Early Term Effects of rhBMP-2 on Pedicle Screw Fixation in a Sheep Model: Histomorphometric and Biomechanical Analyses

Background: The effects of recombinant human bone morphogenetic protein-2 (rhBMP-2) on pedicle screw pullout force and its potential to improve spinal fixation have not previously been investigated. rhBMP-2 on an absorbable collagen sponge (ACS) carrier was delivered in and around cannulated and fenestrated pedicle screws in a sheep lumbar spine instability model. Two control groups (empty screw and ACS with buffer) were also evaluated. We hypothesized that rhBMP-2 could stimulate bone growth in and around the cannulated and fenestrated pedicle screws to improve early bone purchase. Methods: Eight skeletally mature sheep underwent destabilizing laminectomies at L2–L3 and L4–L5 followed by stabilization with pedicle screw and rod constructs. An ACS carrier was used to deliver 0.15 mg of rhBMP-2 within and around the cannulated and fenestrated titanium pedicle screws. Biomechanics and histomorphometry were used to evaluate the early term results at 6 and 12 postoperative weeks. Results: rhBMP-2 was unable to improve bony purchase of the cannulated and fenestrated pedicle screws compared to both control groups. Although rhBMP-2 groups had pullout forces that were less than both control groups, both rhBMP-2 groups had pullout force values exceeding 2,000 N, which was comparable to previously published results for unmodified pedicle screws. Significant differences in the percentages of bone in peri-screw tissues was not observed amongst the four treatment groups. Microradiography and quantitative histomorphometry showed that at 6 weeks, rhBMP-2 induced peri-screw remodeling regions containing peri-implant bone which was hypodense with respect to surrounding native trabeculae. A moderate correlation between biomechanical pullout variables and histomorphometry data was observed. Conclusions: The design of the cannulated and fenestrated pedicle screw was able to facilitate new bone formation to achieve high pullout forces. However, delivery of rhBMP-2 should be carefully controlled to prevent excessive bone remodeling which could cause early screw loosening

Bioresorbable Polylactide Interbody Implants in an Ovine Anterior Cervical Discectomy and Fusion Model: Three-Year Results

Study Design. In vivo study of anterior discectomy and fusion using a bioresorbable 70:30 poly(l-lactide-co-d,l-lactide) interbody implant in an ovine model. Objective. To evaluate the efficacy of the polylactide implant to function as an interbody fusion device, and to assess the tissue reaction to the material during the resorption process. Summary of Background Data. The use of polylactide as a cervical interbody implant has several potential advantages when compared with traditional materials. Having an elastic modulus very similar to bone minimizes the potential for stress shielding, and as the material resorbs additional loading is transferred to the developing fusion mass. Although preclinical and clinical studies have demonstrated the suitability of polylactide implants for lumbar interbody fusion, detailed information on cervical anterior cervical discectomy and fusion (ACDF) with polylactide devices is desirable. Methods. Single level ACDF was performed in 8 skeletally mature ewes. Bioresorbable 70:30 poly (l-lactide-co-d,l-lactide) interbody implants packed with autograft were used with single-level metallic plates. Radiographs were made every 3 months up to 1 year, and yearly thereafter. The animals were killed at 6 months (3 animals), 12 months (3 animals), and 36 months (2 animals). In addition to the serial plain radiographs, the specimens were evaluated by nondestructive biomechanical testing and undecalcified histologic analysis. Results. The bioresorbable polylactide implants were effective in achieving interbody fusion. The 6-month animals appeared fused radiographically and biomechanically, whereas histologic sections demonstrated partial fusion (in 3 of 3 animals). Radiographic fusion was confirmed histologically and biomechanically at 12 months (3 of 3 animals) and 36 months (2 of 2 animals). A mild chronic inflammatory response to the resorbing polylactide implant was observed at both 6 months and 12 months. At 36 months, the operative levels were solidly fused and the implants were completely resorbed. No adverse tissue response was observed in any animal at any time period. Conclusion. Interbody fusion was achieved using bioresorbable polylactide implants, with no evidence of implant collapse, extrusion, or adverse tissue response to the material. The use of polylactide as a cervical interbody device appears both safe and effective based on these ACDF animal model results

Instrumented Lumbar Corpectomy and Spinal Reconstruction Comparing rhBMP-2/Compression-Resistant Matrix, rhBMP-2/Absorbable Collagen Sponge/Ceramic Granules Mixture, and Autograft in Two Different Devices: A Study in Sheep

Study Design. Fusion success with rhBMP-2 and autograft in titanium or PEEK corpectomy devices was evaluated in a sheep lumbar corpectomy model. The 6 treatment groups included titanium mesh or PEEK corpectomy devices filled with rhBMP-2 on a compression-resistant matrix (CRM) carrier; rhBMP-2 in a morselized absorbable collagen sponge (ACS) carrier combined with resorbable ceramic granules; and autograft. Objective. The aim of this study was to determine fusion rates associated with 2 different preparations of rhBMP-2 as well as autograft in an instrumented ovine lumbar corpectomy model 6 months postoperatively. Summary of Background Data. Vertebral reconstruction with corpectomy devices requires bone graft. Bone graft substitutes have the potential to avoid a second operation, donor site pain, and attendant morbidity associated with autograft. Methods. Twenty-four sheep in 6 treatment groups underwent lumbar corpectomy via a retroperitoneal trans-psoas approach. Spines were reconstructed with autograft, rhBMP-2 on a CRM, or rhBMP-2 on an ACS mixed with ceramic granules. Grafting materials were placed in either a titanium mesh or PEEK conduit in spines with internal fixation. Computed tomographic (CT) scans were evaluated for fusion. Undecalcified histology was used to evaluate for fusion as well as the amount and extent of graft incorporation and graft resorption. Results. Regardless of corpectomy device used, rhBMP-2/CRM or rhBMP-2/ACS with MASTERGRAFT resulted in a 100% fusion rate. The autograft group had a lower (75%) radiographic fusion rate. Using either preparation of rhBMP-2 resulted in the length of the defect filling with solid bone. Autograft fragments and ceramic granules were incorporated into the fusion masses with much of the ceramic granules being resorbed by 6 months. Conclusion. Both of the rhBMP-2 formulations have the potential to effect bony fusion and vertebral reconstruction within the corpectomy devices

Knee surgery complications related to biomaterials

Recent years have seen a growing interest in biomaterials and use of these materials in the clinical setting is increasing. Despite their advantages, they have also been cited as the source of specific complications and/or fail- ures. Problems such as screw breakage, tunnel enlargement, allergic or foreign body reactions, cyst and abscess formation, or even delayed migration of supposedly biodegradable screws/implants have been reported. This chapter aims to review the basic science and clinical experience with biomaterials currently employed in fixation devices for knee surgery. Information on the clinical implications of biodegradable screws is still limited. Surgeons tend to focus more on the emerging successes of innovations than on the complications and failures (publication bias) of older devices, making it difficult to reliably assess the incidence of such events. More- over, the complexity of possible reactions occurring in the human body cannot be reproduced under controlled laboratory conditions.Neverthe- less, surgeons and patients must be aware of both the advantages and the complications of these devices. Only in this way can informed choices be made, so that both parties are prepared to face and overcome the unde- sired complications, and the improvement of future implants can become a reality

Effect of sonic hedgehog/β-TCP composites on bone healing within the critical-sized rat femoral defect

The creation of entirely synthetically derived bone substitute materials which are as effective as autologous bone grafts is desirable. Osteogenesis involves the concerted action of several proteins within a signaling cascade. Hedgehog proteins act upstream of this cascade, inducing the expression of various bone morphogenetic proteins (BMPs) and promoting physiological bone healing. Therefore, the hypothesis that hedgehog signaling in bone defects improves bone healing more than BMP signaling alone was tested. Recombinant N-terminal sonic hedgehog protein (N-SHh), BMP-2 or a combination of the two was added to β-tricalcium phosphate (β-TCP) and 5-mm femoral midshaft defects in nude rats were filled with these composites. The defects were stabilized with mini-plates. After eight weeks, the animals were sacrificed and the femora were explanted. The radiological evaluation was followed by a three-point bending test and histological examination. BMP-2/β-TCP composites showed a trend of increased stiffness compared with the controls (β-TCP without protein). N-SHh/β-TCP composites had lower stiffness compared with the control group and the N-SHh/BMP-2/β-TCP composites also had lower average stiffness compared with the controls (all not significant). Histomorphometry, however, revealed abundant cartilage and bone core formation in the N-SHh-composite groups. The sum of the new cartilage and bone was highest in the combination group N-SHh/BMP-2 (not significant). The addition of N-SHh to bone substitute materials appears to delay bone healing at the applied concentration and observation time but also showed a trend for higher amounts of ossifying cartilage