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.
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.
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
Adult patients (\>18 years old) with lumbar degenerative disease requiring surgical intervention and stabilisation with instrumentation
Cohort
Other
CONDUIT
DeviceArm Description: Group/Cohort Description: This cohort is composed of patients who will be prospectively enrolled (35 total). These patients will undergo spinal stabilisation for lumbar degenerative disease using the CONDUIT ALIF cage system with supplemental posterior fixation. This device is FDA approved thus this is post market observational intervention.
Radiographic Fusion at 24 months as inferred by Presence of Segmental Stability and Absence of Mechanical Failure on Xray/CT
The primary objective of this study is to evaluate the radiographic assessment of fusion at 24 months postoperatively. This radiographic assessment will consist of plain Xrays preoperatively, at 6 weeks, 3 months, 6 months and 24 months postoperatively. These will include a combination of anterior, lateral, flexion and extension views images of lumbar spine used to infer stability. Fusion failure (pseudarthrosis) will be defined as signs of mechanical failure (such as peri-implant radiolucency/haloing, screw/rod fracture, etc.) or \<50% bridging trabecular bone on CT scan at 12 months postoperatively. Assessment of fusion will be conducted by a musculoskeletal radiologist and 2 independent fellowship trained spine surgeons.
Changes in Patient Reported Pain as Measured Using Visual Analogue Scale Score Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient pain will be recorded using the Visual Analogue Scale which ranges from 0 to 10 with a score of 10 indicating the most severe possible pain and a score of 0 indicating no pain is present. A secondary objective of this study is to prospectively gather patient reported outcomes (PROMs) in terms of pain and function
Changes in Patient Reported Function as Measured Using Oswestry Disability Index Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient function will be recorded using the Oswestry Disability Index which ranges from 0 to 100 disability with a score of 100% indicating complete disability rendering a patient bed bound and a score of 0% indicating minimal disability is present.
Changes in Patient Reported Function as Measured Using Short Form 12 Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient function will be recorded using the Short Form 12 which returns component scores representing both physical and mental status. These scores are adjusted and compare versus averages within the United States population. Both scores have an average score of 50 with a standard deviation of 10. Lower scores indicate worse function while higher scores indicate greater function.
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University College Dublin
Lead sponsor
Mater Misericordiae University Hospital
Collaborator
