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Total Joint Replacement
MOTUS Device for Lumbar Spine Degeneration
N/A
Recruiting
Research Sponsored by 3Spine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disc degeneration and/or annular degeneration; and/or Lumbar stenosis defined by spinal cord or nerve root compression
Spondylosis (defined by the presence of osteophytes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month
Awards & highlights
Study Summary
This trial will compare the safety and effectiveness of a new lumbar spine surgery device to a current standard procedure.
Who is the study for?
Adults aged 21-80 with symptomatic lumbar spine degeneration, confirmed by imaging and a disability score over 40/100. Candidates must have tried conservative treatments for at least 3 months, be able to follow the study protocol, and not be pregnant or planning pregnancy within three years. Exclusions include severe obesity (BMI >40), certain allergies, current smokers, multiple spinal level issues, and various medical conditions that could affect bone healing or participation.Check my eligibility
What is being tested?
The MOTUS Total Joint Replacement procedure is being tested in patients requiring single-level lumbar spine joint replacement. The trial aims to show this new device is as safe and effective as traditional lumbar interbody fusion surgery using composite endpoints to measure outcomes.See study design
What are the potential side effects?
While specific side effects are not listed for the MOTUS device, similar surgical procedures may cause pain at the site of operation, infection risk, possible nerve damage leading to numbness or weakness in legs or back area complications related to anesthesia used during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have spinal issues like disc or annular degeneration, or lumbar stenosis.
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I have bone spurs in my spine.
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My back pain severely limits my daily activities.
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I have lower back pain due to lumbar spine issues confirmed by imaging, with minimal spine slippage.
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I have scarring or thickening in parts of my spine.
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I have been diagnosed with lumbar stenosis.
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I am between 21 and 80 years old and expected to live at least 3 more years.
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I have a herniated disc.
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I have tried all basic treatments for my condition for 3 months or I have a nerve emergency.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurological Status
Oswestry Disability Index (ODI) Score
Secondary Surgical Intervention (SSI)
+1 moreSecondary outcome measures
ODI
Radiographically confirmed subsidence
VAS
+2 moreOther outcome measures
Demographics
Intra-Operative Variables
Patient-Reported Outcomes Measurement Information System (PROMIS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MOTUSExperimental Treatment1 Intervention
All subjects will be treated with the MOTUS Total Joint Replacement
Find a Location
Who is running the clinical trial?
3SpineLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Lumbar Spine Degeneration
200 Patients Enrolled for Lumbar Spine Degeneration
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spine condition involves a vertebra slipping more than 25% over another.I have spinal issues like disc or annular degeneration, or lumbar stenosis.I have a spinal bone that cannot be moved.I have had deep vein thrombosis or blood clot issues before.I have bone spurs in my spine.I am not on medication that affects bone/soft tissue healing or undergoing long-term radiation.Your body mass index (BMI) is higher than 40.My back pain severely limits my daily activities.I have lower back pain due to lumbar spine issues confirmed by imaging, with minimal spine slippage.I have scarring or thickening in parts of my spine.I have arthritis in my spine.You are currently smoking cigarettes or using any tobacco products, including e-cigarettes (vaping).I have not been in a drug or device trial in the last 30 days and won't join one for 2 years.I have been diagnosed with lumbar stenosis.I have back pain without a known cause and no leg pain.I have a twisted spine curvature at a specific spine level.I am between 21 and 80 years old and expected to live at least 3 more years.I have a birth defect in my bones or spinal cord.I have a condition like Paget's disease that affects bone formation.I have a systemic disease like Lupus or HIV that needs drugs to lower my immune system.You have a high score on the Waddell Signs of Inorganic Behavior test.I have a herniated disc.I do not have conditions like Parkinson's, ALS, or multiple sclerosis that would affect the study's outcome evaluation.I have tried all basic treatments for my condition for 3 months or I have a nerve emergency.I have a curve in my upper back spine of 15 degrees or more.I need treatment for more than one level of my spine.I have had spine surgery with hardware at or near the level of my current back problem.I have a tumor in my spine.I have been cancer-free for 5 years, except for non-melanoma skin cancer.I use insulin to manage my diabetes.I have disc or annular degeneration.I'm sorry, but the criterion you provided seems to be incomplete. Could you please provide the complete criterion so I can rewrite it for you?I have had a spinal injury that hasn't healed properly.You have a defect in the lower part of your spine that affects its structure.You are allergic to certain metals (cobalt, chromium, molybdenum, nickel), certain materials (polyethylene, titanium), or vitamin E.I have severe spine issues at a specific spot.My spine's front ligament is damaged at a specific spot.I do not have any ongoing infections.I have current or past kidney or liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: MOTUS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for participants in this research trial?
"Affirmative. The data available on clinicaltrials.gov reveals that this research, which was first posted in June of 2022, is currently enrolling participants. Approximately 158 individuals must be recruited from two separate medical centres."
Answered by AI
What purpose does this experiment strive to accomplish?
"Over the course of two years, researchers will measure several primary and secondary outcomes. The main outcome to be evaluated is Secondary Surgical Intervention (SSI). Other indicators include Mean change in back VAS over time intervals, Visual Analog Score (VAS) - Worst Leg improvement at 24 months compared to baseline, and Radiographically confirmed subsidence regarding Absence of radiographically confirmed subsidence >5mm."
Answered by AI
What criteria must be met to join this research study?
"This medical trial is open to 158 individuals between the age of 21 and 80 who have suffered from lumbar spine degeneration. Additional eligibility criteria include disc degeneration, annular degeneration, spinal cord or nerve root compression, herniated nucleus pulposus, scarring/thickening of ligamentum flavum or facet joint capsule, spondylosis (characterised by osteophytes), preoperative Oswestry Disability Index score > 40/100 at baseline with a minimum 3 years life expectancy. Furthermore applicants must be psychologically stable and willing to comply with protocol requirements such as follow-up visits and form completion in"
Answered by AI
What is the most significant participant intake for this research trial?
"Indeed, the clinicaltrials.gov database reveals that this medical trial is actively recruiting participants as of October 11th 2022. The study was originally posted on June 20th and requires 158 patients to be enrolled from 2 different sites."
Answered by AI
Are applicants for this trial required to be of a certain age?
"Participants for this trial must be over 21 and under 80 years old."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
How old are they?
65+
What site did they apply to?
Center for Sports Medicine and Orthopaedics
Orthopaedic Institute of Western Kentucky
Oklahoma Spine Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Spinal injections and burning the nerves only provides a few weeks of.
PatientReceived 2+ prior treatments
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