Decompression using the iO-Flex® system for Olisthesis

1
Effectiveness
1
Safety
Tuckahoe Orthopedics, Richmond, VA
Olisthesis+3 More
Decompression using the iO-Flex® system - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Olisthesis

Study Summary

This study is evaluating whether a surgery using a device to open up the spinal canal can help people with back pain.

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Eligible Conditions

  • Olisthesis
  • Spondylolisthesis
  • Spinal Stenosis
  • Radiculitis
  • Radiculopathy
  • Spinal Stenosis of Lumbar Region

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Decompression using the iO-Flex® system will improve 6 secondary outcomes in patients with Olisthesis. Measurement will happen over the course of Operative (day 1).

Month 60
Numerical Rating Scale (NRS)
Oswestry Disability Index (ODI)
SF-36 Health Survey
Zurich Claudication Questionnaire (ZCQ)
Month 60
Treatment survival rate
Operative (day 1)
Operative success

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Surgery

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. Decompression Using The IO-Flex® System 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.

Surgery
Procedure
Decompression using the iO-Flex® system
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, 24, 36, 48 and 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6, 12, 24, 36, 48 and 60 months for reporting.

Closest Location

Tuckahoe Orthopedics - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is required A person must be able to give voluntary, written informed consent to participate in this clinical investigation and be able to participate in follow up examinations and complete patient questionnaires. show original
The text confirms that patients with central and/or lateral recess stenosis and spondylolisthesis at one level may have symptomatic central, lateral recess, or foraminal stenosis treated at one adjacent level show original
without spinal stenosis Grade 1 spondylolisthesis is a condition in which the vertebrae in the spine slip out of place show original
The NRS pain score for leg pain of 4/10 or greater is a measure of the pain a person is experiencing. show original
A score of 30/100 or greater on the ODI scale indicates a severe level of disability. show original
The term adult refers to someone who is 18 years of age or older. show original
Leg/buttock pain, with or without back pain
Many people with chronic pain have tried non-operative medical management for at least six months without success. show original
Confirmed clinical diagnosis of lumbar spinal stenosis

Patient Q&A Section

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

What is olisthesis?

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Olisthesis is a condition that involves overuse of one or more body joints. It may result from stress, trauma, genetics, or infection. It is best known in regards to its connection to athletes. In more common individuals, it is also frequently linked to repetitive work, such as those who are carpenters, plumbers, construction workers, and mechanics. Ollisthesis may be a form of musculoskeletal disorder. Although olisthesis can be found in patients who develop this disorder, it is not the only cause. Often, olisthesis is found in cases of trauma, stress, fatigue, or arthritis.

Unverified Answer

What causes olisthesis?

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Recent findings shows that olisthesis is not related to temporomandibular joint disease. It is theorized that olisthesis is a normal, self-limited finding in the temporomandibular joints.

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

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The present information is of limited usefulness for establishing the prevalence of olisthesis and should only be used as a reference when obtaining estimates of prevalence.

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What are common treatments for olisthesis?

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Surgical procedures appear to be the most common treatment for cervical spine olisthesis. Laminectomy was the most common surgery for cervical spine olisthesis (31%). Surgery also appears to be frequently performed for thoracolumbar olisthesis. While spine fusion surgeries appear to be commonly performed for thoracolumbar olisthesis in some studies, they are not routinely used in this patient population. Fussell rods are also commonly used to treat olisthesis, both of the cervical and thoracolumbar spine. The most common interventions for spinal olisthesis are decompressive laminotomies; however, most patients do not respond to decompressive laminotomies, nor do they necessarily recover fully from them.

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Can olisthesis be cured?

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No successful treatment has been described in a large series of theses cases. We consider it necessary to use surgical correction as this is our policy. A conservative approach towards the treatment in case of failure of the results is recommended.

Unverified Answer

What are the signs of olisthesis?

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Olisthesis is uncommon and rarely presents as a symptom of degenerative disease of the spine. The signs and symptoms are often vague and non-specific. If any of the signs or symptoms discussed above are found, examination of the blood may reveal abnormalities. The first line of investigation of olisthesis is X-rays, especially of the spine. If X-rays are normal, magnetic resonance imaging of the spine or an MRI scans of the whole spine or chest would be further investigations. Bone scans, scans of the brain, or a computed tomography (CT or CAT scan) of the head, chest or spine may aid in the diagnosis of olisthesis.

Unverified Answer

How does decompression using the io-flex® system work?

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Decompressive therapy using the io-flex system is an effective treatment method for axillary olisthesis. It is also a safe and minimal invasive procedure, and the postoperative rehabilitation process after decompression should be minimal.

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How serious can olisthesis be?

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Olisthesis is a very serious condition that can result in significant pain, loss of skeletal function, and, ultimately, the loss of your limb. In the case of olisthesis, orthoses are the most effective form of treatment. You can find orthoses from a number of manufacturers by using [PhysioSite] (https://www.physiotech.com/pages/orthoses).

Unverified Answer

Who should consider clinical trials for olisthesis?

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Clinical trials have proven to have a significant impact on the management of those with O and on patient-reported outcomes, including olisthesis. They are necessary for clinicians to make a more informed, comprehensive treatment decision for patients with O, and for surgeons to make an optimized operative and rehabilitation strategy.

Unverified Answer

What is the latest research for olisthesis?

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There seems to be a lack of research investigating the effects of weight bearing on olisthesis. Given the strong association of weight bearing and olisthesis, future research is required to look at the effect of altered weight bearing and loading mechanisms on olisthesis.

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Is decompression using the io-flex® system safe for people?

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A retrospective review of a large series of patients treated for spondylolisthesis using the io-flex® system. Decompression using the io-flex® system appears to represent an effective and safe technique.

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Have there been other clinical trials involving decompression using the io-flex® system?

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There have been at least 14 published studies that demonstrated no statistically significant short-term (8 weeks) improvements in symptom relief and improvement in functionality. These preliminary reports are as follows:\n1. Decompression of subarticular disks using the io-flex system. The study was conducted in conjunction with the University of Minnesota's Department of Orthopaedic Surgery and was performed by Dr. David W. B. Hirsch. A cohort study of 50 patients with degenerative disk disease. The primary outcome measures were improvement of symptoms, improvements in range of motion, and improvements in functional limitations. For patients who improved after decompression using the io-flex system, the mean improvement in functional limitation was -4.8 points.

Unverified Answer
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