What is the mechanism of action of this treatment?

Total disc replacement (TDR) is a common treatment for Cervical Disc Disease that involves replacing a damaged cervical disc with an artificial one to restore normal disc function and alleviate symptoms. This procedure helps maintain the natural movement and flexibility of the cervical spine, reducing pain and preventing further degeneration. Other common treatments include physical therapy, which strengthens neck muscles and improves range of motion, and medications like NSAIDs to reduce inflammation and pain. These treatments are crucial for managing symptoms and improving the quality of life for patients with Cervical Disc Disease.

What side effects are associated with this type of intervention?

Total disc replacement (TDR) for cervical disc disease, such as the BAGUERA®C Cervical Disc Prosthesis, generally aims to restore normal disc function and alleviate symptoms. Common side effects associated with TDR include neck pain, headache, and dysphagia (difficulty swallowing). Other potential complications can include implant migration, adjacent segment disease, and, in rare cases, neurological deficits. These side effects are generally comparable to those observed with other cervical disc prostheses like the Mobi-C® Cervical Disc.

What prior FDA approvals exist?

The FDA has approved several total disc replacement (TDR) devices for the treatment of Cervical Disc Disease, aimed at restoring normal disc function and alleviating symptoms. Notable examples include the Mobi-C® Cervical Disc, which is used as a control in the BAGUERA®C clinical trial. These devices are designed to maintain motion at the treated spinal level, offering an alternative to traditional spinal fusion surgery. The approval of such devices is based on their ability to provide pain relief, improve function, and maintain cervical spine mobility.

What other types of research exist?

Promising alternatives to the BAGUERA®C Cervical Disc Prosthesis for treating Cervical Disc Disease include the Mobi-C® Cervical Disc, which is already a well-established option. Additionally, other novel devices such as the Prestige LP Cervical Disc and the ProDisc-C Vivo are gaining attention due to their positive clinical outcomes and regulatory approvals. These devices aim to restore normal disc function and alleviate symptoms effectively.

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Device

BAGUERA®C vs. Mobi-C® Implants 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

Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.

Medically cleared for surgery.

Must not have

- Daily, chronic use of oral steroids of 5 mg/day or greater.

Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the BAGUERA®C Cervical Disc Prosthesis to another similar device in patients with neck pain due to damaged discs. The artificial disc aims to relieve pain and restore neck movement. Patients will be monitored before and after surgery for an extended period. The BAGUERA®C Cervical Disc Prosthesis is part of a broader category of cervical disc replacements, which have been studied for their long-term outcomes and effectiveness in treating degenerative cervical disc disease.

Who is the study for?

This trial is for adults aged 22-69 with cervical disc disease causing neck/arm pain, weakness, or abnormal sensations. Participants must have tried non-surgical treatments without success and be fit for surgery. Exclusions include prior surgeries at the affected level, infections, severe diabetes, obesity (BMI > 40), osteoporosis/osteopenia, autoimmune diseases affecting muscles/bones, and allergies to certain metals.

What is being tested?

The study compares two types of cervical disc prostheses: BAGUERA®C and Mobi-C®, in patients with symptomatic cervical disc disease. It's a randomized controlled trial where subjects are assigned to either device in a 2:1 ratio and followed up from surgery through seven years post-operation.

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 (like Titanium or polyethylene), nerve damage leading to persistent pain or weakness, and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

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

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My muscle strength has decreased by at least one level.

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My doctor has approved me for surgery.

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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 neck pain due to a problem with a disc in my neck.

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

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My neck or arm pain score is 40 or more out of 100.

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I have neck or arm pain, weakness, numbness, or unusual reflexes due to a nerve issue in my neck.

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I have neck or arm pain rated at least 4 out of 10.

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

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My muscle strength has decreased by at least one level.

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

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My neck or arm pain score is 40 or more.

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

Exclusion Criteria

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

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

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I have a bone condition that is not osteoporosis.

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I manage my severe diabetes with daily insulin.

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I had a cervical spine steroid injection within the last 14 days.

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I have neck pain due to cervical spine issues at multiple levels.

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I do not have conditions like neuromuscular disorders that would make it hard to assess my disease accurately.

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

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I have had spine surgery at the same spot before.

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I have seizures that are not controlled by medication.

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I take high doses of steroids daily.

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I use inhaled corticosteroids twice a day every day.

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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 have an autoimmune disease like rheumatoid arthritis or lupus.

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

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I have birth defects in my bones or spinal cord that affect my spine's stability.

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

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I have a crack or stress fracture in one of my vertebrae.

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I have had spine surgery in my neck before.

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I do not have any ongoing infections.

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I haven't taken high-dose steroids for short periods recently.

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

Group II: Mobi-C®Active Control1 Intervention

surgical placement of the Mobi-C® Cervical Disc

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) is a common treatment for Cervical Disc Disease that involves replacing a damaged cervical disc with an artificial one to restore normal disc function and alleviate symptoms. This procedure helps maintain the natural movement and flexibility of the cervical spine, reducing pain and preventing further degeneration. Other common treatments include physical therapy, which strengthens neck muscles and improves range of motion, and medications like NSAIDs to reduce inflammation and pain. These treatments are crucial for managing symptoms and improving the quality of life for patients with Cervical Disc Disease.

Manual therapy interventions in the management of adults with prior cervical spine surgery for degenerative conditions: a scoping review.