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

• Conditions: Intervertebral Disc Degeneration

• Registration Number: NCT02400762
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Status Verified: 2016-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-31
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative bone fusion as measured by lumbar CT scan Bone fusion	12 months

Secondary Outcome Measures

Name	Time	Method
Need for subsequent surgical intervention at target and/or adjacent level	Continual post treatment
Adverse Events	Continual post treatment

Trial Locations

Locations (2)

University of Southern Califirnia; 🇺🇸 Los Angeles, California, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States