Intervertebral Disc Degeneration
Conditions
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.
Interventions
None listed
Sponsors
ISTO Technologies, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative bone fusion as measured by lumbar CT scan Bone fusion | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events | Continual post treatment |
| Need for subsequent surgical intervention at target and/or adjacent level | Continual post treatment |
Other
| Measure | Time frame |
|---|---|
| EQ-5D | Baseline 3, 6, 12 months |
| Oswestry Disability Index v2.0 | Baseline 3, 6, 12 months |
| Post-operative bone fusion as measured by flexion/extension lumbar X-ray. | 12 Months |
| Visual Analogue Scale for leg and back pain | Baseline 3, 6, 12 months |
| Short-Form-36 | Baseline, 12 months |
Countries
United States
Contacts
Primary ContactJosiana Limones
Outcome results
None listed