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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Contact Information
Primary
Jake McDonnell, MRCS
jakemcdonnell@eril.ie
+353852802958
Backup
Joseph Butler, PhD
josephsbutler@gmail.com
+353877034291
Time Frame
Start Date: 2024-06-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 35
Treatments
SYNFIX COHORT
This cohort will be composed of historical, retrospective data (70 patients total) of patients who underwent surgical stabilisation for lumbar degenerative disease using the SYNFIX system, with supplemental posterior fixation.
Related Therapeutic Areas
Sponsors
Leads: University College Dublin
Collaborators: Mater Misericordiae University Hospital

This content was sourced from clinicaltrials.gov