MOTUS Total Joint Replacement Investigational Device Exemption Study

NCT05438719 | Active Not Recruiting FDA Device

• 1 other identifier: MOTUS IDE
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Lumbar Spine Degeneration

Keywords

MOTUS

Outcome Measures

Primary Outcomes (4)

• Oswestry Disability Index (ODI) Score

  Improvement of at least 15 points in ODI score (out of 100). The ODI is a self-reported questionnaire that contains ten sections concerning intensity of pain, lifting, personal care, walking, sitting, sexual function, standing, social life, sleeping and traveling.

  24 months compared to baseline

• Neurological Status

  Absence of deterioration in neurological status compared to baseline examinations. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care. These data will be adjudicated by the Clinical Events Committee (CEC).

  24 months compared to baseline

• Subsequent Surgical Intervention (SSI)

  Subject success will be determined with the absence of a subsequent surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level.

  24 month

• Serious device-related adverse events (SDAE)

  Subject success will be determined with the absence of any serious device-related adverse events (SDAE). These data will be adjudicated by the Clinical Events Committee (CEC).

  24 month

Secondary Outcomes (7)

• Visual Analog Score (VAS) - Worst Leg

  24 months

• VAS - Back

  24 months

• ODI

  24 months

• ODI

  24 months

• VAS

  24 months

Other Outcomes (3)

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  24 months

• Demographics and Intra-operative variables

  24 months

• Time to first SSI

  24 months

Study Arms (1)

MOTUS

EXPERIMENTAL

All subjects will be treated with the MOTUS Total Joint Replacement

Device: MOTUS Total Joint Replacement

Interventions

MOTUS Total Joint Replacement DEVICE

The MOTUS Total Joint Replacement is indicated for the biomechanical reconstruction and stabilization of a spinal motion segment following decompression at one lumbar level from L1/L2 to L5/S1 for skeletally mature patients due to symptomatic lumbar degeneration with or without foraminal or recess spinal stenosis confirmed by radiographic imaging (CT, MRI, X-rays), with no more than a Grade 1 spondylolisthesis at the involved level.

MOTUS

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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; and
• Signed informed consent.

You may not qualify if:

• More than one vertebral level requiring treatment with instrumentation;
• Previous instrumented surgery (i.e.: anterior disc replacement, spinal fusion, interspinous device, etc.) at the index lumbar level or an adjacent level;
• Degenerative or lytic spondylolisthesis greater than Grade 1 (25% translation) associated with congenital (e.g. dysplastic) pars defects;
• Rotatory scoliosis (\>10 degrees) at the index level;
• Congenital bony and/or spinal cord abnormalities at the level to be treated such as conjoined nerve roots that would otherwise prevent placement of the device without generating nerve damage or skeletal malformations such as kyphotic vertebra that may be better suited for a different course of treatment (e.g. spinal fusion);
• Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density;
• Clinically compromised vertebral bodies at the index level due to current or past trauma, e.g., by the radiographic appearance of the fracture callus, malunion or nonunion;
• Disrupted anterior longitudinal ligament at the index level;
• Overlying thoracolumbar kyphosis (greater than or equal to 15 degrees) within one level (includes target and adjacent level) of the level to be treated;
• Back pain of unknown etiology without leg pain;
• Severe spondylosis at the level to be treated as characterized by any of the following:
• Autofusion (solid arthrodesis) determined radiographically (CT);
• Totally collapsed disc, or;
• Vertebral body that cannot be mobilized;
• Known allergy to cobalt, chromium, molybdenum, nickel, polyethylene, titanium, or vitamin E;

Sponsors & Collaborators

• 3Spine: lead

Study Sites (14)

Todd H. Lanman, MD Inc.

Los Angeles, California, 90210, United States

Location

Steamboat Orthopaedic & Spine Institute (SOSI)

Steamboat Springs, Colorado, 80487, United States

Location

Spine and Orthopedic Center

Deerfield Beach, Florida, 33441, United States

Location

Florida Orthopaedic Institute

Temple Terrace, Florida, 33637, United States

Location

Strenge Spine Centert

Paducah, Kentucky, 42003, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Pinehurst Surgical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Oklahoma Spine Center

Oklahoma City, Oklahoma, 73170, United States

Location

Center for Sports Medicine and Orthopaedics

Chattanooga, Tennessee, 37404, United States

Location

Ortho San Antonio

San Antonio, Texas, 78229, United States

Location

The Disc Replacement Center

West Jordan, Utah, 84088, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 30, 2022
• Study Start: June 23, 2022
• Primary Completion: February 9, 2026
• Study Completion (Estimated): June 13, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)