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

NCT02400762 | Unknown

• 1 other identifier: ISTO-INQU05-11-14
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Post-operative bone fusion as measured by lumbar CT scan Bone fusion

  12 months

Secondary Outcomes (2)

• Adverse Events

  Continual post treatment

• Need for subsequent surgical intervention at target and/or adjacent level

  Continual post treatment

Other Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A subject may be included if s/he meets the following criteria:
• ≥18 years of age;
• Able to give appropriate informed consent;
• Willing and able to meet the proposed follow-up schedule;
• Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis and/or degenerative disc disease;
• Has given appropriate consent for, and undergoes, standard-of-care transforminal or posterior lumber interbody fusion;
• Use of InQu Bone Graft Extender on-label.

You may not qualify if:

• Any prior lumbar fusion surgery;
• Requires fusion surgery of more than two adjacent levels;
• Has fusion surgery requiring titanium cages;
• Has a systemic infection or has infection at the site of surgery;
• Has a medical condition or requires post-operative medication that, in the opinion of the investigator, may interfere with bony/soft tissue healing;
• Has any physical, social, psychological or economic condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.

Sponsors & Collaborators

• ISTO Technologies, Inc.: lead

Study Sites (2)

University of Southern Califirnia

Los Angeles, California, 90033, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michaela H Purcell

  ISTO Technologies, Inc.

  STUDY DIRECTOR

Central Study Contacts

Josiana Limones

CONTACT

314-995-6049

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 27, 2015
• Study Start: October 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 31, 2017

Record last verified: 2016-08

Locations

US (2)