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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of interbody cages used in neck surgery for individuals with cervical myelopathy, a condition that causes pressure on the spinal cord in the neck. One group will receive a new cage with technology designed to enhance bone integration, while the other group will receive a standard cage selected by the surgeon. The researchers aim to determine if the new cage improves surgery success and recovery. This trial suits patients who have not had previous neck surgery and are undergoing ACDF for cervical spine degeneration issues. As an unphased trial, it enables patients to contribute to advancing surgical technology and improving future treatment options.

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 prior data suggests that these interbody cages are safe for cervical myelopathy?

Research shows that the Titan nanoLOCK interbody cage, tested in this trial, is designed to enhance bone healing after spine surgery. This cage uses special technology to promote bone growth. Studies have found that this type of cage is generally well-tolerated by patients.

However, safety concerns should be noted. Some reports have mentioned issues with similar devices, such as pain or device movement, though these cases are uncommon. The FDA has approved the Titan nanoLOCK cage for use, indicating it meets certain safety standards.

Overall, available data suggest that this cage is safe for use in spine surgery. However, as with any medical device, a small risk of complications exists. Discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Titan nanoLOCK interbody cage for cervical myelopathy because it features nanoLOCK osseointegrative technology, which aims to enhance bone integration and stability. Unlike standard treatments like traditional ACDF interbody cages, which do not use this advanced surface technology, the nanoLOCK cages may promote better fusion with the vertebrae. This could potentially lead to improved outcomes and faster recovery times for patients dealing with cervical myelopathy.

What evidence suggests that this trial's interbody cages could be effective for cervical myelopathy?

Research shows that the Titan nanoLOCK interbody cage, which participants in this trial may receive, effectively treats cervical myelopathy, a condition affecting the spinal cord in the neck. Studies have found that titanium cages with nanoLOCK technology promote bone growth into and around the device, enhancing spine stability. This can lead to better healing and may reduce the need for additional support, such as screws. Patients using similar titanium cages have experienced positive outcomes, suggesting that the Titan nanoLOCK cage could be a good option for those undergoing ACDF, a type of neck surgery. Participants in the control group of this trial will receive an alternative interbody cage system that does not use nanoLOCK osseointegrative technology. ^{1 2 3 6 7}

Who Is on the Research Team?

Salah Aoun, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05762055

Prospective Comparative Analysis of ACDF vs Fusion ... In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.

2. withpower.com withpower.com/trial/phase-radiculopathy-3-2023-3ebaf

Interbody Cages for Cervical Myelopathy · Info for Participants Trial Overview The study compares two types of interbody cages used in ACDF surgery: Titan nanoLOCK cage with osseointegrative technology versus a standard cage ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3535245/

Relevance of expandable titanium cage for the treatment ... Conclusion. Expandable titanium cage is an effective device for the treatment of cervical spondylotic myelopathy. It is associated with a good clinical outcome ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K211258.pdf

K211258.pdf - accessdata.fda.gov When used without the integrated screws, the Endoskeleton™ TCS Interbody System requires additional supplemental fixation cleared by the FDA for ...

5. neurospineproductreview.com neurospineproductreview.com/endoskeleton-tcs-titanium-nanolock-integrated-standalone-acdf-spacer

Endoskeleton TCS Titanium nanoLOCK Integrated ... The Endoskeleton TCS is a Titanium standalone ACDF spacer with integrated screw fixation. The titanium endplates are surface etched using Titan Spine nanoLOCK ...

6. thespinemarketgroup.com thespinemarketgroup.com/wp-content/uploads/2016/07/Endoskeleton-Cervical-Brochure.Medtronic-Titan-Spine.pdf

Endoskeleton Cervical-Brochure.Medtronic (Titan Spine).pdf Proprietary nanoLOCK® Titanium Surface. Macro textures on the superior and inferior surfaces promote immediate mechanical fixation.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11185085&pc=OVE

MAUDE Adverse Event Report: TITAN MANUFACTURING ... MAUDE Adverse Event Report: TITAN MANUFACTURING MEQUON ENDOSKELETON TCS INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL