Evaluation of lumbar spinal fusion utilizing recombinant human platelet derived growth factor‐B chain homodimer (rhPDGF‐BB) combined with a bovine collagen/β‐tricalcium phosphate (β‐TCP) matrix in an ovine model

Abstract

Background context While the clinical effectiveness of recombinant human Platelet Derived Growth Factor‐B chain homodimer combined with collagen and β‐tricalcium phosphate (rhPDGF‐BB + collagen/β‐TCP) treatment for indications involving hindfoot and ankle is well‐established, it is not approved for use in spinal interbody fusion, and the use of autograft remains the gold standard. Purpose The purpose of this study was to compare the effects of rhPDGF‐BB + collagen/β‐TCP treatment on lumbar spine interbody fusion in an ovine model to those of autograft bone and collagen/β‐TCP treatments using biomechanical, radiographic, and histological assessment techniques. Study design Thirty‐two skeletally mature Columbian Rambouillet sheep were used to evaluate the safety and effectiveness of rhPDGF‐BB + collagen/β‐TCP matrix in a lumbar spinal fusion model. Interbody polyetheretherketone (PEEK) cages contained either autograft, rhPDGF‐BB + collagen/β‐TCP, collagen/β‐TCP matrix, or left empty. Methods Animals were sacrificed 8‐ or 16‐weeks post‐surgery. Spinal fusion was evaluated via post‐sacrifice biomechanical, micro‐computed tomography (μCT), and histological analysis. Outcomes were statistically compared using a two‐way analysis of variance (ANOVA) with an alpha value of 0.05 and a Tukey post‐hoc test. Results There were no statistically significant differences between groups within treatment timepoints for flexion‐extension, lateral bending, or axial rotation range of motion, neutral zone, neutral zone stiffness, or elastic zone stiffness. μCT bone volume fraction was significantly greater between treatment groups independent of timepoint where Autograft and rhPDGF‐BB + collagen/β‐TCP treatments demonstrated significantly greater bone volume fraction as compared to collagen/β‐TCP (P = .026 and P = .038, respectively) and Empty cage treatments (P = .002 and P = .003, respectively). μCT mean bone density fraction was most improved in rhPDGF‐BB + collagen/β‐TCP specimens at the 8 week and 16‐week timepoints as compared to all other treatment groups. There were no statistically significant differences in histomorphometric measurements of bone, soft tissue, or empty space between rhPDGF‐BB + collagen/β‐TCP and autograft treatments. Conclusions The results of this study indicate that the use of rhPDGF‐BB combined with collagen/β‐TCP promotes spinal fusion comparable to that of autograft bone. Clinical significance The data indicate that rhPDGF‐BB combined with collagen/β‐TCP promotes spinal fusion comparably to autograft bone treatment and may offer a viable alternative in large animal spinal fusion. Future prospective clinical studies are necessary to fully understand the role of rhPDGF‐BB combined with collagen/β‐TCP in human spinal fusion healing.

Novel 3D printed lattice structure titanium cages evaluated in an ovine model of interbody fusion

“…Additionally, the titanium cage design groups exhibited improved bone volume fraction as compared to the Empty PEEK group. The histomorphometry analysis also revealed improved fusion outcomes in the titanium cage groups as compared to the PEEK cage groups, with increased percent bone area and decreased empty area 11 . When taken together, these data illustrate the superior boney integration of additively manufactured porous titanium interbody cages as compared to solid PEEK interbody cages.…”

“…While significant differences in outcome parameters between titanium cage design groups were not found, qualitative comparisons with a previously published study that utilized PEEK cages highlight the difference of fusion quality between these two cage materials. Specifically, the nondestructive biomechanical testing data revealed greatly improved fusion performance in the lateral bending and flexion/extension directions of both titanium cage groups as compared to the PEEK cage with or without Autograft samples from a previous study 11 . The microCT analysis revealed improved bone mineral density in the titanium cage design groups as compared to both PEEK groups 11 .…”

An Update on the Clinical Efficacy and Safety of Collagen Injectables for Aesthetic and Regenerative Medicine Applications

“…In addition to the strict regulation to which all implantable products are subjected, two consecutive negative patient skin tests at 6 and 2 weeks are required before use [ 73 , 74 ]. This sensitivity has been considered generally acceptable for implants for human use and actually bovine collagen is principally used for the treatment of the integumental [ 6 , 75 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 ] (NCT01060943) and musculoskeletal apparatus [ 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 ] and to a minor extent for the gastrointestinal [ 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 ], urinary [ 65 , …”

“…Collagen-based formulations are mainly used for the treatment of several kind of diseases belonging mainly to the musculoskeletal (i.e., hip or knee osteoarthritis [ 112 , 131 , 133 , 140 , 142 , 144 , 182 ], sprained knee pain [ 143 ], injured cartilage [ 138 , 141 ], piriformis syndrome [ 136 ], ankle and hindfoot arthritis [ 103 ] or fusion [ 100 , 106 , 107 , 108 , 109 ], lumbar spinal fusion [ 99 ], myofascial pain syndrome [ 130 , 137 ], chronic pain [ 132 ], acute lumbar spine pain [ 134 ], partial-thickness rotator cuff tears [ 141 , 146 , 183 ], plantar fasciitis [ 184 ], calcific supraspinatus tendinitis [ 145 ], pain [ 130 , 132 , 134 , 137 ]), urogenital (i.e., urinary incontinence [ 122 , 124 , 125 , 185 , 186 , 187 , 188 , 189 ], neurogenic urinary incontinence [ 190 ], lichens sclerosus [ 165 ], intrinsic sphincter deficiency [ 191 , 192 , 193 ], post-prostatectomy incontinence [ 65 , 123 , 194 ,…”

“…Thus, musculoskeletal apparatus-related medical treatments and costs increase with population age (numbers over 50 years). Among invasive and non-invasive currently available treatments, collagen injections are revealed to be quite effective for the treatment of several musculoskeletal diseases such as hip [ 131 ] or knee osteoarthritis [ 112 , 133 , 140 , 142 , 144 , 182 ], sprained knee pain [ 143 ], injured cartilage [ 138 , 141 ], piriformis syndrome [ 134 ], ankle and hindfoot arthritis [ 103 ] or fusion [ 100 , 106 , 107 , 108 , 109 ], lumbar spinal fusion [ 99 ], myofascial pain syndrome [ 130 , 137 ], chronic pain [ 132 ], acute lumbar spine pain [ 134 ] and in partial-thickness rotator cuff tears [ 141 , 144 , 183 ], plantar fasciitis [ 184 ], and calcific supraspinatus tendinitis [ 145 ] and pain [ 130 , 132 , 134 , 137 ].…”