Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
Status unconfirmed
Conditions studied: Intervertebral Disc Degeneration
In brief
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). It is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in patients who undergo PLIF or TLIF surgery. The results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).
Key facts
- Study ID
- NCT02400762
- Run by
- ISTO Technologies, Inc.
- People needed
- 130
- Starts
- 2013-10-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2017-08-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A subject may be included if s/he meets the following criteria:
- ≥18 years of age;
- Able to give appropriate informed consent;
- Willing and able to meet the proposed follow-up schedule;
- Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis and/or degenerative disc disease;
- Has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion;
- Use of InQu Bone Graft Extender on-label.
You may not qualify if…
- Any prior lumbar fusion surgery;
- Requires fusion surgery of more than two adjacent levels;
- Has fusion surgery requiring titanium cages;
- Has a systemic infection or has infection at the site of surgery;
- Has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing;
- Has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.
Where it is running
- University of Southern Califirnia — Los Angeles, California, United States (enrolling)
- William Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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