Efficacy of Using Solum IV and BMC With GFC in TLIF

Withdrawn before enrolling · Phase 4

Conditions studied: Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis, Degenerative Spondylolisthesis, Spinal Stenosis

In brief

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).

Key facts

Study ID

NCT03223701

Run by

Seton Healthcare Family

People needed

0

Starts

2017-09-30

Expected to finish

2018-12-30

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is skeletally mature and older than 18 years of age
• One and contiguous 2 or 3 level primary lumbar fusions.
• L1 to S1 with a primary diagnosis of one or more of the following:
• Degenerative disc disease,
• Isthmic-lytic spondylolisthesis,
• Degenerative spondylolisthesis
• Spinal stenosis.
• Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive
• Subject understand the conditions of enrollment and is willing to sign and date the informed consent form
• Subject agrees to comply with study visits

You may not qualify if…

• Previous bilateral Iliac Crest Bone Graft (ICBG) harvest
• Previous instrumented fusion at the same or adjacent level
• Active systemic infection, infection localized to the site of implantation or at aspiration site
• Vulnerable patients
• Nursing home residents
• Prisoners
• Other institutionalized persons
• Persons with decisional incapacity
• Pregnant women or interested in becoming pregnant in the next 12 months
• Subjects with certain autoimmune diseases (such as lupus)
• Subject has progressive neuromuscular disease
• Active hepatitis, AIDS, ARS or is HIV positive
• Syringomyelia at any spinal levels
• Any other condition that would interfere with the subject self-assessment of pain, function or quality of life
• Subjects with multiple allergies
• Subjects with any history of cancer (except for basal cell carcinoma of the skin)
• Significant osteoporosis
• Subject is younger than or equal to 18 years of age
• Subjects with a BMI of 40 or greater
• Subject has diabetes mellitus requiring daily insulin management
• Subject has allergy to implant materials (such as titanium, titanium alloy)
• Subject has primary or metastatic tumors involving the spine
• Subject is participating in another investigational study for a similar purpose
• Subject has a history of significant mental illness or mental incapacity
• 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

Where it is running

• Seton Spine and Scoliosis Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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