Clinical trial NCT05696470: Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Official title: Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Radiculopathy
Myelopathy Cervical
Foraminal Stenosis
Central Canal Stenosis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing 3 to 4 level ACDF procedures from C2-T1

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fusion rate
timeFrame: 24 months
Secondary outcomes:
measure: NRS
timeFrame: 24 months
measure: NDI
timeFrame: 24 months
measure: SF36 RAND
timeFrame: 24 months
measure: Neurological assessment: Upper Extremity Strength
timeFrame: 24 months
measure: Cervical sagittal alignment
timeFrame: 24 months
measure: Reoperation
timeFrame: 24 months
measure: number of days in the hospital
timeFrame: up to 24 months
measure: Adverse events
timeFrame: 24 months
measure: Neurological assessment: Sensory function (C2-C7 dermatome)
timeFrame: 24 months
measure: Neurological assessment: Sensation is scored as absent (0), abnormal (1), or normal (2)
timeFrame: 24 months
measure: Neurological assessment: Hoffman's and Spurlings
timeFrame: 24 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center Neurological Surgery
state: Ohio
Study officials:
References: