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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Post-operative bone fusion as measured by lumbar CT scan Bone fusion | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Continual post treatment | |
| Need for subsequent surgical intervention at target and/or adjacent level | Continual post treatment |
| Measure | Description | 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 |
Inclusion Criteria:
A subject may be included if s/he meets the following criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josiana Limones | Contact | 314-995-6049 |
| Name | Affiliation | Role |
|---|---|---|
| Michaela H Purcell | ISTO Technologies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern Califirnia | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Baseline, 12 months |
| EQ-5D | Baseline 3, 6, 12 months |
| Post-operative bone fusion as measured by flexion/extension lumbar X-ray. | 12 Months |
| William Beaumont Hospital | Not yet recruiting | Royal Oak | Michigan | 48073 | United States |
|