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Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery (Intebody)

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ClinicalTrials.gov Identifier: NCT02400762
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
ISTO Technologies, Inc.

Brief Summary:

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

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources




Primary Outcome Measures :
  1. Post-operative bone fusion as measured by lumbar CT scan Bone fusion [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Continual post treatment ]
  2. Need for subsequent surgical intervention at target and/or adjacent level [ Time Frame: Continual post treatment ]

Other Outcome Measures:
  1. Oswestry Disability Index v2.0 [ Time Frame: Baseline 3, 6, 12 months ]
  2. Visual Analogue Scale for leg and back pain [ Time Frame: Baseline 3, 6, 12 months ]
  3. Short-Form-36 [ Time Frame: Baseline, 12 months ]
  4. EQ-5D [ Time Frame: Baseline 3, 6, 12 months ]
  5. Post-operative bone fusion as measured by flexion/extension lumbar X-ray. [ Time Frame: 12 Months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients who have given consent for and who undergo standard-of-care single level transforaminal or posterior lumbar interbody fusion surgery in which InQu Bone Graft Extender is used on-label.
Criteria

Inclusion Criteria:

  • A subject may be included if s/he meets the following criteria:

    1. ≥18 years of age;
    2. Able to give appropriate informed consent;
    3. Willing and able to meet the proposed follow-up schedule;
    4. Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis and/or degenerative disc disease;
    5. Has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion;
    6. Use of InQu Bone Graft Extender on-label.

Exclusion Criteria:

  1. Any prior lumbar fusion surgery;
  2. Requires fusion surgery of more than two adjacent levels;
  3. Has fusion surgery requiring titanium cages;
  4. Has a systemic infection or has infection at the site of surgery;
  5. Has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing;
  6. Has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.

Information from the National Library of Medicine

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


Contacts
Contact: Josiana Limones 314-995-6049

Locations
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         
Sponsors and Collaborators
ISTO Technologies, Inc.
Investigators
Study Director: Michaela H Purcell ISTO Technologies, Inc.

Responsible Party: ISTO Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02400762     History of Changes
Other Study ID Numbers: ISTO-INQU05-11-14
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2016

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases