inflammatory infiltrates. RESULTS: Serologic analysis of systemic cytokines indicated no significant differences in cytokine levels (P > 0.05) between the titanium or autograft treatments. Immunocytochemistry indicated increased levels of local cytokines (tumor necrosis factor-alpha) at the titanium-treated posterolateral arthrodesis sites at both time periods (P < 0.05). Osteoclast cell counts and regions of osteolytic resorption lacunas were higher in the titanium-treated versus autograft-alone groups (P < 0.05), and the extent of cellular apoptosis was markedly higher in the titanium-treated sites at both time intervals. Electron microscopy indicated definitive evidence of phagocytized titanium particles and foci of local, chronic, inflammatory changes in the titanium-treated sites. CONCLUSION: Titanium particulate debris introduced at the level of a spinal arthrodesis elicits a cytokine-mediated particulate-induced response favoring pro-inflammatory infiltrates, increased expression of intracellular tumor necrosis factor-alpha, increased osteoclastic activity, and cellular apoptosis. The presence of titanium particulate debris, secondary to motion between spinal implants, may serve as the impetus for late-onset inflammatory-infectious complications and long-term osteolysis of an established posterolateral fusion mass in the clinical setting.

Osseointegration of autograft versus osteogenic protein-1 in posterolateral spinal arthrodesis: emphasis on the comparative mechanisms of bone induction.

BACKGROUND CONTEXT: Recent studies have documented increased fusion success afforded by bone morphogenetic proteins versus autogenous graft for posterolateral spinal arthrodesis. PURPOSE: The current study was designed to investigate the time-course maturation processes of lumbar posterolateral arthrodeses performed with Osteogenic Protein-1 (Stryker Biotech, Inc., Hopkinton, MA, USA) (rhOP-1) versus "gold standard" autograft. STUDY DESIGN: The primary focus of this study was to compare the histologic mechanisms of posterolateral osseointegration produced by "hot topic" growth factors. METHODS: A total of 36 coonhounds were equally divided into one of four postoperative time periods of 4, 8, 12 and 24 weeks (nine animals per period). Posterolateral arthrodesis treatments included 1) autograft alone, 2) autograft plus rhOP-1, or 3) rhOP-1 alone. The treatments and animals were divided such that a value of n=6 was obtained for each treatment group per time period and no one animal received the same treatment at both operative sites. Functional spinal unit (FSU) fusion status was assessed using radiographic analysis, biomechanical testing and undecalcified histopathologic and histomorphometric analyses. RESULTS: Radiographic differences in fusion maturation between the treatment groups were evident as early as the 4-week time interval and continued through the 24-week time period. The Osteogenic Protein-1 treatments demonstrated an accelerated rate of radiographic fusion by 4 weeks, which plateaued after the 8-week time period (22% autograft, 88% autograft/rhOP-1 and 66% rhOP-1). In contradistinction, the so-called "gold standard" autograft alone treatments reached a maximum of 50% fusion by the 6-month interval. Biomechanical testing of the FSUs indicated lower flexion-extension and axial rotation range of motion levels for both rhOP-1 treatments versus autograft alone at the 8- and 12-week time periods, respectively (p<.05). Histomorphometric analysis yielded no difference in the posterolateral trabecular bone area (mm(2)) between the three treatments (p>.05), and histopathology indicated no significant histopathologic changes. The most distinctive finding in this study deals with the mechanisms of posterolateral ossification. Based on plain and polarized light microscopy, bone induction and development for the rhOP-1 treatments, with and without autograft, was the result of intramembranous ossification, whereas the process of osseointegration for autograft alone was endochondral bone formation. By the 24-week interval, no discernable differences in trabecular histomorphology were evident based on the different mechanisms of ossification. CONCLUSIONS: This serves as the first study to document the mechanisms of bone induction and fusion maturation between posterolateral arthrodeses treated with autograft versus rhOP-1. The histological data served to corroborate the radiographic and biomechanical findings, because the rhOP-1 treatments consistently demonstrated increased fusion rates and lower range of motion levels compared with the autograft group, particularly at the 8-week postoperative time period. The improvements in these fusion criteria for Osteogenic Protein-1 versus autograft were considered secondary to the differing mechanisms of bone induction. When implanted for posterolateral arthrodesis, rhOP-1 induces an intramembranous healing response, obviating the need for the cartilage intermediate phases found in endochondral bone development. The mechanism of increased speed and incidence of fusion using growth factors (rhOP-1) is delineated by this comprehensive study of preferential intramembranous ossification.