Evaluation of a new device for spinal fusion in patients with lumbar degeneration
Clinical/Radiological Outcomes Associated With CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System With Supplemental Fixation for Treatment of Lumbar Degenerative Disc Disease at One or Two Contiguous Spinal Levels From L2-S1
University College Dublin · NCT06940453
This study is testing a new 3D printed titanium device for spinal fusion in patients with lower back problems to see how well it works compared to older options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College Dublin (other) |
| Locations | 1 site (Dublin, Leinster) |
| Trial ID | NCT06940453 on ClinicalTrials.gov |
What this trial studies
This observational study will follow patients undergoing anterior lumbar interbody fusion (ALIF) using the CONDUIT™ ALIF Cage System at a National Tertiary Referral Centre. The study aims to evaluate the performance of this CE-marked device, which is a 3D printed titanium implant designed to facilitate spinal fusion. It will assess outcomes in both frail and non-frail patient cohorts, comparing results to historical cases using SYNFIX Systems. The study will include patients aged 18 and older who are appropriate candidates for the ALIF procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing anterior lumbar interbody fusion and are suitable for the CONDUIT cage system.
Not a fit: Patients under 18, those with contraindications to surgery, or those with established osteoporosis or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes for patients with lumbar degenerative disease by providing a more effective spinal fusion device.
How similar studies have performed: Other studies have shown success with similar spinal fusion devices, but the specific use of the CONDUIT™ ALIF Cage System is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥ 18 years old * Consenting patients undergoing anterior lumbar interbody fusion (ALIF) procedure whom the Conduit cage system is appropriate will be included in this study. Exclusion Criteria: * Patients under 18 years of age * Non-surgical candidates, patients with contraindications to surgery (e.g. medical comorbidities, known infection, pregnancy etc.), * Patients with established osteoporosis * Long-term, systemic steroid use * Systemic diseases (e.g. rheumatoid arthritis, AIDS, HIV, etc.), * Patients unwilling or unable to give informed consent, or patients unwilling or unable to complete Health-related quality of (HRQOL) outcome life measures at the specified study time points pre- and post-operatively. * Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
Where this trial is running
Dublin, Leinster
- Mater Misericordiae University Hospital — Dublin, Leinster, Ireland (RECRUITING)
Study contacts
- Principal investigator: Joseph Butler, PhD — Mater Misericordiae University Hospital
- Study coordinator: Jake McDonnell, MRCS
- Email: jakemcdonnell@eril.ie
- Phone: +353852802958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Degenerative Disease, INTERBODY FUSION, SPINE SURGERY, LUMBAR DEGENERATION, SPINAL FUSION, SPINAL FIXATION