FLXfitTM 15 TLIF Interbody Fusion Device

March 13, 2023 updated by: Kern Singh, MD, Rush University Medical Center

Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device

The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (studydevice) system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is post-market, patient outcome research to evaluate medical device safety and effectiveness. The data collected will assess the safety of the FLXfit 15TM (study device) system, as measured by the rate of serious operative and post-operative complications. It will also assess the effectiveness as measured by radiographs (X-rays), CT scans, MRI scans, patient-reported, health-related quality of life questionnaires up to (24) months following the procedure, as compared to before surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Adult (18-70 y/o)
  • 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
    • Spondylolisthesis
  • Failure of at least 6-months 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
  • Ability to read, understand, and sign informed consent

Exclusion Criteria:

  • Infection, local to the operative site
  • Signs of local inflammation
  • Fever or leukocytosis
  • Pregnancy
  • Significant mental disorder or condition that could compromise the patient's ability to remember and comply with preoperative and postoperative instructions (e.g. current treatment for a psychiatric/psychosocial disorder, senile dementia, Alzheimer's disease, traumatic head injury)
  • Prior surgical procedure (with the exception of decompression only procedure) at the index level(s) using the desired operative approach
  • Prior fusion procedure at an adjacent level
  • 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
  • Neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care
  • Active local infection in or near the operative region
  • Active systemic infection and/or disease
  • Severe osteoporosis or insufficient bone density, which in the medical opinion of the physician precludes surgery or contraindicates instrumentation
  • Endocrine or metabolic disorders known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, hypothyroidism)
  • Systemic disease that requires the chronic administration of nonsteroidal anti- inflammatory or steroidal drugs
  • Suspected or documented allergy or intolerance to implant's materials
  • Symptomatic cardiac disease
  • Patient unwilling to cooperate with postoperative instructions.
  • Any case where the implant components selected for use would be too large or too small to achieve a successful result.
  • 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.
  • Back VAS < 4/10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FLXfit 15
The FLXfit 15 device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.
Device: FLXfit 15TM device
In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: through study completion; 2 year
Did patient achieve fusion?
through study completion; 2 year
Visual Analogue Pain Scale: Back
Time Frame: 6-week
0 to 10 score; higher score means worse pain
6-week
Visual Analogue Pain Scale: Back
Time Frame: 12- week
0 to 10 score; higher score means worse pain
12- week
Visual Analogue Pain Scale: Back
Time Frame: 6-month
0 to 10 score; higher score means worse pain
6-month
Visual Analogue Pain Scale: Back
Time Frame: 1-year
0 to 10 score; higher score means worse pain
1-year
Visual Analogue Pain Scale: Back
Time Frame: 2-year
0 to 10 score; higher score means worse pain
2-year
Visual Analogue Pain Scale: Leg
Time Frame: 6-week
0 to 10 score; higher score means worse pain
6-week
Visual Analogue Pain Scale: Leg
Time Frame: 12- week
0 to 10 score; higher score means worse pain
12- week
Visual Analogue Pain Scale: Leg
Time Frame: 6-month
0 to 10 score; higher score means worse pain
6-month
Visual Analogue Pain Scale: Leg
Time Frame: 1-year
0 to 10 score; higher score means worse pain
1-year
Visual Analogue Pain Scale: Leg
Time Frame: 2-year
0 to 10 score; higher score means worse pain
2-year
Oswestry Disability Index
Time Frame: 6-week
0 to 100 score; higher score means greater patient disability
6-week
Oswestry Disability Index
Time Frame: 12- week
0 to 100 score; higher score means greater patient disability
12- week
Oswestry Disability Index
Time Frame: 6-month
0 to 100 score; higher score means greater patient disability
6-month
Oswestry Disability Index
Time Frame: 1-year
0 to 100 score; higher score means greater patient disability
1-year
Oswestry Disability Index
Time Frame: 2-year
0 to 100 score; higher score means greater patient disability
2-year
Short Form-12 Health Survey
Time Frame: 6-week
0 to 100 score; higher score means less patient disability
6-week
Short Form-12 Health Survey
Time Frame: 12-week
0 to 100 score; higher score means less patient disability
12-week
Short Form-12 Health Survey
Time Frame: 6-month
0 to 100 score; higher score means less patient disability
6-month
Short Form-12 Health Survey
Time Frame: 1-year
0 to 100 score; higher score means less patient disability
1-year
Short Form-12 Health Survey
Time Frame: 2-year
0 to 100 score; higher score means less patient disability
2-year
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 6-week
20 to 80 score; higher score means higher reported self-capability
6-week
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 12- week
20 to 80 score; higher score means higher reported self-capability
12- week
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 6-month
20 to 80 score; higher score means higher reported self-capability
6-month
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 1-year
20 to 80 score; higher score means higher reported self-capability
1-year
Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: 2-year
20 to 80 score; higher score means higher reported self-capability
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18073011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.

IPD Sharing Time Frame

The data will become available after the participant has signed the informed consent and will remain available until the study is closed.

IPD Sharing Access Criteria

The study staff will have to complete HIPPA and confidentiality training. In addition, they must by Midwest Orthopedics staff who will access the information on a password protected and encrypted computer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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