N/A
N=102
Spineology Clinical Outcomes Trial: An IDE Investigation
Lumbar Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT02347410 ↗Enrolled (actual)
102
Serious AEs
11.8%
Results posted
Oct 2021
Primary outcome: Primary: Overall Success — 71 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SIFS graft containment device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Spineology, Inc
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Success |
71 | — |
Summary
This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.
Eligibility Criteria
Inclusion Criteria
- Skeletally mature;
- Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
- Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
- Minimum Oswestry Disability Index (ODI) score of 40;
- Received at least 6-months of conservative care; and
- Willing and able to comply with protocol evaluations and provide informed consent.
Exclusion Criteria
- Previous fusion or total disc replacement at the index level;
- Greater than Grade I spondylolisthesis;
- Has symptomatic multi-level lumbar DDD;
- Active systemic infection or infection at the local surgical site;
- Active or suspected malignancy;
- Body Mass Index of greater than or equal to 40;
- Significant metabolic bone disease;
- Taking medication known to interfere with bone healing;
- Has a current substance abuse disorder;
- Has a somatoform, dissociative, eating or psychotic disorder;
- Waddell Signs of inorganic behavior;
- Current tobacco user;
- Is a prisoner;
- If female, pregnant or contemplating pregnancy during follow-up period; or
- Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation
Data sourced from ClinicalTrials.gov (NCT02347410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.