Clinical trial · Interventional
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
A Prospective Multi-Center Evaluation of a Hydraulic Expandable TLIF Cage for the Treatment of Degenerative Disc Disease of the Lumbar Spine
NCT02704689CI-TRIAL-00032641APROPOSterminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of subject enrollment
Summary
Brief summary (as posted)
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, at one or two levels, between L2 and S1.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Retrolisthesis | — | UNRESOLVED | — |
| Spondylolisthesis, Grade 1 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AccuLIF expandable TLIF cage | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AccuLIF
- interventionNames
- Device: AccuLIF expandable TLIF cage
Primary outcomes (2)
- measure
- Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.
- timeFrame
- 24 months
- description
- Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.
- measure
- Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.
- timeFrame
- 24 months
- description
- Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is skeletally mature and between 18 and 70 years of age. 2. DDD and up to Grade I spondylolisthesis or retrolisthesis, requiring decompression and arthrodesis at one or two contiguous levels between L2 and S1. 3. No previous surgery at the same or adjacent level (other than microdiscectomy / laminectomy) at the same or adjacent level. 4. Non-responsive to conservative (non-surgical) treatment for back pain for a minimum of 6 months. 5. Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent. 6. Subject agrees to comply with visit schedule and completing study questionnaires. Exclusion Criteria: 1. Significant instability of the spine. 2. Requires TLIF at more than 2 levels between L2 and S1. 3. Previously undergone lumbar spine surgery (other than microdiscectomy / laminectomy) at the same or adjacent level. 4. Younger than 18 years of age, or older than 70 years of age. 5. BMI of 40 or greater. 6. History of metabolic bone disease 7. Osteoporosis 8. Diabetes mellitus requiring daily insulin management. 9. Subject has any of the following: 1. Progressive neuromuscular disease; OR 2. Autoimmune disease; OR 3. Active malignancy within the last 15 years; OR 4. Active hepatitis; OR 5. AIDS, ARC, or is HIV positive; OR 6. Syringomyelia at any spinal level; OR 7. Any other condition that would interfere with the subject self -assessment of pain, function or quality of life. 10. Allergy to implant materials (titanium, titanium alloy). 11. Active systemic infection or infection localized to the site of implantation. 12. Primary or metastatic tumors involving the spine. 13. Open wounds or inadequate issue tissue coverage over the operative site. 14. History of significant mental illness or mental incapacity. 15. Pregnancy or intent to become pregnant. 16. Participating in another investigational study for a similar purpose. 17. Belongs to a vulnerable population that would compromise ability to provide informed consent or compliance with follow-up requirements. 18. Smokers unwilling to cease up to 3 months post-op or recent history of alcohol or other substance abuse within the past 2 years. 19. Workers compensation.
References
Publications (0)
Data not yet available
No reference posted for this study.