Evaluation of a new device for spinal fusion in patients with lumbar degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.