Recruiting

InQu® Bone Graft

Sponsor:

ISTO Technologies, Inc.

Code:

NCT02400762

Conditions

Intervertebral Disc Degeneration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Intervertebral Disc Degeneration

Study ID

NCT02400762

Start date

Oct, 2013

Status verified date

Aug, 2016

Completion date

Mar, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Post-operative bone fusion as measured by lumbar CT scan Bone fusion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Josiana Limones

314-995-6049

Locations

University of Southern Califirnia

Recruiting

Los Angeles, California, United States, 90033

Contacts

Frank Acosta, MD

800-872-2273

More Information

Sponsor

ISTO Technologies, Inc.

Last update posted

Aug 31, 2017

Last verified

Aug, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ISTO Technologies, Inc. on 2017-08-31.