Treatment for Cervical Spondylosis With Myelopathy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Wayne State University, Detroit, MI
Cervical Spondylosis With Myelopathy+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a bone graft substitute can be used to fuse a spine.

See full description

Eligible Conditions

  • Cervical Spondylosis With Myelopathy
  • Cervical Spine Degenerative Disease Nos

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Cervical Spondylosis With Myelopathy. Measurement will happen over the course of Baseline, 6 weeks, 6 months, 12 months, 24 months.

Month 24
Change in Clinical Outcomes
Change in Fusion Rates

Trial Safety

Trial Design

0 Treatment Group

This trial requires 40 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 weeks, 6 months, 12 months, 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 6 weeks, 6 months, 12 months, 24 months for reporting.

Who is running the study

Principal Investigator
H. E.
Prof. Hazem Eltahawy, MD
Wayne State University

Closest Location

Wayne State University - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject is an adult, and they are of legal age to consent. show original
The subject is able to comply with the required post-operative care, follow-up visits, and informed consent show original
The subject agrees to participate in post-operative clinical and radiographic follow-up evaluations for 2 years. show original
This person has failed conservative treatments and may need surgery to fuse their spine. show original
The person who is to be studied has agreed to take part in the study after being fully informed about it. show original
A woman who is capable of becoming pregnant must not be pregnant or nursing, and agrees not to become pregnant for one year after surgery. show original
The subject is no longer growing. show original
No previous surgery at the levels where the fusion is taking place. show original

Patient Q&A Section

Who should consider clinical trials for spondylosis?

"Clinicians must be cautious in drawing comparisons. While we found clinically reasonable equivalence for patients who were considered for enrollment in spondylosis clinical trial, patients with more severe degenerative changes may be less likely to benefit, especially at longer follow-up." - Anonymous Online Contributor

Unverified Answer

What are the signs of spondylosis?

"Data from a recent study showed that patients with SpA had a significantly higher symptom severity score than normal subjects, especially in the lumbar spine. The mean values for spinal mobility were worse in patients with SpA than in normal subjects, and the degree of decline in these parameters increased as the disease progressed." - Anonymous Online Contributor

Unverified Answer

What is spondylosis?

"Spondylosis is currently a disease with considerable diagnostic accuracy and is the leading cause of low back pain. It is a condition that affects more women than men; there is no clear link to any risk factors. The prevalence of spondylosis increases with age and increases in both males and females, but there is no link to race or marital status. The prevalence of spondylosis between 20 to 50 years tends to be higher than it is in the elderly. The risk of developing the disease is high due to a combination of occupational and individual factors." - Anonymous Online Contributor

Unverified Answer

What causes spondylosis?

"Spondylosis begins as early as age 50. The cause of spondylosis is thought to be multifactorial, with genetic, lifestyle and environmental factors all thought to have a role in the pathophysiology. The exact contribution of each of these factors is yet to be determined.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for spondylosis?

"What is commonly done for treatment of radiculopathy? There have been many trials evaluating the effectiveness of non-operative treatments in the treatment of radiculopathy. Most studies indicate that conservative interventions can be effective in providing relief to patients without compromising their overall function. Although there are a number of non-invasive methods available for treatment of radiculopathy (including corticosteroids, and other medications), an effective treatment method is yet to be developed and identified. The optimal treatment can only be determined following thorough clinical evaluation." - Anonymous Online Contributor

Unverified Answer

Can spondylosis be cured?

"Spondylosis is a common condition and often unrecognised, though it can rarely be cured. The aim of these investigations, as well as the current evidence-base, suggests that surgery is not the preferred and most effective treatment for spondylosis, especially in patients with mild-to-moderate symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get spondylosis a year in the United States?

"Approximately 17.2 million adults have already been diagnosed with lumbar spondylosis in 2011, and another 25.8 million may be diagnosed in the future. It is estimated that 9.1 million new cases of lumbar spinal stenosis will be diagnosed in 2016." - Anonymous Online Contributor

Unverified Answer

What is the latest research for spondylosis?

"There’s no scientific evidence supporting the effectiveness of treatment for pain and stiffness, and no evidence supports the claim that it is possible to prevent, delay or reverse spondylosis. There is insufficient evidence for treatment for post-surgical back pain and spinal cord injury. There are many different treatments out for spondylosis with limited evidence supporting the most effective with most of these treatments having serious side effects, and more research is required to find the most effective one. There is no evidence to suggest that physiotherapy, acupuncture or counselling are an effective way of managing the condition." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"Nonoperative treatment is a valid option for the management of ASL. Surgical treatment for ASL was reported to be effective in only 12% of the cases. However, none of the 12 cases with surgical management of ASL had symptomatic improvement in the course of their treatment. Nonoperative treatment should always be considered as first-line therapy in ASL." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"In the majority of cases, the patient received a combination of medication used in the treatment of spondylosis, with the use of the following categories: non-opioid analgesics, anti-inflammatory, and anti-osteoarthritic agents. Recent findings show the importance of educating patients and prescribers on the most up-to-date recommendations for treatment." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with spondylosis?

"This was not a controlled study, so it is not possible to know how well the drugs were actually working. However, our results do suggest that certain kinds of drugs may be useful for alleviating pain and improving a person's quality of life. For more information on treatment options for pain, look at [www.withpower.com/d/pain-treatment-options]. We also recommend reading about several potential treatments on this site: (a) spondylosis treatment, (b) spinal fusion treatment, and (c) fusion surgery treatments." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"With a careful examination of the various ways that interventions affect the neck and lower back, you can help doctors and patients to make the most informed decisions about treatment of the degenerative back condition. You can read about the clinical trials that support your choice of treatment by finding clinical trials trials using the Power Suite." - 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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