Interbody Cages for Cervical Myelopathy

Overseen By Kristen Hall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Cervical neoplastic, infectious, trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ACDF interbody cage, Titan nanoLOCK interbody cage for cervical myelopathy?

Research shows that using interbody cages, like titanium or tantalum cages, in anterior cervical discectomy and fusion (ACDF) surgeries can lead to significant improvements in neck and arm pain, as well as overall patient satisfaction. These cages help in achieving good fusion rates and are considered effective for treating conditions like cervical myelopathy. ^{1 2 3 4 5}

Is the use of interbody cages for cervical myelopathy generally safe?

Studies show that interbody cages, like tantalum and carbon fiber cages, used in cervical spine surgeries are generally safe, with improvements in pain and disability reported. There are some risks, such as nonfusion, but these are not common. ^{1 3 5 6 7}

How does the Titan nanoLOCK interbody cage treatment differ from other treatments for cervical myelopathy?

The Titan nanoLOCK interbody cage is unique because it uses advanced materials that mimic the properties of natural bone, which can enhance bone growth and simplify the fusion process. Unlike traditional methods that may require bone grafts, this cage offers a stand-alone solution, potentially reducing the need for additional procedures. ^{1 3 4 5 8}

What is the purpose of this trial?

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.

Research Team

Salah Aoun, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults 18+ who need ACDF surgery due to degenerative issues in one, two, or three levels of their cervical spine and haven't had previous neck surgeries. Participants must also have complete data that can be used for the study.

Inclusion Criteria

I have never had surgery on my neck.

I am having neck surgery for degeneration affecting up to three spinal levels.

Participants with all the necessary and understandable information.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ACDF surgery with either nanoLOCK technology or an alternative interbody cage system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of dysphagia, radiographic fusion, and adjacent segment disease

12 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for long-term complications and outcomes, including neck pain and overall complications

3 years

Treatment Details

Interventions

• ACDF interbody cage
• Titan nanoLOCK interbody cage

Trial Overview The study compares two types of interbody cages used in ACDF surgery: Titan nanoLOCK cage with osseointegrative technology versus a standard cage without this technology. It's randomized with no blinding, involving 200 patients split into two groups.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group

Group II: Control Group Experimental Treatment 1 Intervention

Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

The bridge-type zero-profile anchored spacer (ROI-C) showed significant advantages over anterior cervical discectomy and fusion (ACDF) in terms of shorter surgical duration (101 min vs. 118 min) and less blood loss (102 ml vs. 145 ml), indicating a potentially safer and more efficient surgical option for cervical spondylotic myelopathy.

Both surgical methods resulted in significant improvements in patient outcomes, but the ROI-C group had a lower incidence of postoperative dysphagia compared to the ACDF group, suggesting that ROI-C may lead to fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Bridge-Type Zero-Profile Anchored Spacer (ROI-C) Interbody Fusion Cage System and Anterior Cervical Discectomy and Fusion (ACDF) with Plating and Cage System in Cervical Spondylotic Myelopathy. He, S., Zhou, Z., Shao, X., et al.[2022]

The ROI-C interbody fusion cage system is safe and effective for treating cervical spondylosis in patients with osteoporosis, showing significant improvements in clinical outcomes like JOA and NDI scores after surgery.

Postoperative radiographic parameters, including cervical curvature and intervertebral height, were significantly improved and maintained over a follow-up period of approximately 27 months, with only mild dysphagia reported in two patients that resolved quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. Rong, Y., Luo, Y., Liu, W., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Comparing the Bridge-Type Zero-Profile Anchored Spacer (ROI-C) Interbody Fusion Cage System and Anterior Cervical Discectomy and Fusion (ACDF) with Plating and Cage System in Cervical Spondylotic Myelopathy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of 2-Level Versus 3- or 4-Level Anterior Cervical Discectomy and Fusion Using a Biomimetic Surface Titanium Cage: Multicenter Experience. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical effects of the bridge-type ROI-C interbody fusion cage system in the treatment of cervical spondylosis with osteoporosis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Anterior Cervical Fusion with Stand-alone Trabecular Metal Cages to Treat Cervical Myelopathy Caused by Degenerative Disk Disease. Observations in 88 Cases with Minimum 12-month Follow-up. [2018]

5. Spain pubmed.ncbi.nlm.nih.gov

[Anterior cervical fusion with tantalum interbody implants. Clinical and radiological results in a prospective study]. [2016]

6. Australia pubmed.ncbi.nlm.nih.gov

Risk Factors of Nonfusion after Anterior Cervical Decompression and Fusion in the Early Postoperative Period: A Retrospective Study. [2023]

7. Belgium pubmed.ncbi.nlm.nih.gov

Anterior cervical interbody fusion with radiolucent carbon fiber cages: clinical and radiological results. [2018]

8. Australia pubmed.ncbi.nlm.nih.gov

Integral Fixation Titanium/Polyetheretherketone Cages for Cervical Arthrodesis: Evolution of Cage Design and Early Radiological Outcomes and Fusion Rates. [2021]