Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

Radiculopathy Clinical Trial

Official title:

Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05696470
• Other study ID #: 2020H0309
• Status: Active, not recruiting
• Start date: March 31, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this trial is to assess fusion rates in 3 and 4 level ACDFs in patients implanted with DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM. This will be a non-inferiority study, looking to show that Synthes Conduit 3D printed titanium cages fuse as well as cages.

Description:

This is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 Patients undergoing 3 to 4 level ACDF procedures from C2-T1 will be enrolled. Patients will be implanted with DePuy Conduit Titanium ACDF cage (DePuy Synthes, Raynham, MA). A retrospective comparision group will be used. The retrospective group will include 58 consecutive patients undergoing 3-4 level ACDFs with milled allograft. This single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. The inclusion/exclusion criteria are listed below.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old
• Symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between C2-T1).
• Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)
• Cervical x-rays at 24 months (±60 days; retrospective comparison group only)

Exclusion Criteria:

• Traumatic spinal fractures or spinal cord injury
• Previous cervical fusion surgery
• Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator
• Severe co-morbidities (e.g., heart, respiratory, or renal disease)
• Recent (<3 yrs) or co-incident spinal tumor or infection
• Concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only)
• History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up
• Subjects who are pregnant or plan to become pregnant in the next 24 months
• Prisoner
• Other contraindications for DePuy Conduit 3D printed titanium cage implant (prospective exclusion only)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Foraminal Stenosis
• Myelopathy Cervical
• Radiculopathy
• Spinal Cord Diseases

Intervention

Device:
• DePuy Synthes Conduit 3D printed titanium cages
DePuy Conduit 3D printed titanium cages supplemented with SKYLINE Anterior Cervical Plate System and 1 CC DBM

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center Neurological Surgery	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion rate	based on postoperative X-ray: presence of bone trabeculae across graft-host interface, absence of radiolucent gap between graft and adjacent vertebral body, restriction of motion to 2mm or less between adjacent vertebral spinous processes on flexion-extension lateral radiographs	24 months
Secondary	NRS	Numeric Rating Scale for neck and arm pain	24 months
Secondary	NDI	Neck Disability Index	24 months
Secondary	SF36 RAND	Short Form 36 RAND	24 months
Secondary	Neurological assessment: Upper Extremity Strength	grip, biceps, triceps, delts, intrinsics, wrist extrinsic) measured on scale of 0-5 follwing INSCI assessment for Manual Muscle Testing (MMT)	24 months
Secondary	Cervical sagittal alignment	Standing radiographs of the sagittal spine to identify changes in functional sagittal; will measure the Cobb angle between the lower endplate of C2 and C7 (C2L-C7L angle) alignment after cervical fusion as determined by functional segments between cervicothoracic and thoracolumbar. Patient cervical 4 view x-rays pre-operatively and at follow-ups will be compared.	24 months
Secondary	Reoperation	Reoperation at cervical and thoracic levels while patient is enrolled in the study. Hardware removed, new hardware added	24 months
Secondary	number of days in the hospital	number of days in the hospital	up to 24 months
Secondary	Adverse events	wound infection, dysphagia, hematoma, dysphonia, DVT, etc	24 months
Secondary	Neurological assessment: Sensory function (C2-C7 dermatome)	Pin prick sensation is assessed with a needle. Light touch sensation is assessed with a piece of tissue paper.	24 months
Secondary	Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2)	Reflexes (Biceps, Brachioradials, Triceps)-Upper and lower extremities should be examined for asymmetry in deep tendon reflexes.	24 months
Secondary	Neurological assessment: Hoffman's and Spurlings	Testing for positive or negative indication	24 months