Degenerative Disc Disease Clinical Trial
Official title:
Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
Verified date | April 2018 |
Source | Seton Healthcare Family |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject is skeletally mature and older than 18 years of age 2. One and contiguous 2 or 3 level primary lumbar fusions. 3. L1 to S1 with a primary diagnosis of one or more of the following: 1. Degenerative disc disease, 2. Isthmic-lytic spondylolisthesis, 3. Degenerative spondylolisthesis 4. Spinal stenosis. 4. Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive 5. Subject understand the conditions of enrollment and is willing to sign and date the informed consent form 6. Subject agrees to comply with study visits Exclusion Criteria: 1. Previous bilateral Iliac Crest Bone Graft (ICBG) harvest 2. Previous instrumented fusion at the same or adjacent level 3. Active systemic infection, infection localized to the site of implantation or at aspiration site 4. Vulnerable patients 1. Nursing home residents 2. Prisoners 3. Other institutionalized persons 4. Persons with decisional incapacity 5. Pregnant women or interested in becoming pregnant in the next 12 months 6. Subjects with certain autoimmune diseases (such as lupus) 7. Subject has progressive neuromuscular disease 8. Active hepatitis, AIDS, ARS or is HIV positive 9. Syringomyelia at any spinal levels 10. Any other condition that would interfere with the subject self-assessment of pain, function or quality of life 11. Subjects with multiple allergies 12. Subjects with any history of cancer (except for basal cell carcinoma of the skin) 13. Significant osteoporosis 14. Subject is younger than or equal to 18 years of age 15. Subjects with a BMI of 40 or greater 16. Subject has diabetes mellitus requiring daily insulin management 17. Subject has allergy to implant materials (such as titanium, titanium alloy) 18. Subject has primary or metastatic tumors involving the spine 19. Subject is participating in another investigational study for a similar purpose 20. Subject has a history of significant mental illness or mental incapacity 21. Subject is currently smoker and will not cease smoking from the time of study enrollment up through 3 months post-operatively, nicotine users for whom post-operative bone stimulation would be prescribed, or has a recent history of alcohol or other substance abuse within the past 2 years 22. Subject is receiving workers compensation 23. Absence of English language reading or writing skills |
Country | Name | City | State |
---|---|---|---|
United States | Seton Spine and Scoliosis Center | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Seton Healthcare Family | Celling Biosciences |
United States,
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. — View Citation
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. — View Citation
Hernigou P, Beaujean F. Treatment of osteonecrosis with autologous bone marrow grafting. Clin Orthop Relat Res. 2002 Dec;(405):14-23. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 3 months post-treatment | |
Primary | Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 6 months post-treatment | |
Primary | Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 12 months post-treatment | |
Secondary | Visual Analog Scale | Patient reported pain score | Pre-treatment | |
Secondary | Visual Analog Scale | Patient reported pain score | 3 months post-treatment | |
Secondary | Visual Analog Scale | Patient reported pain score | 6 months post-treatment | |
Secondary | Visual Analog Scale | Patient reported pain score | 12 months post-treatment | |
Secondary | Oswestry Disability Index | Patient reported disability score | Pre-treatment | |
Secondary | Oswestry Disability Index | Patient reported disability score | 3 months post-treatment | |
Secondary | Oswestry Disability Index | Patient reported disability score | 6 months post-treatment | |
Secondary | Oswestry Disability Index | Patient reported disability score | 12 months post-treatment |
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