Clinical trial NCT05762055: Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
Official title: Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Radiculopathy
Cervical Myelopathy
Keywords: spine
cervical
discectomy
bony fusion
dysphagia
radiographic fusion
radiographic adjacent segment disease
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2023-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. Eligible patients undergoing ACDF (see inclusion criteria listed below) will be randomized to an Intervention or Control Group, which will differ according to the interbody cage used during the procedure. In the Intervention Group (100 patients), Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted at each treated level. In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. Interbody cages used in the Control Group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. There will be no blinding to the type of implant used. Standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). Clinical and radiographic outcomes in the Intervention and Control Groups will be directly compared.

Detailed description: Aim 1: Examine the effect of nanoLOCK technology on rates of postoperative dysphagia after ACDF.

Aim 2: Evaluate the effect of nanoLOCK technology on radiographic fusion.

Aim 3: Evaluate how nanoLOCK technology influences the development of radiographic adjacent segment disease.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older
* Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels)
* Subjects with no prior history of cervical spine surgery
* Subjects with complete/usable data

Exclusion Criteria:

* Subjects under the age of 18
* Subjects not undergoing ACDF surgery
* Subjects with prior cervical spine surgery
* Subjects with cervical neoplastic or infectious disease pathology
* Subjects with cervical trauma pathology
* ACDF performed at C2-3
* Subjects with incomplete/unusable data

Primary outcomes:
measure: Number of patient reported dysphagia events measured by Eat-10 assessment tool
timeFrame: Postoperative at Day 1
measure: Number of patient reported dysphagia events measured by Eat-10 assessment tool
timeFrame: 2 weeks following surgery
measure: Number of patient reported dysphagia events measured by Eat-10 assessment tool
timeFrame: 3 months following surgery
measure: Number of patient reported dysphagia events measured by Eat-10 assessment tool
timeFrame: 6 months following surgery
measure: Number of patient reported dysphagia events measured by Eat-10 assessment tool
timeFrame: 12 months following surgery
measure: Dysphagia as measured by SWAL-QOL assessment tool
timeFrame: Postoperative at day 1
measure: Dysphagia as measured by SWAL-QOL assessment tool
timeFrame: 2 weeks following surgery
measure: Dysphagia as measured by SWAL-QOL assessment tool
timeFrame: 3 months following surgery
measure: Dysphagia as measured by SWAL-QOL assessment tool
timeFrame: 6 months following surgery
measure: Dysphagia as measured by SWAL-QOL assessment tool
timeFrame: 12 months following surgery
measure: Degree of radiographic fusion
timeFrame: 6 weeks following surgery
measure: Degree of radiographic fusion
timeFrame: 3 months following surgery
measure: Degree of radiographic fusion
timeFrame: 6 months following surgery
measure: Degree of radiographic fusion
timeFrame: 12 months following surgery
measure: Incidence of radiographic adjacent segment disease
timeFrame: 6 months following surgery
measure: Incidence of radiographic adjacent segment disease
timeFrame: 12 months following surgery
Secondary outcomes:
measure: Percentage of participants experiencing neck pain
timeFrame: Baseline (Pre-op)
measure: Percentage of participants experiencing neck pain
timeFrame: 6 weeks following surgery
measure: Percentage of participants experiencing neck pain
timeFrame: 3 months following surgery
measure: Percentage of participants experiencing neck pain
timeFrame: 6 months following surgery
measure: Percentage of participants experiencing neck pain
timeFrame: 12 months following surgery
measure: Percentage of participants showing functional improvement
timeFrame: Baseline (Pre-op)
measure: Percentage of participants showing functional improvement
timeFrame: 6 weeks following surgery
measure: Percentage of participants showing functional improvement
timeFrame: 3 months following surgery
measure: Percentage of participants showing functional improvement
timeFrame: 6 months following surgery
measure: Percentage of participants showing functional improvement
timeFrame: 12 months following surgery
measure: Number of participants who experienced overall complications
timeFrame: 3 years following surgery
measure: Percentage of participants reporting functional outcomes as measured by PROMIS-29
timeFrame: Baseline (Pre-op)
measure: Percentage of participants reporting functional outcomes as measured by PROMIS-29
timeFrame: 6 weeks following surgery
measure: Percentage of participants reporting functional outcomes as measured by PROMIS-29
timeFrame: 3 months following surgery
measure: Percentage of participants reporting functional outcomes as measured by PROMIS-29
timeFrame: 6 months following surgery
measure: Percentage of participants reporting functional outcomes as measured by PROMIS-29
timeFrame: 12 months following surgery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Salah Aoun, MD
role: PRINCIPAL_INVESTIGATOR
References: