WithdrawnPhase 4

Efficacy of Using Solum IV and BMC With GFC in TLIF

Stopped: Study was never initiated due to contracting issues

United States0Started 2017-09-30

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiological assessment : Fusion Status

Timeframe: 3 months post-treatment

Radiological assessment : Fusion Status

Timeframe: 6 months post-treatment

Radiological assessment : Fusion Status

Timeframe: 12 months post-treatment

Trial details

NCT IDNCT03223701

SponsorSeton Healthcare Family

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-30

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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