BalancedBack Total Joint Replacement for Lumbar Spine Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center for Sports Medicine and Orthopaedics, Chattanooga, TN
Lumbar Spine Degeneration
BalancedBack Total Joint Replacement - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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 MOTUS device (BalancedBack Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.

Treatment Effectiveness

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 24 month

24 month
Secondary Surgical Intervention (SSI)
Serious device-related adverse events (SDAE)
24 months
Demographics
Intra-Operative Variables
ODI
Patient-Reported Outcomes Measurement Information System (PROMIS)
Radiographically confirmed subsidence
Time to first SSI
VAS
VAS - Back
Visual Analog Score (VAS) - Worst Leg
Month 24
Neurological Status
Oswestry Disability Index (ODI) Score

Trial Safety

Trial Design

1 Treatment Group

BalancedBack
1 of 1
Experimental Treatment

158 Total Participants · 1 Treatment Group

Primary Treatment: BalancedBack Total Joint Replacement · No Placebo Group · N/A

BalancedBack
Device
Experimental Group · 1 Intervention: BalancedBack Total Joint Replacement · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 month
Closest Location: Center for Sports Medicine and Orthopaedics · Chattanooga, TN
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N/AFirst Recorded Clinical Trial
2 TrialsResearching Lumbar Spine Degeneration
0 CompletedClinical Trials

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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have degenerative disc disease or lumbar stenosis defined by spinal cord or nerve root compression.
You have facet joint degeneration/osteophyte formation.
You have an Oswestry Disability Index score of 40 or more at baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.