Degenerative Disc DiseaseNCT04911257
Interbody Systems: Post Market Clinical Follow-up Study
An observational study of Degenerative Disc Disease, run by K2M, Inc. at 4 sites in United States.
Trial summary
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Cervical or Lumbar Spinal fusion
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Dec 2021to 21 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study sample will include patients that present with on-label conditions that will be surgically treated by participating investigators.
Who may be able to join
- Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systems for on label indications, which are listed below as inclusion criteria.
- Diagnosed with degenerative disc disease (DDD).
- Please note for Lumbar devices:
- Can also be diagnosed with up to Grade 1 Spondylolisthesis and/or Degenerative Scoliosis. (Chesapeake is not indicated for degenerative scoliosis)
- Cascadia/Mojave/ Sahara/ Monterey AL can also be diagnosed with up to Grade 1 Retrolisthesis.
- Outside of USA, Tritanium is indicated for use in patients with diagnosis of Degenerative Spine Disorders, Spine Revision, Discal and Vertebral Instability; and there is no restriction to Spondylolisthesis Grade.
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- Willingness and ability to comply with the requirements of the protocol including follow up requirements.
- Willing and able to sign a study specific informed consent form.
- Skeletally mature (age at least 18 years) and:
- Have had six months of lumbar non operative therapy.
- Have had six weeks of cervical non operative treatment.
- Will undergo interbody fusion at one or two contiguous levels (Chesapeake Cervical Ti is only indicated for use at one level) at:
- L2 L5 for Cascadia lateral hyperlordotic (>22°l).
- L2 S1 for all other lumbar interbody systems.
- C2 T1 for cervical interbody systems.
- Self reports Oswestry Disability Index (ODI) score 30% (raw score of 15/50) for lumbar patients and Neck Disability Index (NDI) score 30% (raw score of 15/50) for cervical patients at pre operative visit.
Who cannot join
- Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
- For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
- For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified tissues.
- Biological factors such as smoking or using nonsteroidal anti inflammatory agents/ anticoagulants.
- Immunosuppressive disorders.
- Grossly distorted anatomy. N/A for Tritanium TL, Tritanium Cervical and Monterey AL
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- Inadequate tissue coverage or open wounds.
- Infection at index level(s) at the time of surgery.
- Patients with known sensitivity to materials in the device.
- Has a neuromuscular disorder or mental condition (including general neurological conditions, mental illness, senility, and drug/alcohol abuse) which would create an unacceptable risk of fixation failure or complications in postoperative care or willingness to restrict activities or follow medical advice.
- Obesity.
- Other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC) or marked left shift in the WBC differential count.
- For the Tritanium and Monterey AL systems: Any abnormality which affects the normal process of bone remodeling including, but not limited to severe osteoporosis involving the spine, bone absorption, osteopenia, primary or metastatic tumors involving the spine or certain metabolic disorders affecting osteogenesis.
- Please note for Tritanium cervical this also includes rapid joint disease, bone absorption, osteopenia, osteomalacia, and/or osteoporosis.
- For the Tritanium, Monterey AL, Chesapeake and Sahara systems: Prior fusion at the level to be treated (as indicated in the IFU).
- Pregnancy, or if the patient intends to become pregnant during the course of the study.
- Incarcerated at the time of study enrollment.
- Current participation in an investigational study that may impact study outcomes.
- Involved in current or pending litigation regarding a spine surgery.
- Receiving worker's compensation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Inova Neurosciences Research
Falls Church, Virginia, 22042
The Spine Clinic of Oklahoma City
Oklahoma City, Oklahoma, 73114
Spine Institute of Louisiana Foundation, Inc.
Shreveport, Louisiana, 71101
About this study
Official title: Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).
The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 < -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.
- Conditions
- Degenerative Disc Disease
- Being tested
- Cervical or Lumbar Spinal fusion
- Keywords
- Spondylolisthesis, Degenerative Scoliosis, Retrolisthesis.
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical or Lumbar Spinal fusionDevice
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.
| Study group | Role | What they receive |
|---|---|---|
| Degenerate Disc Disease | Subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems. Receives: Device: Cervical or Lumbar Spinal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Oswestry Disability Index Change
Oswestry Disability Index (ODI) (lumbar) improvement from baseline to 12 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.
Measured: 12 Months
Mean Neck Disability Index Change
Neck Disability Index (NDI) (cervical) improvement from baseline to 12 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.
Measured: 12 Months
Secondary outcomes (15)
Mean Oswestry Disability Index Change
Oswestry Disability Index (ODI) (lumbar) change from baseline to 24 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.
Measured: 24 Months
Mean Neck Disability Index Change
Neck Disability Index (NDI) (cervical) change from baseline to 24 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.
Measured: 24 months
Safety Events
The following safety events will be collected through 24 months, including the following: (MedDRA will be used to define these events)
- Serious adverse events
- Device-related adverse events
- Procedure-related adverse events
- Operative site adverse events
- Secondary spine surgeries (secondary interventions)
- Adverse event that negatively impacts the primary endpoint
Measured: 24 months
Fusion Status
Fusion will be derived from a logical analysis of three component factors: angular motion, translational motion, and bridging bone. Each treated level must be considered fused in order for the subject to be considered a radiographic success.
Measured: 3, 6, 12 and 24 months
Angular Motion
Angular Motion will be measured from lateral flexion-extension radiographs. Angular motion, also known as rotation, is defined as the change in angle between the adjacent endplates of the motion segment. Angular Motion will be reported in units of degrees
Measured: 3, 6, 12 and 24 months
Translational Motion
Translational Motion will be measured from lateral flexion-extension radiographs Translational motion is defined as the displacement of the posterior-inferior corner of the superior vertebra in a direction defined parallel to the superior endplate of the inferior vertebra. Translational Motion - Cervical will be reported in units of millimeters and percentage (%) of the anteroposterior (AP) length of the superior endplate of the inferior vertebra.
Measured: 3, 6, 12 and 24 months
Bridging Bone
Interbody Bridging Bone will be graded in accordance with the following definitions:
- Absent: No evidence of continuous bridging bone from endplate to endplate.
- Present: Presence of continuous bridging bone from endplate to endplate.
Measured: 3, 6, 12 and 24 months
Disc Height
Disc Height will be calculated from neutral lateral radiographs. Disc Height will be reported in units of millimeters and percentage (%) of the AP length of the superior endplate of the inferior vertebra. Average Disc Height
Measured: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Device Migration
Migration will be assessed relative to the Week 2 time point or earliest available post-operative visit. Migration will be measured in millimeters.
Measured: 6 weeks, 3, 6, 12 and 24 months
Subsidence
Subsidence will be assessed relative to the Week 2 time point or earliest available post-operative visit, Subsidence will be measured in millimeters.
Measured: 6 weeks, 3, 6, 12 and 24 months
Adjacent Segment Degeneration
Adjacent Segment Degeneration will be assessed at the adjacent levels using the Kellgren-Lawrence Osteoarthritis Grade.
Measured: 2 and 6 weeks, 3, 6, 12 and 24 months
Device and Supplemental Fixation Breakage
Device and Supplemental Fixation Breakage will be assessed via all available x-ray images
Measured: 2 and 6 weeks, 3, 6, 12 and 24 months
Visual Analogue Scale Pain Severity
A Visual Analogue Scale patient questionnaire will be used to define the pain in the specific regions (cervical or lumbar) in the course of the study. 0 will be defined as "no pain" and 10 the Worst Possible Pain.
Measured: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
EQ-5D
The EQ-5D questionnaire is a standard generic patient questionnaire used to determine the health-related quality of life changes in the course of the study.
Measured: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Prolo Scale
The Prolo Scale is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient in the course of this study.
Measured: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start7 Dec 2021
- Primary completion12 Feb 2025
- Study completion21 Mar 2025
Why it stopped: Sponsor terminated the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- K2M, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911257
- Sponsor's protocol ID
- CAS-017
- Status last verified
- Apr 2025
- First submitted
- 17 May 2021
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Prospective Evaluation for Clinical and Radiographic Outcomes Utilizing Stryker Spine Cervical and Lumbar Interbody Systems: Observational Post Market Clinical Follow up Study
- ClinicalTrials.gov ID
- NCT04911257
- Acronym / sponsor ID
- CAS-017
- Conditions
- Degenerative Disc Disease
- Keywords
- Spondylolisthesis, Degenerative Scoliosis, Retrolisthesis.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor terminated the study
- Enrolment
- 28 participants (actual)
- Lead sponsor
- K2M, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 3 Jun 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 is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).
The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 < -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degenerate Disc Disease | – | Device: Cervical or Lumbar Spinal fusionSubjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will include patients that present with on-label conditions that will be surgically treated by participating investigators.
Key inclusion criteria (16 listed)
- Must be planned to undergo spinal fusion surgery utilizing Stryker Interbody Systems for on label indications, which are listed below as inclusion criteria.
- Diagnosed with degenerative disc disease (DDD).
- Outside of USA, Tritanium is indicated for use in patients with diagnosis of Degenerative Spine Disorders, Spine Revision, Discal and Vertebral Instability; and there is no restriction to Spondylolisthesis Grade.
- Willingness and ability to comply with the requirements of the protocol including follow up requirements.
- Willing and able to sign a study specific informed consent form.
Key exclusion criteria (20 listed)
- Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery.
- For the Tritanium and Monterey AL systems: Any neuromuscular deficit which places an unsafe load on the device during the healing period.
- For the Cascadia, Chesapeake, Mojave and Sahara systems: Metabolic disorders of calcified tissues.
- Biological factors such as smoking or using nonsteroidal anti inflammatory agents/ anticoagulants.
- Immunosuppressive disorders.
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 |
|---|---|---|
| Cervical or Lumbar Spinal fusionThis is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems. | Device | Degenerate Disc Disease |
Primary outcome
Mean Oswestry Disability Index Change
Time frame: 12 Months
Oswestry Disability Index (ODI) (lumbar) improvement from baseline to 12 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.
Mean Neck Disability Index Change
Time frame: 12 Months
Neck Disability Index (NDI) (cervical) improvement from baseline to 12 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.
15 secondary outcomes
Mean Oswestry Disability Index Change
Time frame: 24 Months
Mean Neck Disability Index Change
Time frame: 24 months
Safety Events
Time frame: 24 months
Fusion Status
Time frame: 3, 6, 12 and 24 months
Angular Motion
Time frame: 3, 6, 12 and 24 months
Translational Motion
Time frame: 3, 6, 12 and 24 months
Bridging Bone
Time frame: 3, 6, 12 and 24 months
Disc Height
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Device Migration
Time frame: 6 weeks, 3, 6, 12 and 24 months
Subsidence
Time frame: 6 weeks, 3, 6, 12 and 24 months
Adjacent Segment Degeneration
Time frame: 2 and 6 weeks, 3, 6, 12 and 24 months
Device and Supplemental Fixation Breakage
Time frame: 2 and 6 weeks, 3, 6, 12 and 24 months
Visual Analogue Scale Pain Severity
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
EQ-5D
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Prolo Scale
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Results and safety
The study was stopped early (reason given: Sponsor terminated the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by K2M, Inc. at 4 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 16 inclusion and 20 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: stopped early, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was stopped early (reason given: Sponsor terminated the study). Results are not available in the source record.
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?
Mean Oswestry Disability Index Change (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.