Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery (Intebody)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02400762|
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : August 31, 2017
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).
|Condition or disease|
|Intervertebral Disc Degeneration|
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) at multiple clinical sites.
Adverse events, time to fusion and Patient Reported Outcomes(PROs) will be recorded through 12 months follow-up.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||A Prospective Study of the Safety and Efficacy of InQu® Bone Graft Extender in Transforaminal and Posterior Lumbar Interbody Fusion Surgery|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
- Post-operative bone fusion as measured by lumbar CT scan Bone fusion [ Time Frame: 12 months ]
- Adverse Events [ Time Frame: Continual post treatment ]
- Need for subsequent surgical intervention at target and/or adjacent level [ Time Frame: Continual post treatment ]
- Oswestry Disability Index v2.0 [ Time Frame: Baseline 3, 6, 12 months ]
- Visual Analogue Scale for leg and back pain [ Time Frame: Baseline 3, 6, 12 months ]
- Short-Form-36 [ Time Frame: Baseline, 12 months ]
- EQ-5D [ Time Frame: Baseline 3, 6, 12 months ]
- Post-operative bone fusion as measured by flexion/extension lumbar X-ray. [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400762
|Contact: Josiana Limones||314-995-6049|
|United States, California|
|University of Southern Califirnia||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Frank Acosta, MD 800-872-2273|
|United States, Michigan|
|William Beaumont Hospital||Not yet recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Jeffrey Fischgrund, MD|
|Study Director:||Michaela H Purcell||ISTO Technologies, Inc.|