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Enrolling by invitation NCT05762055

Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

No phase Interventional Cervical Radiculopathy Cervical Myelopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Titan nanoLOCK interbody cage, ACDF interbody cage.
Who it may be relevant to
Registry conditions: Cervical Radiculopathy, Cervical Myelopathy. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

Overview

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.

Interventions

  • Device Titan nanoLOCK interbody cage
    Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
  • Device ACDF interbody cage
    Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology

Primary outcome measures

  • Number of patient reported dysphagia events measured by Eat-10 assessment tool [Time frame: Postoperative at Day 1]
  • Number of patient reported dysphagia events measured by Eat-10 assessment tool [Time frame: 2 weeks following surgery]
  • Number of patient reported dysphagia events measured by Eat-10 assessment tool [Time frame: 3 months following surgery]
  • Number of patient reported dysphagia events measured by Eat-10 assessment tool [Time frame: 6 months following surgery]
  • Number of patient reported dysphagia events measured by Eat-10 assessment tool [Time frame: 12 months following surgery]
  • Dysphagia as measured by SWAL-QOL assessment tool [Time frame: Postoperative at day 1]
  • Dysphagia as measured by SWAL-QOL assessment tool [Time frame: 2 weeks following surgery]
  • Dysphagia as measured by SWAL-QOL assessment tool [Time frame: 3 months following surgery]
  • Dysphagia as measured by SWAL-QOL assessment tool [Time frame: 6 months following surgery]
  • Dysphagia as measured by SWAL-QOL assessment tool [Time frame: 12 months following surgery]
Secondary outcome measures (12)
  • Percentage of participants experiencing neck pain [Time frame: Baseline (Pre-op)]
  • Percentage of participants experiencing neck pain [Time frame: 6 weeks following surgery]
  • Percentage of participants experiencing neck pain [Time frame: 3 months following surgery]
  • Percentage of participants experiencing neck pain [Time frame: 6 months following surgery]
  • Percentage of participants experiencing neck pain [Time frame: 12 months following surgery]
  • Percentage of participants showing functional improvement [Time frame: Baseline (Pre-op)]
  • Percentage of participants showing functional improvement [Time frame: 6 weeks following surgery]
  • Percentage of participants showing functional improvement [Time frame: 3 months following surgery]
  • Percentage of participants showing functional improvement [Time frame: 6 months following surgery]
  • Percentage of participants showing functional improvement [Time frame: 12 months following surgery]
  • Number of participants who experienced overall complications [Time frame: 3 years following surgery]
  • Percentage of participants reporting functional outcomes as measured by PROMIS-29 [Time frame: Baseline (Pre-op)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Texas Southwestern Medical Center — Dallas

Identifiers

NCT: NCT05762055 · STU-2022-1092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗