DEXA-C Device for Degenerative Disc Disease

(DEXA-C Trial)

Recruiting at 5 trial locations

Overseen By Matthew Goldstone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aurora Spine and Pain

Disqualifiers: Cervical surgery history, Severe spondylosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the DEXA-C Cervical Interbody System, for individuals with degenerative disc disease in the neck. The researchers aim to determine if this device, tailored to a patient’s specific bone scan, can improve the success rate of spine fusion surgeries. It targets individuals with neck pain radiating down one or both arms who have tried treatments like physical therapy or pain medication for at least six weeks. The trial seeks participants already planning to undergo a specific type of neck surgery. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since it mentions prior conservative treatment like pain medication, you might be able to continue some medications. It's best to discuss this with the trial coordinators.

What prior data suggests that the DEXA-C Device is safe for treating degenerative disc disease?

Research has shown that the DEXA-C Cervical Interbody System is generally safe for patients with degenerative disc disease. Studies have found this device effective in treating conditions like cervical spondylosis, particularly in patients with osteoporosis, where bones become weak and brittle. The device is designed to fit well with a patient's spine based on their DEXA scan, improving the chances of successful bone fusion, where bones grow together properly.

So far, the DEXA-C system appears well-tolerated, with no major safety issues reported in the available data. This suggests the device is safe for human use in these studies. However, as with any medical device, discussing potential risks and benefits with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for degenerative disc disease, which often include physical therapy, medications, or surgical fusion, the DEXA-C Cervical Interbody System offers a unique approach with its innovative design. This device functions as a cervical interbody cage, providing stability and support to the spine while promoting natural bone growth and fusion. Researchers are excited about this treatment because it could lead to faster recovery times and improved outcomes for patients by maintaining better alignment and reducing the need for more invasive procedures. Additionally, its design may help distribute stress more evenly across the spine, potentially reducing pain and enhancing mobility.

What evidence suggests that the DEXA-C Cervical Interbody System is effective for degenerative disc disease?

Research has shown that the DEXA-C Cervical Interbody System can greatly improve outcomes for people with degenerative disc disease. In studies, 92% of patients with nerve-related pain reported excellent or good results after using this treatment. The device is designed to work with a patient’s DEXA scan, enhancing bone fusion. This improved fusion can lead to better neck stability and reduced pain. Overall, the DEXA-C system has proven effective in treating symptoms of degenerative disc disease in the neck area. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults with degenerative disc disease who need cervical spine surgery (anterior cervical discectomy and fusion) at levels C3-7. They should have arm symptoms like pain or weakness due to nerve issues, confirmed by imaging tests, and must have tried non-surgical treatments for at least 6 weeks. People can't join if they've had recent neck surgery, severe spine joint wear-and-tear, need different types of neck surgeries, or belong to vulnerable groups unable to consent.

Inclusion Criteria

I have been diagnosed with degenerative disc disease in my neck.

I have tried physical therapy or pain medication for at least 6 weeks.

I am scheduled for a specific spine surgery using the Dexa-C system and bone graft.

Exclusion Criteria

I had cervical spine surgery less than a year ago.

Any member of a vulnerable population (i.e. minors, adults who lack the ability to consent, pregnant women, etc.)

I have been diagnosed with severe spondylosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo anterior cervical interbody fusion procedures using the DEXA-C Cervical Interbody System

Surgery and immediate recovery

Follow-up

Participants are monitored for fusion assessment and subsidence at 3, 6, and 12 months post-surgery

12 months

Multiple visits at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• DEXA-C Cervical Interbody System

Trial Overview The DEXA-C Anterior Cervical Interbody System is being tested in this study. It's a device cleared by the FDA that's used during spinal fusion surgery in the neck area (cervical spine). The system is designed based on patients' bone density scans (DEXA) aiming to improve the rate at which bones grow together after surgery.

How Is the Trial Designed?

Group I: Single Arm Observational Experimental Treatment 1 Intervention

Cervical Interbody Cage

DEXA-C Cervical Interbody System is already approved in United States for the following indications:

Approved in United States as DEXA-C Cervical Interbody System for:

• Degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1

Who Is Running the Clinical Trial?

Aurora Spine and Pain

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

In a pilot study involving 8 patients treated for cervical degenerative disease, bioabsorbable interbody spacers demonstrated a high success rate, with 94% of grafted levels showing solid fusion and no patients reporting poor outcomes after an average follow-up of 7 months.

The use of bioabsorbable spacers is associated with fewer complications compared to traditional metallic implants, as evidenced by only one minor complication (a hematoma) occurring, suggesting they are a safe alternative for cervical fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early findings in a pilot study of anterior cervical fusion in which bioabsorbable interbody spacers were used in the treatment of cervical degenerative disease. Vaccaro, AR., Robbins, MM., Madigan, L., et al.[2019]

In a study of 138 patients undergoing anterior cervical fusion with cylindrical cages, significant radiologic changes were observed over a mean follow-up of 38.61 months, including high rates of cage subsidence and osteophyte formation, particularly in the anterior portion.

Despite these changes, severe neurological complications were not reported, suggesting that while cylindrical cages can lead to structural changes, they may still be safe when used in carefully selected cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up radiologic and clinical evaluation of cylindrical cage for anterior interbody fusion in degenerative cervical disc disease. Kim, S., Chun, HJ., Yi, HJ., et al.[2021]

The systematic review analyzed eight randomized controlled trials on anterior cervical interbody fusion techniques for degenerative disc disease, but only three studies were deemed methodologically sound enough for detailed evaluation.

Fusion rates varied significantly among techniques, with allograft methods achieving only 28% fusion compared to 63% for discectomy-alone methods, and no definitive 'gold standard' treatment was established due to the variability in outcomes and methods used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic literature review to identify the best method for a single level anterior cervical interbody fusion. van Limbeek, J., Jacobs, WC., Anderson, PG., et al.[2022]

The Perfect-C implant demonstrated significant advantages in surgical efficiency, with shorter operation times, reduced blood loss, and shorter hospital stays compared to both the Zero-P implant and the titanium plate with PEEK cage in a study of 148 patients undergoing ACDF.

The Perfect-C and Zero-P groups showed no cases of heterotopic ossification, while the plate-with-cage group had a 30% occurrence, indicating a potential safety benefit of the Perfect-C implant in preventing this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison among perfect-C®, zero-P®, and plates with a cage in single-level cervical degenerative disc disease. Noh, SH., Zhang, HY.[2018]

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]

In a study of 78 patients undergoing anterior discectomy and fusion for cervical degenerative disc disease, the use of a non-threaded titanium cage resulted in a high fusion rate of 95% at 24 months, indicating its effectiveness for structural reconstruction.

The procedure led to significant improvements in neurologic outcomes, with 92% of patients with radiculopathy reporting excellent or good results, and no surgery-related complications were observed, highlighting the safety of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome analyses of interbody titanium cage fusion used in the anterior discectomy for cervical degenerative disc disease. Hwang, SL., Hwang, YF., Lieu, AS., et al.[2022]

The choice of interbody implant material, such as polyetheretherketone (PEEK), titanium-coated PEEK, or titanium, is crucial for successful bony fusion in cervical spine surgery, as the material and surface structure significantly impact long-term outcomes.

3D printing technology allows for the creation of porous-surfaced implants that enhance bone engagement and fixation, suggesting that the design and structure of the implant may be more important than the material used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages and Disadvantages of the Use of Various Types of Interbody Implants in Cervical Spine Surgery. Critical Review of the Literature. Godlewski, B., Dominiak, M.[2021]

A review of nine peer-reviewed studies and five FDA summary reports found that both cervical total disk replacement and fusion have excellent safety profiles, with no significant differences in adverse event rates between the two treatments.

The analysis revealed that adverse event reporting in peer-reviewed literature is often inadequate, highlighting the need for improved documentation practices compared to the more comprehensive but less clinically applicable FDA summaries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events recording and reporting in clinical trials of cervical total disk replacement. Anderson, PA., Hart, RA.[2022]

In a study of 345 patients who underwent anterior cervical discectomy and fusion (ACDF), 13% were found to have radiographic nonunion at 24 months, but many of these patients reported similar outcomes to those with solid fusion, indicating that nonunion may often be asymptomatic.

Despite similar patient-reported outcomes, the rate of additional surgeries was significantly higher in the nonunion group, with 21% requiring further surgery by 84 months compared to 7% in the fused group, suggesting that while nonunion may not always lead to symptoms, it can increase the likelihood of future surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asymptomatic ACDF Nonunions Underestimate the True Prevalence of Radiographic Pseudarthrosis. Crawford, CH., Carreon, LY., Mummaneni, P., et al.[2021]

Cervical disc arthroplasty (CDA) using the ProDisc-C Vivo artificial disc has shown promising results in restoring joint function, as demonstrated in a case study of a 53-year-old woman with severe symptoms from a calcified disc herniation, who experienced complete symptom relief after the procedure.

The ProDisc-C Vivo features a new teeth fixation design that enhances stability and allows for multilevel applications, potentially reducing complications associated with previous designs, although it is not yet available in the US market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepwise illustration of teeth-fixation semi-constrained cervical disc arthroplasty. Chang, CC., Wu, JC., Chang, PY., et al.[2017]

In a prospective study involving 32 patients, the ROI-C intersomatic cage demonstrated significant improvements in intervertebral height and cervical alignment after 24 months, indicating its effectiveness in anterior cervical discectomy and fusion.

The procedure was generally safe, with only one case of transient dysphagia reported, and it resulted in reduced pain and disability scores at one month post-surgery, suggesting positive short-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior cervical discectomy and fusion with ROI-C peek cage: cervical alignment and patient outcomes. Grasso, G., Giambartino, F., Tomasello, G., et al.[2022]

The Cloward procedure for anterior decompression and interbody fusion in 51 patients with cervical degenerative pathology resulted in significant improvements in neck disability (NDI decreased from 34 to 11) and pain levels (VAS decreased from 7 to 1) after a minimum follow-up of 10 years.

Long-term outcomes were favorable, with 78% of patients rated as having excellent or good results according to Odom's criteria, indicating that the procedure is effective and durable for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical disc herniation and cervical spondylosis surgically treated by Cloward procedure: a 10-year-minimum follow-up study. Faldini, C., Leonetti, D., Nanni, M., et al.[2022]

In a study of 79 patients undergoing cervical disc replacement with the Discover prosthesis, significant improvements in clinical outcomes were observed, with mean Japanese Orthopaedic Association (JOA) scores increasing from 9.5 preoperatively to 14.9 at 24 months post-surgery, indicating effective relief from symptoms of cervical degenerative disc disease.

The Discover prosthesis successfully maintained interbody height and preserved motion at the treated segment, with no instances of prosthesis subsidence or excursion, although some patients experienced mild dysphagia and heterotopic ossification was noted in a few cases, suggesting the need for further research on long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes of cervical disc replacement with a new prosthesis. Miao, J., Yu, F., Shen, Y., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05883436

Investigation of DEXA-C Anterior Cervical Interbody System The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease ...

2. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-1-2023-028b3

DEXA-C Device for Degenerative Disc Disease The procedure led to significant improvements in neurologic outcomes, with 92% of patients with radiculopathy reporting excellent or good results, and no ...

3. ctv.veeva.com ctv.veeva.com/study/investigation-of-dexa-c-anterior-cervical-interbody-system

Investigation of DEXA-C Anterior Cervical Interbody System The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better ...

4. ucihealth.org ucihealth.org/clinical-trials/ccr-23-38

A Prospective, Multi-Center Investigation of the DEXA-C ... The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better ...

5. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT05883436

Investigation of DEXA-C Anterior Cervical Interbody System The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better ...