The new compression-resistant biphasic ceramic phosphate/collagen sponge matrices were biologically compatible with recombinant human bone morphogenetic protein 2 bone formation, resulted in biomechanically stiffer fusion masses than autograft, better space maintenance than plain collagen sponges, and improved handling and radiographic resorption properties over the ceramic carriers previously tested.

The addition of either 15:85 BCP granules or allograft bone chips to the existing resorbable collagen sponge matrix enhanced delivery of rhBMP-2 in the posterolateral spine. The combination matrices were more compression resistant and had improved radiographic resorption properties that permitted easy radiographic visualization of new bone. In addition, a lower dose of rhBMP-2 (3 mg/side) was successful compared with the dose previously used with the plain collagen sponge (6 mg/side).

No abstract

The purpose of this study was to characterize the retention kinetics of recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to two calcium-based delivery matrices. Biphasic calcium phosphate (BCP) and a composite containing BCP in an absorbable collagen sponge (BCP/ACS) were evaluated using a spinal fusion model in rabbits. rhBMP-2 labeled with radioactive iodine ('"I) was used as a tracer to assess in vivo retention of rhBMP-2 in the presence of these materials (nine animals per material studied). Over a 36 day study period, animals were assessed for the following: percent administered dose retained at the implant site as measured by scintigraphic imaging (counting) with a gamma camera (all animals), radiography of the implant site (all animals), radioactivity in blood and plasma (all animals), and radioactivity in the urine and feces (three animals for each material). Radioactivity data were corrected for the decay of "' I and the attenuation between the implant in vivo and the gamma camera.Differences observed between the two materials for the area under the retention vs. time profile (AUC; 988Ybday for BCP vs. 1070%*day for BCP/ACS, p = 0.57) and the mean residence time (MRT; 10.2 days for BCP vs. 7.6 days for BCP/ACS, p = 0.06) were not statistically significant. Initial retention/incorporation of rhBMP-2 was slightly higher for rhBMP-2/BCP/ACS than for rhBMP-2/BCP (96.8% vs. 86.O%, p < 0.05). Animals receiving rhBMP-2/BCP showed a longer terminal retention half-life ( t i / * ) than did those receiving rhBMP-2/BCP/ACS (7.5 vs. 4.5 days, p < 0.05). The urinary radioactivity recovery data supported the data obtained by scintigraphy. Over the 36 day collection period, essentially complete recovery of radioactivity (dose) in urine was observed for rhBMP-2/BCP and rhBMP-21BCPIACS and the majority of the radioactivity (approximately 95%)) was soluble in trichloroacetic acid, suggesting extensive catabolism of rhBMP-2 before renal excretion. Fecal recovery of radioactivity was low, approximately 2-3%.In conclusion, rhBMP-2 was retained at the implant site when delivered with either BCP or BCPiACS based on mean residence time and area under the retention curve vs. time profile. Use of these matrices resulted in detectable rhBMP-2 levels at the surgical site for over a week in contrast to data reported with several other matrices that lasted less time. Systemic catabolism and elimination of the rhBMP-2 was extensive and systemic presence of the protein was negligible.

This study shows the importance of carrier optimization and final implant protein concentration for the successful delivery of rhBMP-2. By combining the properties of the ACS with the CRM, the required dosage of rhBMP-2 was diminished by more than 3-fold in the non-human primate model. This finding suggests that the currently available concentration of rhBMP-2 (1.5 mg/mL) could be successful for achieving posterolateral spine fusion when combined with an osteoconductive bulking agent that can support the induced new bone formation.

From the manual palpation, radiographic and biomechanical assessment of fusion, the results in this study showed that INFUSE (rhBMP-2/collagen sponge) consistently produced spine fusion when wrapped around a collagen-ceramic sponge bulking agent (Mastergraft Matrix). Meanwhile, Healos was ineffective as a bone graft material when combined with heparinized autogenous bone marrow.

The purpose of this study was to measure the tensile properties of fresh human calcaneal (Achilles) tendons. Twenty fresh cadaveric (age range = 57-93 years) bone-Achilles tendon complexes were harvested within 24 hr postmortem. The calcaneus together with 15 cm of the Achilles tendon extending proximally from the insertion on the calcaneus was clamped and biomechanically tested. Each tendon was firmly fixed in clamps in an MTS Systems Corporation MTS testing machine and tension was applied at a displacement rate of 8 cm per minute until the tendon failed. The tensile force and tensile strain (as measured using an extensometer) were recorded and plotted using onboard software. The narrow age range of our donors prevented any meaningful correlation between age and tensile properties; however, the results showed that: 1) the average ultimate tensile strength (UTS) of the human Achilles tendon was 1189 N (range = 360-1,965), 2) there was a correlation between left and right legs for UTS, 3) there was a correlation between left and right legs in regard to cross sectional area, and 4) there was no correlation between UTS and cross-sectional area.

The rhesus Matrix formulation performed better than the human Flex. Evidence of osteoinduction was seen in all four monkeys that received Matrix, which improved the fusion success of autograft. This alone suggested that it might play a role as a graft enhancer, not merely as a graft extender. Human studies are warranted.