Study Comparing Mesenchymal Precursor Cells and Autogenous Iliac Crest Bone Graft for Lumbar Interbody Fusion in a Randomized Controlled Phase 2 FDA Clinical Trial

2013 ◽  
Vol 13 (9) ◽  
pp. S30 ◽  
Author(s):  
Randall F. Dryer ◽  
Kenneth A. Pettine ◽  
Gary Ghiselli ◽  
Hyun W. Bae
Keyword(s):  
Clinical Trial ◽  
Bone Graft ◽  
Interbody Fusion ◽  
Iliac Crest ◽  
Iliac Crest Bone Graft ◽  
Lumbar Interbody Fusion ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Mesenchymal Precursor Cells ◽  
Mesenchymal Precursor

Iliac Crest Bone Graft for Minimally Invasive Transforaminal Lumbar Interbody Fusion

Spine ◽  
2018 ◽  
pp. 1 ◽  
Author(s):  
Brittany E. Haws ◽  
Benjamin Khechen ◽  
Ankur S. Narain ◽  
Fady Y. Hijji ◽  
Kaitlyn L. Cardinal ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Bone Graft ◽  
Interbody Fusion ◽  
Iliac Crest ◽  
Transforaminal Lumbar Interbody Fusion ◽  
Iliac Crest Bone Graft ◽  
Lumbar Interbody Fusion

Peptide Enhanced Bone Graft Substitute Presents Improved Short-Term Increase in Bone Volume and Construct Stiffness Compared to Iliac Crest Autologous Bone in an Ovine Lumbar Interbody Fusion Model

2021 ◽  
pp. 219256822097983
Author(s):  
Arjan C. Y. Loenen ◽  
Jerome Connor ◽  
Scott Johnson ◽  
Katherine Davis ◽  
Nolan Hannigan ◽  
...  
Keyword(s):  
Bone Graft ◽  
Bone Remodeling ◽  
Interbody Fusion ◽  
Iliac Crest ◽  
Bone Graft Substitute ◽  
Iliac Crest Bone Graft ◽  
Graft Material ◽  
Lumbar Interbody Fusion ◽  
Ovine Model ◽  
Systemic Health

Study design: Preclinical ovine model. Objective: To assess the in vivo efficacy and safety of the P-15 L bone graft substitute and compare its performance to autologous iliac crest bone graft (ICBG) for lumbar interbody fusion indications. Methods: Thirty skeletally mature sheep underwent lumbar interbody fusion surgery. Half of the sheep received autologous ICBG and the other half the peptide enhanced bone graft substitute (P-15 L). Following termination at 1, 3, and 6 months after surgery, the operated segments were analyzed using micro computed tomography (µCT), histology, and destructive mechanical testing. Additional systemic health monitoring was performed for the P-15 L group. Results: One month after surgery, there was only minor evidence of bone remodeling and residual graft material could be clearly observed within the cage. There was active bone remodeling between 1 and 3 months after surgery. At 3 months after surgery significantly denser and stiffer bone was found in the P-15 L group, whereas at 6 months, P-15 L and ICBG gave similar fusion results. The P-15 L bone graft substitute did not have any adverse effects on systemic health. Conclusions: The drug device combination P-15 L was demonstrated to be effective and save for lumbar interbody fusion as evidenced by this ovine model. Compared to autologous ICBG, P-15 L seems to expedite bone formation and remodeling but in the longer-term fusion results were similar.

scholarly journals Microcomputed tomographic, biomechanical and histological analyses of lumbar interbody fusion with iliac crest bone graft in a pig model

2021 ◽  
Vol 90 (1) ◽  
pp. 69-75
Author(s):  
Milan Krtička ◽  
Vladimír Nekuda ◽  
Daniel Ira ◽  
Radek Sedláček ◽  
Tomáš Suchý ◽  
...  
Keyword(s):  
Bone Graft ◽  
Interbody Fusion ◽  
Iliac Crest ◽  
Biomechanical Analysis ◽  
Iliac Crest Bone Graft ◽  
Testing System ◽  
Lumbar Interbody Fusion ◽  
Micro Ct ◽  
Histological Assessment ◽  
Load Limit

The main goal of this study was to assess the progress of vertebral stability after lumbar interbody fusion related to microcomputed tomography (micro CT), biomechanical analysis, and histological assessment towards spine fusion. Twelve male pigs were used; each underwent L2-3 discectomy and implantation of an iliac crest bone graft in two groups; six spines were harvested eight weeks (A1) and six spines 16 weeks (A2) after surgery (7 native spines for biomechanical analysis). The CT was performed by GE phoenix datos|x 2.0 with a sample drift correction. The samples were divided according to fusion quality. Biomechanical evaluation was carried out on the MTS Mini Bionix testing system. In the nondestructive mode, three cycles of pure bending moments were applied (5 Nm load limit) at a rate of 20 °/min in flexion (+40 °) and extension (-40 °). Two representative histological sections from four samples were obtained (A1, n = 2; A2, n = 2); areas of mature bone were quantified. In micro CT, better results were achieved in group A2 (not significant). Eight weeks after the operation, flexural stiffness decreased to 48% of its initial value for native cadavers (P < 0.05); after 16 weeks it was comparable to native cadavers, demonstrating the suitability of the implanted graft (P < 0.05). The newly formed bone tissue occupied an average area of 94.205 mm2 (A1) and 26.240 mm2 (A2). It was confirmed that micro CT, biomechanical analysis, and histological assessment are technically feasible and suitable for the evaluation of results of other methods of large bone defect treatment.

scholarly journals Efficacy of Platelet-rich Plasma Impregnation for Unidirectional Porous Β-tricalcium Phosphate in Lateral Lumbar Interbody Fusion: Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Kosuke Sato ◽  
Toru Funayama ◽  
Hiroshi Noguchi ◽  
Tomoyuki Asada ◽  
Mamoru Kono ◽  
...  
Keyword(s):  
Bone Graft ◽  
Spinal Fusion ◽  
Interbody Fusion ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Fusion Rate ◽  
Lumbar Interbody Fusion ◽  
Artificial Bone ◽  
Randomized Controlled ◽  
Lateral Lumbar Interbody Fusion

Abstract BackgroundPlatelet-rich plasma has been increasingly used in spinal fusion surgery. However, the efficacy of platelet-rich plasma in lateral lumbar interbody fusion is unclear. In Japan, Affinos® (Kuraray Co., Tokyo, Japan), which is a β-tricalcium phosphate artificial bone, has been increasingly used for spinal fusion as a bone graft. The purpose of this trial is to demonstrate whether Affinos® impregnated with platelet-rich plasma can achieve a higher fusion rate, more rapid fusion, and better clinical outcomes than Affinos® alone.Methods/DesignThe current study is a prospective randomized controlled trial. The current trial will include consecutive patients scheduled for lateral lumbar interbody fusion. Since an intervertebral cage for lateral lumbar interbody fusion has two spaces for a bone graft, two bone grafts are inserted for each intervertebral level. In the current study, an artificial bone with plate-rich plasma will be inserted into one space and an artificial bone without platelet-rich plasma will be inserted into the other space. We will compare the fusion rates between the bone graft with and without platelet-rich plasma. Our primary endpoint will be the interbody fusion rate at 1 year after surgery. DiscussionThe current trial will verify the efficacy of platelet-rich plasma with Affinos® for bony fusion in lateral lumbar interbody fusion. This trial will provide substantial evidence for the effectiveness and safety of platelet-rich plasma in spinal fusion surgery.Trial registrationJapan Registry of Clinical Trials (jRCT), ID: jRCTb032200199. First registered on 13 November 2020, https://jrct.niph.go.jp/latest-detail/jRCTb032200199. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

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