Degenerative Disc Disease LumbarTLIFNCT02882243
FLXfit Post Market Outcome Study Protocol
An observational study of Degenerative Disc Disease Lumbar, run by Foundation for Orthopaedic Research and Education.
Trial summary
This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating: Safety as measured by the rate of serious operative and post-operative complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease Lumbar
- What is being tested?
- FLXfit Cage for fusion
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Up to 50 subjects participating in this post market study will be consecutively recruited from the Clinical Investigators standard patient populations. * The Principal Investigator is responsible for assessing the eligibility of their potential subjects.
Who may be able to join
- Adult (age 18 - 70 years) patient (male or female) with the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Degenerative disc disease
- With up to Grade I spondylolisthesis
- Failure of at least 6 month conservative treatment BMI < 40.
- Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one.
Who cannot join
- This device is not intended for cervical spine use. PI may exclude patient from study
- Contraindications include, but are not limited to:
- Infection, local to the operative site
- Signs of local inflammation,
- Fever or leukocytosis,
- Morbid obesity,
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- Pregnancy,
- Mental illness,
- Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count,
- Suspected or documented allergy or intolerance to implant's materials,
- Any case not described in the indications,
- Any patient unwilling to cooperate with postoperative instructions.
- These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
- Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
- Prior fusion at the level to be treated.
About this study
Official title: Post Market Study on the Safety and Efficiency of FLXfit™ TLIF Interbody Fusion Device (Cage)
This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating:
- Safety as measured by the rate of serious operative and post-operative complications.
- Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.
Read the detailed description
Interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment
- Conditions
- Degenerative Disc Disease Lumbar
- Being tested
- FLXfit Cage for fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLXfit Cage for fusionDevice
Also called Transforaminal Interbody Fusion
Evaluating patient outcomes and radiographic outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Oswestry Disability Index (ODI) score
Oswestry Disability Index is a measure of disability due to back and leg pain
Measured: Baseline, 6 week, 3 month, 6 month, 12 month, 24 month follow-up
Secondary outcomes (1)
Disc Height
measurement of overall lumbar lordosis and segmental disc height
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease LumbarStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- CoreLink, LLC
- Responsible party
- Principal investigator, Marc Weinstein, Foundation for Orthopaedic Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882243
- Sponsor's protocol ID
- 20-CL-027
- Acronym
- TLIF
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2016
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: not at this time
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study on the Safety and Efficiency of FLXfit™ TLIF Interbody Fusion Device (Cage)
- ClinicalTrials.gov ID
- NCT02882243
- Acronym / sponsor ID
- TLIF / 20-CL-027
- Conditions
- Degenerative Disc Disease Lumbar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- CoreLink, LLC
- Study start
- Jul 2016
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating:
- Safety as measured by the rate of serious operative and post-operative complications.
- Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.
Detailed description
Interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Up to 50 subjects participating in this post market study will be consecutively recruited from the Clinical Investigators standard patient populations. * The Principal Investigator is responsible for assessing the eligibility of their potential subjects.
Key inclusion criteria (5 listed)
- Adult (age 18 - 70 years) patient (male or female) with the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:
- Failure of at least 6 month conservative treatment BMI < 40.
- Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one.
Key exclusion criteria (17 listed)
- This device is not intended for cervical spine use. PI may exclude patient from study
- Infection, local to the operative site
- Signs of local inflammation,
- Fever or leukocytosis,
- Morbid obesity,
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 |
|---|---|---|
| FLXfit Cage for fusionAlso: Transforaminal Interbody FusionEvaluating patient outcomes and radiographic outcomes | Device | – |
Primary outcome
Improvement in Oswestry Disability Index (ODI) score
Time frame: Baseline, 6 week, 3 month, 6 month, 12 month, 24 month follow-up
Oswestry Disability Index is a measure of disability due to back and leg pain
1 secondary outcome
Disc Height
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided. not at this time
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease Lumbar, run by Foundation for Orthopaedic Research and Education.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Oswestry Disability Index (ODI) score (time frame: Baseline, 6 week, 3 month, 6 month, 12 month, 24 month follow-up). 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 27 Jul 2022.