drugset / Trial / NCT03223701
Efficacy of Using Solum IV and BMC With GFC in TLIF
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the efficacy of using Solum IV and bone marrow concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).
Timeline
- Start
- 2017-09-30
- Primary completion
- 2018-09-30
- Completion
- 2018-12-30
Publications
- Background Hernigou P, Beaujean F. Treatment of osteonecrosis with autologous bone marrow grafting. Clin Orthop Relat Res. 2002 Dec;(405):14-23. doi: 10.1097/00003086-200212000-00003.
- Background Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18.
- Background Galois L, Bensoussan D, Diligent J, Pinzano A, Henrionnet C, Choufani E, Stoltz JF, Mainard D. Autologous bone marrow graft and treatment of delayed and non-unions of long bones: technical aspects. Biomed Mater Eng. 2009;19(4-5):277-81. doi: 10.3233/BME-2009-0592.
- Background Johnson RG. Bone marrow concentrate with allograft equivalent to autograft in lumbar fusions. Spine (Phila Pa 1976). 2014 Apr 20;39(9):695-700. doi: 10.1097/BRS.0000000000000254.
- Results Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bone Marrow Concentrate | Cell therapy | — | Other |
| Subject | Solum IV | Unknown | — | Other |
| Subject | general fluid concentrate | Unknown | — | Other |