An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement

Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 (MOTUS Total Joint Replacement procedure) to demonstrate noninferiority to lumbar interbody fusion with respect to composite endpoints.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy

• The subject has a primary diagnosis of symptomatic lumbar degeneration with or without foraminal or recess stenosis of the lumbar spine at a single level from L1/L2 to L5/S1 confirmed by subject history and radiographic imaging (CT, MRI, X- rays) with no more than a Grade 1 (\<25% translation) spondylolisthesis. Symptomatic lumbar degeneration that may be associated with a co-morbid condition such as:

‣ Herniated nucleus pulposus

⁃ Scarring/thickening of the ligamentum flavum, annulus fibrosus, or facet joint capsule

⁃ Facet joint degeneration/osteophyte formation

⁃ Spondylosis (defined by the presence of osteophytes)

⁃ Disc degeneration and/or annular degeneration; and/or

⁃ Lumbar stenosis defined by spinal cord or nerve root compression

• Exhausted conservative treatment (e.g. bed rest, physical therapy, medications, TENS (transcutaneous electrical nerve stimulation), manipulation, and/or spinal injections) for at least 3 months or has a neurologic emergency

• Preoperative Oswestry Disability Index score ≥ 40/100 at baseline

• Psychosocially, mentally, and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms

• Signed informed consent.

Locations
United States
California
Todd H. Lanman, MD Inc.
Los Angeles
Colorado
Steamboat Orthopaedic & Spine Institute (SOSI)
Steamboat Springs
Florida
Spine an Orthopedic Center
Deerfield Beach
Florida Orthopaedic Institute
Temple Terrace
Kentucky
Strenge Spine Institute
Paducah
Louisiana
Spine Institute of Louisiana
Shreveport
Minnesota
Mayo Clinic
Rochester
North Carolina
Pinehurst Surgical Clinic
Pinehurst
New York
Upstate Ortho
East Syracuse
NYU Langone
New York
Oklahoma
Oklahoma Spine Center
Oklahoma City
Tennessee
Center for Sports Medicine and Orthopaedics
Chattanooga
Texas
Orthopedic San Antonio
San Antonio
Utah
The Disc Replacement Center
West Jordan
Time Frame
Start Date: 2022-06-23
Completion Date: 2029-06-13
Participants
Target number of participants: 158
Treatments
Experimental: MOTUS
All subjects will be treated with the MOTUS Total Joint Replacement
Related Therapeutic Areas
Sponsors
Leads: 3Spine

This content was sourced from clinicaltrials.gov