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

Intervertebral Disc Degeneration Clinical Trial

— Intebody  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02400762
• Other study ID #: ISTO-INQU05-11-14
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: August 29, 2017
• Start date: October 2013
• Est. completion date: March 2019

Study information

• Verified date: August 2016
• Source: ISTO Technologies, Inc.
• Contact: Josiana Limones
• Phone: 314-995-6049
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	University of Southern Califirnia	Los Angeles	California
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ISTO Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Oswestry Disability Index v2.0		Baseline 3, 6, 12 months
Other	Visual Analogue Scale for leg and back pain		Baseline 3, 6, 12 months
Other	Short-Form-36		Baseline, 12 months
Other	EQ-5D		Baseline 3, 6, 12 months
Other	Post-operative bone fusion as measured by flexion/extension lumbar X-ray.		12 Months
Primary	Post-operative bone fusion as measured by lumbar CT scan Bone fusion		12 months
Secondary	Adverse Events		Continual post treatment
Secondary	Need for subsequent surgical intervention at target and/or adjacent level		Continual post treatment