prodisc C SK and/or Vivo for Intervertebral Disc Displacement

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Legacy Brain and Spine, Atlanta, GA
Intervertebral Disc Displacement+2 More
prodisc C SK and/or Vivo - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a total disc replacement device may help treat cervical disc disease.

See full description

Eligible Conditions

  • Intervertebral Disc Displacement
  • Symptomatic Cervical Disc Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Intervertebral Disc Displacement

Study Objectives

This trial is evaluating whether prodisc C SK and/or Vivo will improve 1 primary outcome in patients with Intervertebral Disc Displacement. Measurement will happen over the course of 24 months.

24 months
Composite clinical success rate of the two-level prodisc C SK and prodisc C Vivo will be no worse than marketed cervical disc prosthesis (Mobi-C)

Trial Safety

Safety Progress

1 of 3

Other trials for Intervertebral Disc Displacement

Trial Design

2 Treatment Groups

Control
1 of 2
Investigational
1 of 2
Active Control
Experimental Treatment

This trial requires 390 total participants across 2 different treatment groups

This trial involves 2 different treatments. Prodisc C SK And/or Vivo is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Investigational
Device
Two-level prodisc C SK and/or prodisc C Vivo
Control
Device
Two-level Mobi-C device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

Legacy Brain and Spine - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥18 and ≤69 years.
You have SCDD at two contiguous levels from C3 to C7. show original
You are not responsive to non-operative, conservative treatment. show original
Radiographically determined pathology at the level to be treated correlating to primary symptoms. show original

Patient Q&A Section

What does prodisc c sk and/or vivo usually treat?

"ProDisc C Sk implantation may be a new procedure to treat disc bulges (protrusion or herniation) associated with disc degeneration and/or osteoarthritis. The ProDisc C Sk procedure is also sometimes used as part of a total disc replacement. This procedure may not only relieve one or more symptoms but also improve or relieve the patient's overall health condition." - Anonymous Online Contributor

Unverified Answer

What are common treatments for intervertebral disc displacement?

"Surgery is most often used for intervertebral disc displacement, since there is little definitive evidence as to the efficacy of nonsurgical management options. In some individuals with low [back pain](https://www.withpower.com/clinical-trials/back-pain) attributable to disc displacement, surgical fusions may relieve pain and improve function. In cases of severe, disabling pain, conservative treatment may be recommended first, using a combination of nonsteroidal anti-inflammatories, physical therapy, and traction for 12 weeks. If there is no improvement, then, owing to an incomplete understanding of the biomechanics of disc displacement, surgical fusion may be necessary. If surgery is indicated, spinal fusion is usually a choice for those with pain>6+ years in duration, or disability>12 months when conservative therapy has failed." - Anonymous Online Contributor

Unverified Answer

What causes intervertebral disc displacement?

"Recent findings showed that a significant correlation did exist between the height of intervertebral disc height and disc height of adjacent disc. The height of the adjacent disc was significantly correlated with the disk height of the presenting segment. Therefore, we suggest that there is a significant relation between intervertebral disc height and the height of adjacent disc." - Anonymous Online Contributor

Unverified Answer

How many people get intervertebral disc displacement a year in the United States?

"Approximately 1.1 million adults experience IDD annually. Intervertebral disc degeneration can cause degenerative disc disease, which may result in IDD; however, the rate of IDD in the general population is unknown. Physicians and those in spinal surgery, health policy, and quality initiatives are needed to make the case for early treatment of IDD." - Anonymous Online Contributor

Unverified Answer

What are the signs of intervertebral disc displacement?

"Intervertebral discs may be herniated, or they may be compressed. A combination of symptoms (back pain, leg pain, and weakness) is the most common presentation." - Anonymous Online Contributor

Unverified Answer

What is intervertebral disc displacement?

"The achilles tendon is a common anatomic abnormality of the back. It is common in patients with [degenerative disc disease](https://www.withpower.com/clinical-trials/degenerative-disc-disease) and is more frequent in patients with chronic discogenic pain. The clinical significance of the tendon remains controversial. When it can be identified on radiographs, it tends to cause disc displacement. It does not necessarily cause intervertebral disc space narrowing." - Anonymous Online Contributor

Unverified Answer

Can intervertebral disc displacement be cured?

"Many patients with intervertebral disc displacement do well and can return to their normal work. We conclude that intervertebral disc displacement can, in our case, not be cured and should not be considered a degenerative disease." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of prodisc c sk and/or vivo?

"The most commonly reported adverse events in this study were [back pain](https://www.withpower.com/clinical-trials/back-pain), sciatica, or buttock pain (both in more than one case), and a number of cases of constipation or diarrhea." - Anonymous Online Contributor

Unverified Answer

How serious can intervertebral disc displacement be?

"Although many patients with severe disc displacement can recover within 6 months and can be treated conservatively, the disability in those patients is serious and can last for years. If symptoms are severe enough to interrupt activities for longer than 2 months, these symptoms may never go away. Treatment with surgery is not advisable." - Anonymous Online Contributor

Unverified Answer

Is prodisc c sk and/or vivo typically used in combination with any other treatments?

"There is no evidence to support that prodisc c sk and/or vivo can cause additional vertebral disc decompression when other treatments are used to treat disc displacement. This conclusion is based on evidence derived from two systematic reviews that included studies of patients receiving prodisc c sk and/or vivo alone or combined with other treatments, including patients receiving other epidural drug treatments." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of intervertebral disc displacement?

"[Disc protrusions or “flattened discs” are a natural part of the aging spine, but when present in high enough numbers, can be an issue for pain and disability in the affected individual. In some instances, the condition might actually be a sign of disease or malignancy; therefore, further study is recommended to explore underlying causes. If that fails, in many cases treatment of the primary (i.e., “secondary”) condition will correct symptoms; therefore, it is very important to have a clear history of that individual’s condition prior to deciding whether to submit to spinal diagnostic imaging for evaluation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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