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

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

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).

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern Califirnia
      • Contact: Frank Acosta, MD; Phone Number: 800-872-2273
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Not yet recruiting
      • William Beaumont Hospital
      • Contact: Jeffrey Fischgrund, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative bone fusion as measured by lumbar CT scan Bone fusion	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events	Continual post treatment
Need for subsequent surgical intervention at target and/or adjacent level	Continual post treatment

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: ISTO Technologies, Inc.
• Investigators: Study Director: Michaela H Purcell, ISTO Technologies, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: ISTO-INQU05-11-14