Clinical trial NCT02400762: Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
Official title: A Prospective Study of the Safety and Efficacy of InQu® Bone Graft Extender in Transforaminal and Posterior Lumbar Interbody Fusion Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intervertebral Disc Degeneration
Lead sponsor: ISTO Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative bone fusion as measured by lumbar CT scan Bone fusion
timeFrame: 12 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Continual post treatment
measure: Need for subsequent surgical intervention at target and/or adjacent level
timeFrame: Continual post treatment
Other outcomes:
measure: Oswestry Disability Index v2.0
timeFrame: Baseline 3, 6, 12 months
measure: Visual Analogue Scale for leg and back pain
timeFrame: Baseline 3, 6, 12 months
measure: Short-Form-36
timeFrame: Baseline, 12 months
measure: EQ-5D
timeFrame: Baseline 3, 6, 12 months
measure: Post-operative bone fusion as measured by flexion/extension lumbar X-ray.
timeFrame: 12 Months
Locations:
city: Los Angeles
country: United States
facility: University of Southern Califirnia
state: California
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: ISTO Technologies, Inc.
name: Michaela H Purcell
role: STUDY_DIRECTOR
References: