NCT06940453 CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System in Lumbar Degenerative Disease
| NCT ID | NCT06940453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Dublin |
| Condition | Lumbar Degenerative Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2024-06-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. This study will follow patients undergoing anterior lumbar interbody fusion (ALIF) procedure. This trial seeks to evaluate the performance of this CE-marked device, and to assess outcomes in frail and non-frail patient cohorts. The CONDUIT™ ALIF Cage System are intervertebral body fusion devices intended for use for anterior lumbar interbody fusion in skeletally mature patients. The devices are 3D printed cellular titanium implants that feature 80% porous macro-, micro- and nanostructures, are designed to mimic cortical and cancellous bone, and facilitate fusion. This pilot study hypothesizes that the use of CONDUIT ALIF Cage system to treat lumbar degenerative disc disease will achieve results comparable to historical cases using SYNFIX Systems.
Eligibility 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.
Contact & Investigator
Joseph Butler, PhD
PRINCIPAL INVESTIGATOR
Mater Misericordiae University Hospital
Frequently Asked Questions
Who can join the NCT06940453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Degenerative Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940453 currently recruiting?
Yes, NCT06940453 is actively recruiting participants. Contact the research team at jakemcdonnell@eril.ie for enrollment information.
Where is the NCT06940453 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT06940453 clinical trial?
NCT06940453 is sponsored by University College Dublin. The principal investigator is Joseph Butler, PhD at Mater Misericordiae University Hospital. The trial plans to enroll 35 participants.