MOTUS Device for Lumbar Spine Degeneration

Not currently recruiting at 14 trial locations

Overseen By Kevin McGinnis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 3Spine

Must not be taking: Immunosuppressants, Biologics, Radiation therapy

Disqualifiers: Diabetes, Osteopenia, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

I have spinal issues like disc or annular degeneration, or lumbar stenosis.

I have bone spurs in my spine.

My back pain severely limits my daily activities.

Exclusion Criteria

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

I have a spinal bone that cannot be moved.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the MOTUS Total Joint Replacement procedure

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits (in-person) as per physician standard of care

What Are the Treatments Tested in This Trial?

Interventions

• BalancedBack Total Joint Replacement

Trial Overview

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.

How Is the Trial Designed?

Group I: MOTUS Experimental Treatment 1 Intervention

All subjects will be treated with the MOTUS Total Joint Replacement

Who Is Running the Clinical Trial?

3Spine

Lead Sponsor

Trials

2

Recruited

330+

Citations

1.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05438719/motus-total-joint-replacement-investigational-device-exemption-study

MOTUS Total Joint Replacement Investigational Device ...

This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the ...

2.

3spine.com

3spine.com/

3Spine: Total Joint Replacement for the Lumbar Spine

Long-Term Clinical Outcomes With the Activ-L Lumbar Arthroplasty ... A novel lumbar total joint replacement may be an improvement over fusion for degenerative ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05438719

MOTUS Total Joint Replacement Investigational Device ...

This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11467273/

Total joint replacement of the lumbar spine - PubMed Central

A novel lumbar total joint replacement may be an improvement over fusion for degenerative lumbar conditions: a comparative analysis of ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S152994302031250X

A novel lumbar total joint replacement may be an ...

A novel lumbar total joint replacement may be an improvement over fusion for degenerative lumbar conditions: a comparative analysis of patient-reported ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666548425001672

24-month patient-reported outcomes for a novel lumbar ...

TLIF stands as a historical mainstay for the treatment of many degenerative lumbar diseases [22]. Lumbar fusion has traditionally enabled a wide neural ...

7.

tandfonline.com

tandfonline.com/doi/full/10.1080/17434440.2025.2484252

Optimizing the clinical adoption of total joint replacement ...

TJR represents a groundbreaking innovation with respect to how we approach degenerative lumbar conditions, and it has the potential to positively impact the ...

8.

withpower.com

withpower.com/trial/phase-lumbar-spine-degeneration-5-2022-95549

MOTUS Device for Lumbar Spine Degeneration

The MOTUS Device for Lumbar Spine Degeneration, using the BalancedBack Total Joint Replacement, is unique because it aims to preserve motion in the spine, ...

9.

researchgate.net

researchgate.net/publication/396758224_Total_Joint_Replacement_of_the_Lumbar_Spine_12-Month_Pain_and_Functional_Outcomes_From_an_Investigational_Device_Exemption_Clinical_Trial

Total Joint Replacement of the Lumbar Spine

... degenerative lumbar conditions: a comparative analysis of patient-reported outcomes at one year. Jan 2021; 336-342. Alex Sielatycki; J Devin ...