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

NCT ID: NCT02400762

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-03-31

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).

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.

Conditions

Intervertebral Disc Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISTO Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michaela H Purcell

Role: STUDY_DIRECTOR

ISTO Technologies, Inc.

Locations

University of Southern Califirnia

Los Angeles, California, United States

Site Status: RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Josiana Limones

Role: CONTACT

314-995-6049

Facility Contacts

Frank Acosta, MD

Role: primary

800-872-2273

Jeffrey Fischgrund, MD

Role: primary

Other Identifiers

ISTO-INQU05-11-14

Identifier Type: -

Identifier Source: org_study_id