MOTUS Device for Lumbar Spine Degeneration

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

158 Participants Needed

Trial Summary

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 data supports the effectiveness of the BalancedBack Total Joint Replacement treatment for lumbar spine degeneration?

The long-term study of an interspinous stabilization system, similar to the BalancedBack treatment, showed promising results in maintaining spine stability and reducing the need for further surgeries, suggesting potential effectiveness in treating lumbar spine degeneration. ^{1 2 3 4 5}

Is the MOTUS Device for Lumbar Spine Degeneration safe for humans?

The long-term safety of a similar interspinous stabilization system, which aims to stabilize the spine while preserving some movement, has been supported by a study showing that most patients did not need further surgery or device removal over 14 years. This suggests that the device is generally safe for human use. ^{3 5 6 7 8}

How is the MOTUS Device for Lumbar Spine Degeneration treatment different from other treatments?

The MOTUS Device for Lumbar Spine Degeneration, using the BalancedBack Total Joint Replacement, is unique because it aims to preserve motion in the spine, unlike traditional fusion surgeries that limit movement. This approach is similar to total disc arthroplasty, which also maintains spinal flexibility, potentially reducing stress on adjacent spinal segments. ^{2 3 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Impact of surgery on pain, disability, and quality of life of patients with degenerative lumbar disease: Brazilian data. [2020]

2. Turkey pubmed.ncbi.nlm.nih.gov

Experience with the second-generation Wallis interspinous dynamic stabilization device implanted in degenerative lumbar disease: a case series of 50 patients. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Long-term Results for the BacJac Interspinous Device in Lumbar Spine Degenerative Disease. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Lumbar degenerative disease after oblique lateral interbody fusion: sagittal spinopelvic alignment and its impact on low back pain. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Long-term actuarial survivorship analysis of an interspinous stabilization system. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The relationship of pelvic incidence to post-operative total hip arthroplasty dislocation in patients with lumbar fusion. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Effect of total hip replacement on lumbago in unilateral developmental hip dysplasia]. [2008]

8. England pubmed.ncbi.nlm.nih.gov

How much does lumbar fusion change sagittal pelvic tilt in individuals receiving total hip arthroplasty? [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Total disc replacement positioning affects facet contact forces and vertebral body strains. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Maverick total disc arthroplasty performs well at 10 years follow-up: a prospective study with HRQL and balance analysis. [2022]