Lumbar Spine DegenerationNCT05438719
MOTUS Total Joint Replacement Investigational Device Exemption Study
A study testing MOTUS Total Joint Replacement in people with Lumbar Spine Degeneration, run by 3Spine at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lumbar Spine Degeneration
- What is being tested?
- MOTUS Total Joint Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 14 sitesUnited States
- Study dates
- 23 Jun 2022to 13 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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;
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- 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;
- Unable to undergo an MRI scan, CT scan or other radiograph assessments;
- Osteopenia diagnosed by surgeon using a comprehensive assessment of all available information including the following:
- DEXA bone density measured T-score ≤ -1:
- Females age <50 and males age <55: The SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required.
- Females age ≥50 and all males age ≥55: DEXA scan is required.
- If indicated for DEXA, an existing scan is allowed if completed within 6 months of subject surgery;
- Opportunistic quantitative CT (Hounsfield Units): Measurement is encouraged as supplemental information to determine potential for osteopenia;
- Intra-operative evaluation of bone quality to assess if there is a significant risk for implant subsidence;
- Has history of any endocrine or metabolic disorder known to affect osteogenesis (e.g.: Paget's disease, renal osteodystrophy, Ehler-Danlos syndrome, or osteogenesis imperfecta);
- Insulin-dependent diabetes mellitus;
- Lactating, pregnant or interested in becoming pregnant in the next 3 years;
- Active infection - systemic or local;
- Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study;
- Body Mass Index > 40;
- Recurrent history of deep vein thrombosis, symptoms of arterial insufficiency, or thromboembolic disease;
- Systemic disease including Lupus disease, Reiter's disease, Rheumatoid disease, AIDS, HIV, hepatitis or autoimmune disease that requires immunosuppressive therapy, including biologics, for systemic inflammation;
- Spinal tumor at the index level or adjacent level that could compromise integrity of the implant (hemangiomas must be evaluated by the investigator and determined to not be pathologic, for example a biopsy may be required;
- Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
- Any degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis;
- Has chronic or acute renal and/or hepatic impairment and/or failure or prior history of renal and/or hepatic parenchymal disease;
- Has a Waddell Signs of Inorganic Behavior score of 3 or greater;
- In the opinion of the investigator, the subject has a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device;
- Current or recent history of chemical/alcohol abuse or dependency using standard medical definition of DSM-5 code;
- Currently smoking or using tobacco products, including e-cigarette products (e.g., vaping) (Use within 30 days of surgery date is considered 'current');
- Currently pursuing or in active spinal litigation for medical negligence, or trauma, or workers compensation;
- Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results;
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 24 months following enrollment into the study.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Center for Sports Medicine and Orthopaedics
Chattanooga, Tennessee, 37404
Spine and Orthopedic Center
Deerfield Beach, Florida, 33441
Upstate Orthopedics
East Syracuse, New York, 13057
Todd H. Lanman, MD Inc.
Los Angeles, California, 90210
NYU Langone
New York, New York, 10016
Oklahoma Spine Center
Oklahoma City, Oklahoma, 73170
Strenge Spine Centert
Paducah, Kentucky, 42003
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Mayo Clinic
Rochester, Minnesota, 55905
Ortho San Antonio
San Antonio, Texas, 78229
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Steamboat Orthopaedic & Spine Institute (SOSI)
Steamboat Springs, Colorado, 80487
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
The Disc Replacement Center
West Jordan, Utah, 84088
About this study
Official title: An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement
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.
Read the detailed description
A multi-center (up to 20 investigational sites), prospective, non-blinded investigation of the MOTUS Total Joint Replacement (TJR) device. These data will be compared to a lumbar interbody fusion (transforaminal lumbar interbody fusion [TLIF] or posterior lumbar interbody fusion [PLIF]) control group enrolled in a separate real world evidence (RWE) study. Balance between groups will be achieved through sub classification using propensity scores by a blinded statistician.
- Conditions
- Lumbar Spine Degeneration
- Being tested
- MOTUS Total Joint Replacement
- Keywords
- MOTUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTUS Total Joint ReplacementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MOTUS | Experimental | All subjects will be treated with the MOTUS Total Joint Replacement Receives: Device: MOTUS Total Joint Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 24 month
Secondary outcomes (7)
Visual Analog Score (VAS) - Worst Leg
Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline
Measured: 24 months
VAS - Back
Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
Measured: 24 months
ODI
Improvement in ODI of 15 points at 24 months compared to baseline
Measured: 24 months
ODI
Mean change in ODI over time intervals
Measured: 24 months
VAS
Mean change in leg VAS over time intervals
Measured: 24 months
VAS
Mean change in back VAS over time intervals
Measured: 24 months
Radiographically confirmed subsidence
Absence of radiographically confirmed subsidence >5mm
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start23 Jun 2022
- Primary completion9 Feb 2026
- Study completion13 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438719
- Sponsor's protocol ID
- MOTUS IDE
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This trial uses data for a motion-preserving spine implant for a US FDA regulated PMA application. These data are proprietary and thus access is managed accordingly with dissemination considered after completion of FDA review. Beyond providing clinical evidence for a PMA, we plan to share findings through peer-reviewed publications \& scientific presentations. Prior to public release, data is reviewed for consistency with protocol, informed consent, participant confidentiality \& regulatory requirements. Data is verified for accuracy \& completeness, including demographics, operative details, functional assessments \& PROMs. After FDA review, de-identified data will be available to qualified investigators upon request contingent upon sponsor approval, available budget, a signed data use agreement, compliance with HIPAA \& terms of patient informed consent. The sponsor shall review requests for scientific merit, requestor qualifications, patient consent alignment \& regulatory obligations.
Publications
Yarbrough RV, Spece H, Kurtz SM, Breno AJ, Maislin D. Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol. BMJ Open. 2026 Jul 21;16(7):e111764. doi: 10.1136/bmjopen-2025-111764.
PubMed 42481192
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Multi-center Investigation of the MOTUS Total Joint Replacement
- ClinicalTrials.gov ID
- NCT05438719
- Acronym / sponsor ID
- MOTUS IDE
- Conditions
- Lumbar Spine Degeneration
- Keywords
- MOTUS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (actual)
- Lead sponsor
- 3SpineIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 13 Jun 2029 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A multi-center (up to 20 investigational sites), prospective, non-blinded investigation of the MOTUS Total Joint Replacement (TJR) device. These data will be compared to a lumbar interbody fusion (transforaminal lumbar interbody fusion [TLIF] or posterior lumbar interbody fusion [PLIF]) control group enrolled in a separate real world evidence (RWE) study. Balance between groups will be achieved through sub classification using propensity scores by a blinded statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MOTUS | Experimental | Device: MOTUS Total Joint ReplacementAll subjects will be treated with the MOTUS Total Joint Replacement |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (42 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOTUS Total Joint ReplacementThe 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. | Device | MOTUS |
Primary outcome
Oswestry Disability Index (ODI) Score
Time frame: 24 months compared to baseline
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.
Neurological Status
Time frame: 24 months compared to baseline
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).
Subsequent Surgical Intervention (SSI)
Time frame: 24 month
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.
Serious device-related adverse events (SDAE)
Time frame: 24 month
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).
7 secondary outcomes
Visual Analog Score (VAS) - Worst Leg
Time frame: 24 months
VAS - Back
Time frame: 24 months
ODI
Time frame: 24 months
ODI
Time frame: 24 months
VAS
Time frame: 24 months
VAS
Time frame: 24 months
Radiographically confirmed subsidence
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Derived from this study: PubMed 42481192Yarbrough RV, Spece H, Kurtz SM, Breno AJ, Maislin D. Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol. BMJ Open. 2026 Jul 21;16(7):e111764. doi: 10.1136/bmjopen-2025-111764.
- Individual participant dataSharing planned: No. This trial uses data for a motion-preserving spine implant for a US FDA regulated PMA application. These data are proprietary and thus access is managed accordingly with dissemination considered after completion of FDA review. Beyond providing clinical evidence for a PMA, we plan to share findings through peer-reviewed publications \& scientific presentations. Prior to public release, data is reviewed for consistency with protocol, informed consent, participant confidentiality \& regulatory requirements. Data is verified for accuracy \& completeness, including demographics, operative details, functional assessments \& PROMs. After FDA review, de-identified data will be available to qualified investigators upon request contingent upon sponsor approval, available budget, a signed data use agreement, compliance with HIPAA \& terms of patient informed consent. The sponsor shall review requests for scientific merit, requestor qualifications, patient consent alignment \& regulatory obligations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTUS Total Joint Replacement in people with Lumbar Spine Degeneration, run by 3Spine at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) Score (time frame: 24 months compared to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.