CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System in Lumbar Degenerative Disease

NCT06940453 | Recruiting FDA Device

• 1 other identifier: CONDUIT™
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disease

Keywords

INTERBODY FUSION; SPINE SURGERY; LUMBAR DEGENERATION; SPINAL FUSION; SPINAL FIXATION

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Changes in Patient Reported Pain as Measured Using Visual Analogue Scale Score Throughout Follow up Period

  24 months

• Changes in Patient Reported Function as Measured Using Oswestry Disability Index Throughout Follow up Period

  24 months

• Changes in Patient Reported Function as Measured Using Short Form 12 Throughout Follow up Period

  24 months

Study Arms (1)

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.

Device: CONDUIT

Interventions

CONDUIT DEVICE

Arm 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.

SYNFIX COHORT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (\&gt;18 years old) with lumbar degenerative disease requiring surgical intervention and stabilisation with instrumentation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Dublin: lead
• Mater Misericordiae University Hospital: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Leinster, D07R2WY, Ireland

RECRUITING

Related Publications (4)

• Verla T, Xu DS, Davis MJ, Reece EM, Kelly M, Nunez M, Winocour SJ, Ropper AE. Failure in Cervical Spinal Fusion and Current Management Modalities. Semin Plast Surg. 2021 Feb;35(1):10-13. doi: 10.1055/s-0041-1722853. Epub 2021 May 10.

  PMID: 33994872 BACKGROUND

• Lau D, Chou D, Ziewacz JE, Mummaneni PV. The effects of smoking on perioperative outcomes and pseudarthrosis following anterior cervical corpectomy: Clinical article. J Neurosurg Spine. 2014 Oct;21(4):547-58. doi: 10.3171/2014.6.SPINE13762. Epub 2014 Jul 11.

  PMID: 25014499 BACKGROUND

• undefined

  BACKGROUND

• Badiee RK, Mayer R, Pennicooke B, Chou D, Mummaneni PV, Tan LA. Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies. J Spine Surg. 2020 Mar;6(1):323-333. doi: 10.21037/jss.2019.11.01.

  PMID: 32309669 BACKGROUND

MeSH Terms

Interventions

Urinary Diversion

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joseph Butler, PhD

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jake McDonnell, MRCS

CONTACT

+353852802958; jakemcdonnell@eril.ie

Joseph Butler, PhD

CONTACT

+353877034291; josephsbutler@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: April 23, 2025
• Study Start: June 28, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)