What side effects are associated with this type of intervention?

Common treatments for Degenerative Disc Disease, particularly those involving spinal fusion and vertebral augmentation, can have several side effects. Surgical interventions like spinal fusion may lead to complications such as infection, nerve damage, and issues related to the hardware used in the procedure. Vertebroplasty and kyphoplasty, which involve injecting cement into the vertebrae, can cause cement leakage, increased pain, and rarely, pulmonary embolism. Non-surgical treatments like bisphosphonates can lead to gastrointestinal issues, osteonecrosis of the jaw, and atypical femoral fractures, while parathyroid hormone analogs may cause hypercalcemia and injection site reactions. It is essential to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for Degenerative Disc Disease, including interbody fusion devices designed to enhance spinal fusion by matching a patient's bone density. One such product is the DEXA-C Anterior Cervical Interbody System, which is specifically designed to improve fusion rates by aligning with the patient's DEXA scan results. This approach aims to optimize the integration and stability of the implant, potentially leading to better clinical outcomes for patients with DDD.

What other types of research exist?

Promising novel alternatives for Degenerative Disc Disease treatment in 2024 include: 1) Biologics such as growth factors and stem cell therapy to promote natural disc regeneration and enhance fusion rates. 2) Minimally invasive surgical techniques like endoscopic discectomy and percutaneous spinal fusion, which reduce recovery time and surgical risks. 3) Advanced materials for spinal implants, including bioactive and bioresorbable materials that better integrate with the patient's bone and promote healing. These alternatives offer potential improvements in patient outcomes and recovery times.

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Interbody Device

DEXA-C Device for Degenerative Disc Disease (DEXA-C Trial)

N/A

Recruiting

Research Sponsored by Aurora Spine and Pain

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a neck surgery device designed to help adults with specific spine issues. The device is custom-fitted and helps neck bones fuse using bone grafts.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks associated with anterior cervical discectomy and fusion may include infection, bleeding, pain at the graft site, nerve damage leading to weakness or numbness, problems with voice or swallowing due to laryngeal nerve irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fusion Assesment

Secondary study objectives

Subsidence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm ObservationalExperimental Treatment1 Intervention

Cervical Interbody Cage

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Degenerative Disc Disease (DDD) include surgical interventions like spinal fusion and non-surgical options such as physical therapy and pharmacologic therapy. Spinal fusion, particularly with interbody products that match a patient's bone density, aims to stabilize the spine by fusing two or more vertebrae together, reducing pain and preventing further degeneration. This is achieved by placing bone grafts or synthetic materials between the affected vertebrae, promoting bone growth and fusion. Matching the interbody product to the patient's bone density can enhance the fusion rate, leading to better outcomes. Non-surgical treatments like physical therapy focus on strengthening the muscles around the spine, improving flexibility, and reducing pain. Pharmacologic therapies may include pain relievers and anti-inflammatory medications to manage symptoms. These treatments are crucial for DDD patients as they aim to alleviate pain, improve function, and prevent further spinal degeneration.