MOTUS Device for Lumbar Spine Degeneration
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on testing a new treatment option called the MOTUS Total Joint Replacement for individuals with lumbar spine degeneration. The researchers aim to determine if this device is as effective as the standard procedure, lumbar interbody fusion, in relieving symptoms and improving daily life. It targets those who have struggled with severe back issues, such as disc degeneration or spinal stenosis, despite trying other treatments like physical therapy or spinal injections. Participants should be able to identify a single problematic area in their lower back and have experienced back pain and mobility issues for an extended period. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could enhance quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on any drugs that might interfere with bone or soft tissue healing, you may need to stop them. It's best to discuss your specific medications with the trial team.
What prior data suggests that the MOTUS device is safe for lumbar spine degeneration?
Research has shown that the MOTUS Total Joint Replacement, used for lower back issues, is generally well-tolerated. Previous studies examined patient outcomes after this procedure, and the results were encouraging. Specifically, participants reported less pain and improved movement up to a year post-treatment.
The device is designed to maintain the spine's natural movement, offering a significant benefit. Although detailed safety information is not always available, the MOTUS device is based on technology used in other spine surgeries, suggesting it is likely safe.
However, any medical procedure can carry risks. Prospective trial participants should consult a doctor to understand the potential benefits and risks.12345Why are researchers excited about this trial?
Researchers are excited about the BalancedBack Total Joint Replacement because it offers a novel approach to treating lumbar spine degeneration. Unlike traditional spinal fusion surgeries, which limit movement by permanently joining vertebrae, the BalancedBack system maintains natural spine motion. This device aims to reduce pain while preserving flexibility, which could lead to improved patient outcomes and a quicker return to daily activities. By focusing on restoring balance and movement in the spine, it represents a significant advancement over current surgical options.
What evidence suggests that the MOTUS device is effective for lumbar spine degeneration?
Research has shown that the BalancedBack Total Joint Replacement, known as the MOTUS device, might outperform traditional spinal fusion in treating lower back problems. Studies have found that this joint replacement can improve mobility and reduce pain. Patients who received the MOTUS device reported greater satisfaction compared to those who underwent fusion surgery. Early results also indicate that this device preserves the spine's natural movement, often restricted after fusion. These findings offer promising evidence of the MOTUS device's effectiveness for individuals with lower back degeneration.16789
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the MOTUS Total Joint Replacement procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BalancedBack Total Joint Replacement
Find a Clinic Near You
Who Is Running the Clinical Trial?
3Spine
Lead Sponsor