What side effects are associated with this type of intervention?

Common treatments for Lumbar Spine Degeneration, such as lumbar interbody fusion and vertebroplasty, have several known side effects. Lumbar interbody fusion can lead to complications like infection, nerve damage, blood clots, and issues related to the hardware used in the procedure. Vertebroplasty, while generally effective for pain relief, can cause cement leakage, which may lead to nerve damage or pulmonary embolism. Both procedures carry risks of anesthesia-related complications and postoperative pain. The MOTUS device, being a total joint replacement, may share similar risks, including infection, implant failure, and adjacent segment degeneration.

What prior FDA approvals exist?

The FDA has approved several treatments for Lumbar Spine Degeneration, primarily focusing on surgical interventions such as lumbar interbody fusion. This procedure involves the removal of a degenerated disc and the fusion of adjacent vertebrae to stabilize the spine. Other related treatments include various spinal implants and devices designed to support spinal stability and alleviate pain. While specific FDA approvals for total joint replacement of the lumbar spine, like the MOTUS device, are less common, these surgical approaches aim to address similar issues of spinal degeneration and instability.

What other types of research exist?

Promising, novel alternatives to the MOTUS device for lumbar spine degeneration include the Kineflex lumbar artificial disc and the Charité lumbar total disc replacement. Both devices have been evaluated for safety and efficacy in treating degenerative disc disease.

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Total Joint Replacement

MOTUS Device for Lumbar Spine Degeneration

N/A

Waitlist Available

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)

Must not have

Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation)

Vertebral body that cannot be mobilized

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called MOTUS to replace a damaged joint in the lower back. It aims to help patients who need a single-level joint replacement move better and feel less pain.

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.

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.

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 below

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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.

Exclusion Criteria

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

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My spine condition involves a vertebra slipping more than 25% over another.

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I have a spinal bone that cannot be moved.

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I have had deep vein thrombosis or blood clot issues before.

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I am not on medication that affects bone/soft tissue healing or undergoing long-term radiation.

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I have back pain without a known cause and no leg pain.

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I have a twisted spine curvature at a specific spine level.

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I have a birth defect in my bones or spinal cord.

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I have a condition like Paget's disease that affects bone formation.

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I have a systemic disease like Lupus or HIV that needs drugs to lower my immune system.

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I do not have conditions like Parkinson's, ALS, or multiple sclerosis that would affect the study's outcome evaluation.

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I have a curve in my upper back spine of 15 degrees or more.

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I need treatment for more than one level of my spine.

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I have had spine surgery with hardware at or near the level of my current back problem.

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I have a tumor in my spine.

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I use insulin to manage my diabetes.

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I have had a spinal injury that hasn't healed properly.

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I have severe spine issues at a specific spot.

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My spine's front ligament is damaged at a specific spot.

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I do not have any ongoing infections.

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I have current or past kidney or liver disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neurological Status

Oswestry Disability Index (ODI) Score

Secondary Surgical Intervention (SSI)

+1 more

Secondary study objectives

ODI

Radiographically confirmed subsidence

VAS

+2 more

Other study objectives

Demographics

Intra-Operative Variables

Patient-Reported Outcomes Measurement Information System (PROMIS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MOTUSExperimental Treatment1 Intervention

All subjects will be treated with the MOTUS Total Joint Replacement

0 / 29Eligibility 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

The most common treatments for Lumbar Spine Degeneration, such as total joint replacement (e.g., MOTUS device), lumbar interbody fusion, vertebroplasty, and kyphoplasty, primarily aim to stabilize the spine and alleviate pain. Total joint replacement involves replacing the degenerated joint with an artificial one, which helps restore mobility and reduce pain by mimicking the natural movement of the spine. Lumbar interbody fusion stabilizes the spine by fusing two or more vertebrae together, which reduces motion at the degenerated segment and alleviates pain. Vertebroplasty and kyphoplasty involve injecting bone cement into the vertebrae to stabilize fractures and reduce pain. These treatments are crucial for patients with Lumbar Spine Degeneration as they address the underlying structural issues, thereby improving function and quality of life.

Regenerative Techniques for Neuraxial Back Pain: a Systematic Review.Methodology in clinical back pain trials.