Lumbar Spine DegenerationNCT04823858
3Spine Lumbar Fusion Real World Evidence Study
An observational study of Lumbar Spine Degeneration, run by 3Spine at 20 sites in United States.
Trial summary
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with… 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?
- Lumbar Interbody Fusion
- Type of treatment
- Medical device
- How many people
- 176 participants
- Where
- 20 sitesUnited States
- Study dates
- 25 May 2021to 15 Nov 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: Subjects participating in this study will be recruited from the investigators' standard patient populations. Only patients who plan to undergo an Open or Mini-Open TLIF or PLIF procedure independent of this research protocol, are considered for study.
Who may be able to join
- Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
- Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
- Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol;
- 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;
Show all 14Show fewer
- 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.
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 index 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 suited for a different course of treatment;
- Subcaudal defect, disrupting the integrity of the pedicle that presents undue risk of device subsidence or migration due to compromised bone quality/density;
Show all 42Show fewer
- 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 a 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
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of Colorado
Aurora, Colorado, 80045
The Spine Center of Louisiana
Baton Rouge, Louisiana, 70809
Todd Lanman MD, Inc.
Beverly Hills, California, 90210
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28204
Center for Sports Medicine and Orthopaedics
Chattanooga, Tennessee, 37404
Spine & Orthopedic Center
Deerfield Beach, Florida, 33441
Upstate Orthopedics
East Syracuse, New York, 13057
Vertrae Surgery Center
Miamisburg, Ohio, 45342
OrthoNeuro
New Albany, Ohio, 43054
NYU Langone, Spine Research Center
New York, New York, 10016
Oklahoma Center for Spine & Pain Solutions
Oklahoma City, Oklahoma, 73170
Strenge Spine Center
Paducah, Kentucky, 42003
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Mayo Clinic
Rochester, Minnesota, 55905
Ortho San Antonio
San Antonio, Texas, 78299
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
The Disc Replacement Center
South Jordan, Utah, 84088
Steamboat Orthopedics and Spine Institute (SOSI)
Steamboat Springs, Colorado, 80487
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
About this study
Official title: A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).
Read the detailed description
A prospective, multi-center (up to 20), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system).
An estimated 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.
- Conditions
- Lumbar Spine Degeneration
- Being tested
- Lumbar Interbody Fusion
- Keywords
- Posterior lumbar interbody fusion, Transforaminal lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Interbody FusionDevice
The TLIF/PLIF system includes a TLIF/PLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF/PLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study.
| Study group | Role | What they receive |
|---|---|---|
| Examination Group | There will only be one arm of subjects in this study. The arm will include subjects who plan to undergo a single-level TLIF/PLIF stabilized with pedicle screws and meet all of the eligibility criteria. Receives: Device: Lumbar Interbody Fusion |
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
Maintenance or improvement in neurological status at 24 months compared to baseline, as adjudicated by CEC. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.
Measured: 24 months compared to baseline
Secondary surgical intervention (SSI)
No subsequent surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level
Measured: 24 months
Serious device-related adverse events (SDAE)
Absence of serious device-related adverse events at 24 months, as adjudicated by the CEC (SDAE) (SDAE are events whose relationship is determined to be possibly related, probably related, or definitely related)
Measured: 24 months
Secondary outcomes (7)
Visual Analog Score (VAS) - Worst Leg
Improvement in VAS - Worst leg of 20mm at 24 months compared to baseline. The VAS is a measurement instrument that measures the amount of pain that a subject feels ranges across a continuum from none to an extreme amount of pain.
Measured: 24 months compared to baseline
VAS - Back
Improvement in VAS - Back pain of 20mm at 24 months compared to baseline
Measured: 24 months compared to baseline
ODI
Improvement in ODI of 15 points at 24 months compared to baseline
Measured: 24 months compared to baseline
ODI
Mean change in ODI over time intervals
Measured: 24 months compared to baseline
VAS
Mean change in leg VAS over time intervals
Measured: 24 months compared to baseline
VAS
Mean change in back VAS over time intervals
Measured: 24 months compared to baseline
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 posted1 Apr 2021
- Study start25 May 2021
- Primary completion23 Dec 2025
- Study completion15 Nov 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- 3Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MCRA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823858
- Sponsor's protocol ID
- 3Spine Lumbar Fusion Study
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2021
- Last updated
- 30 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 date collected 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Data Collection Study of Patients Treated With a Single-Level Lumbar Interbody Fusion Stabilized With Pedicle Screws
- ClinicalTrials.gov ID
- NCT04823858
- Acronym / sponsor ID
- 3Spine Lumbar Fusion Study
- Conditions
- Lumbar Spine Degeneration
- Keywords
- Posterior lumbar interbody fusion, Transforaminal lumbar interbody fusion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (actual)
- Lead sponsor
- 3SpineIndustry (pharma, biotech, devices)
- Collaborators
- MCRA
- Study start
- 25 May 2021 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 15 Nov 2029 (estimated)
- First posted
- 1 Apr 2021 (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 real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) instrumented with pedicle screws, using the framework of a prospective clinical study (with defined enrollment criteria and pre-specified research follow-up timepoints).
Detailed description
A prospective, multi-center (up to 20), non-blinded study of patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF) stabilized with pedicle screws. Investigators will only select those patients who are planned for treatment with on-label use of FDA cleared TLIF/PLIF devices (cage and screw system).
An estimated 200 subjects with a potential sample size re-estimation at completion. The subjects will return for follow-up at 6-weeks, 3-months, 6-months, and then annually for 5-years post surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Examination Group | – | Device: Lumbar Interbody FusionThere will only be one arm of subjects in this study. The arm will include subjects who plan to undergo a single-level TLIF/PLIF stabilized with pedicle screws and meet all of the eligibility criteria. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects participating in this study will be recruited from the investigators' standard patient populations. Only patients who plan to undergo an Open or Mini-Open TLIF or PLIF procedure independent of this research protocol, are considered for study.
Key inclusion criteria (14 listed)
- Male or female, age 21-80 (inclusive) with at least 3 years of life expectancy;
- Subject plans to undergo a one-level Open or Mini-Open TLIF or PLIF procedure (stabilized with pedicle screws) independent of this research protocol;
- Subject is to be treated with on-label use of an FDA-cleared TLIF or PLIF cage(s) and pedicle screw system independent of this research protocol;
- 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;
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 index 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 suited for a different course of treatment;
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 |
|---|---|---|
| Lumbar Interbody FusionThe TLIF/PLIF system includes a TLIF/PLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF/PLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study. | Device | Examination Group |
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
Maintenance or improvement in neurological status at 24 months compared to baseline, as adjudicated by CEC. Neurological examination will consist of a motor and sensory examination at each in person study visit conducted per physician standard of care.
Secondary surgical intervention (SSI)
Time frame: 24 months
No subsequent surgical intervention including revision, re-operation, removal, or supplemental fixation at the index level
Serious device-related adverse events (SDAE)
Time frame: 24 months
Absence of serious device-related adverse events at 24 months, as adjudicated by the CEC (SDAE) (SDAE are events whose relationship is determined to be possibly related, probably related, or definitely related)
7 secondary outcomes
Visual Analog Score (VAS) - Worst Leg
Time frame: 24 months compared to baseline
VAS - Back
Time frame: 24 months compared to baseline
ODI
Time frame: 24 months compared to baseline
ODI
Time frame: 24 months compared to baseline
VAS
Time frame: 24 months compared to baseline
VAS
Time frame: 24 months compared to baseline
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 30 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 date collected 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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Degeneration, run by 3Spine at 20 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 14 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 30 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 20 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 NCT04823858, 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 30 Jun 2026.