What side effects are associated with this type of intervention?

Common side effects of total disc replacement (TDR) for Cervical Disc Disease include headache, neck pain, and dysphagia. Other potential complications can include implant migration, adjacent segment disease, and, less frequently, infection or neurological deficits. These side effects are generally consistent across different TDR devices.

What prior FDA approvals exist?

The FDA has approved several total disc replacement (TDR) devices for the treatment of Cervical Disc Disease (CDD) to maintain motion and alleviate symptoms. Notably, the Mobi-C® Cervical Disc is an FDA-approved TDR device used for treating symptomatic cervical disc disease at two contiguous levels. These devices aim to preserve the natural movement of the cervical spine while providing relief from pain and other symptoms associated with CDD.

What other types of research exist?

Promising alternatives to the BAGUERA®C Cervical Disc Prosthesis for treating Cervical Disc Disease in 2024 include the Mobi-C® Cervical Disc, which is already a well-established option. Additionally, emerging therapies such as the use of biologics for disc regeneration, advanced minimally invasive surgical techniques, and new total disc replacement devices currently under clinical investigation may offer effective alternatives. Patients should discuss these options with their healthcare provider to determine the best course of treatment based on the latest available evidence and their specific medical condition.

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Prosthesis

BAGUERA®C vs Mobi-C for Cervical Disc Disease

N/A

Waitlist Available

Research Sponsored by Spineart USA

Eligibility Criteria Checklist

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

Must have

Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following: Neck and/or arm pain (at least 40 mm on the 100 mm visual analogue scale [VAS] scale). Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. Abnormal sensation including hyperesthesia or hypoesthesia; and/or Abnormal reflexes.

Male or female; skeletally mature; age 22-69 years, inclusive.

Must not have

Radiographic confirmation of severe facet joint degeneration or confirmed clinical evidence that facet joint degeneration is a major contributor to the subject's pain.

Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new neck disc replacement device called BAGUERA®C on patients with neck disc problems. The device aims to replace damaged discs, helping to restore normal movement and reduce pain.

Who is the study for?

Adults aged 22-69 with cervical disc disease at two levels from C3 to C7, experiencing neck or arm pain and other symptoms despite non-operative treatment. Must have certain radiographic signs of degeneration or herniation, be medically cleared for surgery, and able to follow the study protocol. Excludes those with severe bone diseases, prior cervical surgeries, infections, certain allergies, autoimmune diseases affecting musculoskeletal system, obesity (BMI > 40), heavy nicotine use or substance abuse.

What is being tested?

The trial is comparing BAGUERA®C Cervical Disc Prosthesis with Mobi-C® Cervical Disc in treating symptomatic cervical disc disease. Participants are randomly assigned in a 2:1 ratio to either the investigational device (BAGUERA®C) or control device (Mobi-C®). They will be monitored from pre-surgery up until seven years post-surgery.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, infection risks associated with surgery, allergic reactions to materials in the devices if sensitivity exists. Long-term effects could involve issues related to wear and tear of prosthetic components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have neck or arm pain, weakness, unusual sensations, or reflex problems due to a spine condition.

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I am between 22 and 69 years old and fully grown.

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I have neck pain due to issues in my cervical spine at two levels between C3 and C7.

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I am approved by a doctor to have surgery.

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My muscle strength has decreased by at least one level.

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I have nerve pain or weakness in my neck or arms from a spine condition.

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My symptoms from nerve or spinal cord compression are getting worse despite treatment.

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I have neck or arm pain rated at least 40 out of 100.

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I am a candidate for surgery from the front of my neck and have not had previous neck surgeries.

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I have back or neck issues confirmed by scans and significant pain or disability.

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My neck or arm pain score is 40 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My severe back pain is due to facet joint problems confirmed by tests.

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I have had a serious neck injury between the C3 and C7 vertebrae.

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I have an autoimmune disease like rheumatoid arthritis or lupus.

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I have a bone condition that is not osteoporosis.

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I am not on high-dose steroids or medications that affect healing.

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I have more than one fused spine bone in my neck from any cause.

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I take high doses of steroids daily.

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I take 5 mg or more of oral steroids every day.

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I use inhaled corticosteroids twice a day every day.

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I have a birth defect in my bones or spinal cord that affects my spine's stability.

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I am currently experiencing a confirmed episode of a specific mental illness or have physical symptoms without a medical diagnosis.

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I haven't taken high doses of oral steroids for short periods recently.

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I have a crack or stress fracture in my spine.

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I have seizures that are not controlled by medication.

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I have had spine surgery at the same spot before.

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I have had a spine surgery in my neck area before.

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I do not have conditions like neuromuscular disorders that would affect my clinical evaluation.

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My neck X-rays show significant instability.

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I have severe neck pain or problems due to spine issues at more than two levels.

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I do not have any ongoing infections.

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I have or might need treatment for an active infection like HIV or Hepatitis C.

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I manage my severe diabetes with daily insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month follow-up visit for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maintenance or improvement in neurological status

Neck Disability Index

No secondary surgical intervention per protocol definition

+1 more

Side effects data

From 2014 Phase 3 trial • 600 Patients • NCT01801735

Urinary tract infection

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Meloxicam 10 mg

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BAGUERA®CExperimental Treatment1 Intervention

surgical placement of the BAGUERA®C Cervical Disc Prosthesis at 2 contiguous levels

Group II: Mobi-C®Active Control1 Intervention

surgical placement of the Mobi-C® Cervical Disc at 2 contiguous levels

0 / 33Eligibility criteria met

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

Total disc replacement (TDR) for Cervical Disc Disease (CDD) involves replacing a damaged cervical disc with an artificial disc to maintain the natural motion of the spine and alleviate symptoms such as pain and neurological deficits. This approach helps preserve the range of motion and reduces stress on adjacent discs, potentially preventing further degeneration. For CDD patients, this means better long-term outcomes and a lower risk of additional spinal issues compared to traditional fusion surgeries, which limit spinal mobility.

Manual therapy interventions in the management of adults with prior cervical spine surgery for degenerative conditions: a scoping review.Evaluation of treatment effectiveness for the herniated cervical disc: a systematic review.