Intervertebral Disc DegenerationIntebodyNCT02400762
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
An observational study of Intervertebral Disc Degeneration, run by ISTO Technologies, Inc. at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Josiana Limones contact
United States2 sites, 2 recruiting
- Recruiting
University of Southern Califirnia
Los Angeles, California, 90033
Frank Acosta, MD, 800-872-2273
- Not yet recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Jeffrey Fischgrund, MD
About this study
Official title: 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).
Read the 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
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative bone fusion as measured by lumbar CT scan Bone fusion
Measured: 12 months
Secondary outcomes (2)
Adverse Events
Measured: Continual post treatment
Need for subsequent surgical intervention at target and/or adjacent level
Measured: Continual post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISTO Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michaela H Purcell, Study director, ISTO Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400762
- Sponsor's protocol ID
- ISTO-INQU05-11-14
- Acronym
- Intebody
- Status last verified
- Aug 2016
- First submitted
- 16 Mar 2015
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Safety and Efficacy of InQu® Bone Graft Extender in Transforaminal and Posterior Lumbar Interbody Fusion Surgery
- ClinicalTrials.gov ID
- NCT02400762
- Acronym / sponsor ID
- Intebody / ISTO-INQU05-11-14
- Conditions
- Intervertebral Disc Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ISTO Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- A subject may be included if s/he meets the following criteria:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative bone fusion as measured by lumbar CT scan Bone fusion
Time frame: 12 months
2 secondary outcomes
Adverse Events
Time frame: Continual post treatment
Need for subsequent surgical intervention at target and/or adjacent level
Time frame: Continual post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josiana Limones contact
Michaela H Purcell study director
ISTO Technologies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by ISTO Technologies, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josiana Limones (314-995-6049), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative bone fusion as measured by lumbar CT scan Bone fusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.