BACKGROUND CONTEXT: Pseudoarthrosis rates in lumbar intertransverse fusion remain high. Compression and displacement of the developing fusion mass by the paraspinal musculature may be a contributory factor. Biocontainment devices have been clinically used in the skull and mandible to guide bone regeneration. The role of a mechanical device in containing graft material in the developing posterolateral lumbar spine fusion is unclear. PURPOSE: To determine the benefits of using a bioabsorbable graft-containment device for lumbar intertransverse fusion, and to evaluate the biocompatibility of this implant by histological analysis of the host tissue reaction. STUDY DESIGN: A rabbit intertransverse spine fusion model was used to evaluate a bioabsorbable graft-containment implant. Study and control groups were compared with regard to the rate, volume, and quality of fusion, as well as host tissue reaction to the graft and implant. METHODS: Fourteen adult male New Zealand White rabbits underwent bilateral posterolateral intertransverse spine arthrodesis at L3-L4. The control group (n=7) received autograft alone, and the study group received autografts placed in open meshed hemicylinders fashioned from LactoSorb sheets (LactoSorb; Biomet Orthopedics Inc., Warsaw, IN). Spines were harvested at 6 weeks and imaged. Radiographs and computed tomography (CT) images were used to calculate the rate, area, and volume of fusion mass. Sections were fixed and stained with hematoxylin-eosin and Mallory trichrome for histological analysis of fusion and host tissue response. The Mann-Whitney nonparametric statistical test was used for the radiographic and CT qualitative assessments. The CT volume quantitation was analyzed using the Student t test. A p value of <.05 was used to assign statistical significance. RESULTS: The fusion rates on radiographs and CT imaging did not show a significant difference (p>.05) between the biocontainment and control groups. The volume of fusion revealed a significant increase with biocontainment (mean+/-standard error; total left+right fusion sides=2.88+/-0.30 cc) compared with controls (2.12+/-0.15 cc) (p<.05). Histology revealed no difference in the maturity or the quality of the fusion mass between the two groups. Inflammatory response around the developing fusion mass and muscle necrosis were slightly increased in the study group. The LactoSorb biocontainment material led to variable inflammatory reaction, with some areas showing little or no response and other showing an inflammatory response with fibrous connective tissue, lymphocyte infiltration, and focal foreign body giant cell reaction. CONCLUSIONS: The incidence of fusion was similar with or without a containment device for onlay bone graft. A significant increase in the volume of the fusion suggests that a biocontainment device does play a role in protecting the developing fusion mass from the mechanical effects of the paraspinal musculature. The clinical use of this device cannot be justified at this time, and further studies will determine whether this increase in fusion volume will translate into a better incidence and volume of fusion in primate and human models.
BACKGROUND CONTEXT: Pseudoarthrosis rates in lumbar intertransverse fusion remain high. Compression and displacement of the developing fusion mass by the paraspinal musculature may be a contributory factor. Biocontainment devices have been clinically used in the skull and mandible to guide bone regeneration. The role of a mechanical device in containing graft material in the developing posterolateral lumbar spine fusion is unclear. PURPOSE: To determine the benefits of using a bioabsorbable graft-containment device for lumbar intertransverse fusion, and to evaluate the biocompatibility of this implant by histological analysis of the host tissue reaction. STUDY DESIGN: A rabbit intertransverse spine fusion model was used to evaluate a bioabsorbable graft-containment implant. Study and control groups were compared with regard to the rate, volume, and quality of fusion, as well as host tissue reaction to the graft and implant. METHODS: Fourteen adult male New Zealand White rabbits underwent bilateral posterolateral intertransverse spine arthrodesis at L3-L4. The control group (n=7) received autograft alone, and the study group received autografts placed in open meshed hemicylinders fashioned from LactoSorb sheets (LactoSorb; Biomet Orthopedics Inc., Warsaw, IN). Spines were harvested at 6 weeks and imaged. Radiographs and computed tomography (CT) images were used to calculate the rate, area, and volume of fusion mass. Sections were fixed and stained with hematoxylin-eosin and Mallory trichrome for histological analysis of fusion and host tissue response. The Mann-Whitney nonparametric statistical test was used for the radiographic and CT qualitative assessments. The CT volume quantitation was analyzed using the Student t test. A p value of <.05 was used to assign statistical significance. RESULTS: The fusion rates on radiographs and CT imaging did not show a significant difference (p>.05) between the biocontainment and control groups. The volume of fusion revealed a significant increase with biocontainment (mean+/-standard error; total left+right fusion sides=2.88+/-0.30 cc) compared with controls (2.12+/-0.15 cc) (p<.05). Histology revealed no difference in the maturity or the quality of the fusion mass between the two groups. Inflammatory response around the developing fusion mass and muscle necrosis were slightly increased in the study group. The LactoSorb biocontainment material led to variable inflammatory reaction, with some areas showing little or no response and other showing an inflammatory response with fibrous connective tissue, lymphocyte infiltration, and focal foreign body giant cell reaction. CONCLUSIONS: The incidence of fusion was similar with or without a containment device for onlay bone graft. A significant increase in the volume of the fusion suggests that a biocontainment device does play a role in protecting the developing fusion mass from the mechanical effects of the paraspinal musculature. The clinical use of this device cannot be justified at this time, and further studies will determine whether this increase in fusion volume will translate into a better incidence and volume of fusion in primate and human models.
Authors: Mandi J Lopez; Kevin R McIntosh; Nakia D Spencer; Jade N Borneman; Ronald Horswell; Paul Anderson; Gang Yu; Lorrie Gaschen; Jeffrey M Gimble Journal: J Orthop Res Date: 2009-03 Impact factor: 3.494
Authors: F Salamanna; M Sartori; G Barbanti Brodano; C Griffoni; L Martini; S Boriani; M Fini Journal: Stem Cells Int Date: 2017-02-13 Impact factor: 5.443