Degenerative Disc DiseaseNCT03817606
A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant
A study testing Tritanium Posterior Lumbar Cage and AVS UniLIF PEEK Posterior Lumbar Cage in people with Degenerative Disc Disease and Degenerative Scoliosis, run by Riverside Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Degenerative Scoliosis
- What is being tested?
- Tritanium Posterior Lumbar Cage and AVS UniLIF PEEK Posterior Lumbar Cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is skeletally mature
- Subject has one or more of the following diagnoses:
- Degenerative Disc Disease (DDD) at one level or two contiguous levels from L2 to S1
- DDD may include up to Grade 1 spondylolisthesis at the involved level(s)
- Degenerative Scoliosis for which the interbody fusion device will be used as an adjunct to fusion
- Subject has received 6 months of non-operative therapy
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- Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
- Subject agrees to comply with visit schedule and study assessments
- Provision of signed and dated informed consent form
- Subject stated willingness to comply with all study procedures and availability for the duration of the study
- Subject is in good general health as evidenced by medical history
Who cannot join
- Subject is obese (BMI > 40)
- Subject is sensitive to titanium materials
- Subject has an active infection at the operative site
- Subject has marked local inflammation
- Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis
- Subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care
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- Subject has any open wounds
- Subject is pregnant or plans to become pregnant during the course of the study
- Subject has inadequate tissue coverage over the operative site.
- Subject has an neuromuscular deficit which places an unsafe load on the device during the healing period
- Subject has any condition of senility, mental illness, or substance abuse
- Subject has any 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.
- Subject has prior fusion at the levels to be treated
- Subject is incarcerated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
Read the detailed description
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
- Conditions
- Degenerative Disc Disease, Degenerative Scoliosis
- Being tested
- Tritanium Posterior Lumbar Cage, AVS UniLIF PEEK Posterior Lumbar Cage
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tritanium Posterior Lumbar CageDevice
Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
AVS UniLIF PEEK Posterior Lumbar CageDevice
Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
| Study group | Role | What they receive |
|---|---|---|
| Tritanium Posterior Lumbar Cage | Experimental | Surgical placement of the Tritanium Posterior Lumbar Cage Receives: Device: Tritanium Posterior Lumbar Cage |
| AVS PEEK UniLIF | Active comparator | Surgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage Receives: Device: AVS UniLIF PEEK Posterior Lumbar Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Fusion Success
CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
Measured: 12 Months
Secondary outcomes (7)
Change in Visual Analogue Scale
Change in low back pain as indicated by Visual Analogue Scale (VAS). The VAS measures subjects' self-reported pain level on a 100 mm line on which the subject indicates their level of pain, where 0 is no pain and 100 is worst imaginable pain.
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Low Back Function
Change in Oswestry Disability Index (ODI) score. The ODI assesses disability related to lower back pain using a Likert 0 to 5 scale. There are 10 sections to the assessment, and the scores are represented as a percentage ranging from 0 (no disability) to 100 (completely disabled).
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: SF-36 PCS
Change in perception of quality of life, as measured by Short Form 36 Health Survey (SF-36 PCS). The SF-36 PCS is a 36-item patient reported health questionnaire to measure perceived quality of life across 8 domains. Higher scores indicate higher quality of life, and lower scores indicate lower quality of life. Scores range from 5 (poor physical function) to 80 (excellent clinical function).
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
Number of Participants That Return to Work
Subjects who were unable to work due to their back pain who return to work.
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Ambulatory Status
Amount of time to full ambulation without assistance for study participants who had no or partial ambulation at baseline.
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Number of Participants With Serious Adverse Events
Any event meeting the Serious Adverse Event reporting criteria detailed in the study protocol occurring at the following time intervals: TLIF procedure, hospital recovery and discharge, and 6 weeks-, 3 months-, 6 months- and 12 months post operation
Measured: 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: EQ-5d
Change in perception of quality of life, as measured by the EuroQol-5d (EQ-5d). The EuroQol-5d is a five question broad quality of life measure that can be combined into a single index and represents current health. A score of 0.0 is the worst imaginable health while a score of 1.0 would be the best imaginable health.
Measured: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Mar 2019
- Primary completion30 Jun 2020
- Study completion27 Apr 2021
Why it stopped: Due to COVID-19 disruption
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VB Spine, LLC
- Responsible party
- Principal investigator, Juan Jimenez, Riverside Medical Center
- Investigators
- Lisa Zipsie, Study director, Riverside Medical CenterJuan Jimenez, MD, Principal investigator, Riverside Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817606
- Sponsor's protocol ID
- RMC193
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2018
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant on Spinal Fusion in Patients With Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT03817606
- Acronym / sponsor ID
- RMC193
- Conditions
- Degenerative Disc Disease, Degenerative Scoliosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 disruption
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Riverside Medical CenterUniversity, hospital or other
- Collaborators
- VB Spine, LLC
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
Detailed description
This study protocol intends to examine the difference in efficacy between the Tritanium Posterior Lumbar Cage and the UniLIF PEEK implant with respect to how long it takes to achieve fusion of the spine. Study participants will undergo a transforaminal lumbar interbody fusion (TLIF) surgery and return for CT and x-ray follow-up to measure the degree to which fusion has been achieved. Survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tritanium Posterior Lumbar Cage | Experimental | Device: Tritanium Posterior Lumbar CageSurgical placement of the Tritanium Posterior Lumbar Cage |
| AVS PEEK UniLIF | Active comparator | Device: AVS UniLIF PEEK Posterior Lumbar CageSurgical placement of the AVS PEEK UniLIF Posterior Lumbar Cage |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is skeletally mature
- Subject has one or more of the following diagnoses:
- Subject has received 6 months of non-operative therapy
- Subject understands the conditions of enrollment and is willing to sign and date the Informed Consent
- Subject agrees to comply with visit schedule and study assessments
Key exclusion criteria (14 listed)
- Subject is obese (BMI > 40)
- Subject is sensitive to titanium materials
- Subject has an active infection at the operative site
- Subject has marked local inflammation
- Subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis
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 |
|---|---|---|
| Tritanium Posterior Lumbar CagePlacement of Tritanium Posterior Lumbar Cage via TLIF procedure | Device | Tritanium Posterior Lumbar Cage |
| AVS UniLIF PEEK Posterior Lumbar CagePlacement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure. | Device | AVS PEEK UniLIF |
Primary outcome
Number of Participants With Fusion Success
Time frame: 12 Months
CT and X-ray imaging will be obtained at study visits and Fusion Success will be defined by the following criteria: no lucent area around the implant; no presences of herniated disk, central stenosis, lateral recess stenosis, foraminal stenosis, facet anthropathy; no fracture of the device, graft or vertebra; visible bone formation in or about the graft material; less than 3 degrees of inter-segmental position change on flexion and extension views; presence of subsidence: a migration of more than 3mm into the adjacent vertebra; and the proportion of bridging bone visually estimated over the surface area of the joint
7 secondary outcomes
Change in Visual Analogue Scale
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Low Back Function
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: SF-36 PCS
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation.
Number of Participants That Return to Work
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Ambulatory Status
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Number of Participants With Serious Adverse Events
Time frame: 6 weeks; 3 months; 6 months; and 12 months post operation
Change in Quality of Life: EQ-5d
Time frame: Baseline; 6 weeks; 3 months; 6 months; and 12 months post operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Lisa Zipsie study director
Riverside Medical Center
Juan Jimenez, MD principal investigator
Riverside Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tritanium Posterior Lumbar Cage and AVS UniLIF PEEK Posterior Lumbar Cage in people with Degenerative Disc Disease and Degenerative Scoliosis, run by Riverside Medical Center at 1 site 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 11 inclusion and 14 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Fusion Success (time frame: 12 Months). 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 10 Jan 2023.