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CompletedNCT04208048Updated Mar 14, 2023

FLXfitTM 15 TLIF Interbody Fusion Device

An observational study in Degenerative Disc Disease, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Rush University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Degenerative Disc Disease
03

In context

Intervertebral Disc Degeneration

464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.

This study's enrollment of 31 is below the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.

Browse Intervertebral Disc Degeneration studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceFLXfit 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.

06

What researchers measure

Primary outcomes

  1. Fusion

    Did patient achieve fusion?

    Time frame: through study completion; 2 year

  2. Visual Analogue Pain Scale: Back

    0 to 10 score; higher score means worse pain

    Time frame: 6-week

  3. Visual Analogue Pain Scale: Back

    0 to 10 score; higher score means worse pain

    Time frame: 12- week

  4. Visual Analogue Pain Scale: Back

    0 to 10 score; higher score means worse pain

    Time frame: 6-month

  5. Visual Analogue Pain Scale: Back

    0 to 10 score; higher score means worse pain

    Time frame: 1-year

  6. Visual Analogue Pain Scale: Back

    0 to 10 score; higher score means worse pain

    Time frame: 2-year

  7. Visual Analogue Pain Scale: Leg

    0 to 10 score; higher score means worse pain

    Time frame: 6-week

  8. Visual Analogue Pain Scale: Leg

    0 to 10 score; higher score means worse pain

    Time frame: 12- week

  9. Visual Analogue Pain Scale: Leg

    0 to 10 score; higher score means worse pain

    Time frame: 6-month

  10. Visual Analogue Pain Scale: Leg

    0 to 10 score; higher score means worse pain

    Time frame: 1-year

  11. Visual Analogue Pain Scale: Leg

    0 to 10 score; higher score means worse pain

    Time frame: 2-year

  12. Oswestry Disability Index

    0 to 100 score; higher score means greater patient disability

    Time frame: 6-week

  13. Oswestry Disability Index

    0 to 100 score; higher score means greater patient disability

    Time frame: 12- week

  14. Oswestry Disability Index

    0 to 100 score; higher score means greater patient disability

    Time frame: 6-month

  15. Oswestry Disability Index

    0 to 100 score; higher score means greater patient disability

    Time frame: 1-year

  16. Oswestry Disability Index

    0 to 100 score; higher score means greater patient disability

    Time frame: 2-year

  17. Short Form-12 Health Survey

    0 to 100 score; higher score means less patient disability

    Time frame: 6-week

  18. Short Form-12 Health Survey

    0 to 100 score; higher score means less patient disability

    Time frame: 12-week

  19. Short Form-12 Health Survey

    0 to 100 score; higher score means less patient disability

    Time frame: 6-month

  20. Short Form-12 Health Survey

    0 to 100 score; higher score means less patient disability

    Time frame: 1-year

  21. Short Form-12 Health Survey

    0 to 100 score; higher score means less patient disability

    Time frame: 2-year

  22. Patient Reported Outcomes Measurement Information System (PROMIS)

    20 to 80 score; higher score means higher reported self-capability

    Time frame: 6-week

  23. Patient Reported Outcomes Measurement Information System (PROMIS)

    20 to 80 score; higher score means higher reported self-capability

    Time frame: 12- week

  24. Patient Reported Outcomes Measurement Information System (PROMIS)

    20 to 80 score; higher score means higher reported self-capability

    Time frame: 6-month

  25. Patient Reported Outcomes Measurement Information System (PROMIS)

    20 to 80 score; higher score means higher reported self-capability

    Time frame: 1-year

  26. Patient Reported Outcomes Measurement Information System (PROMIS)

    20 to 80 score; higher score means higher reported self-capability

    Time frame: 2-year

07

Study locations

1 site
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
08

References and documents

Study documents

  • Informed consent form · Sep 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04208048
Lead sponsor
Rush University Medical Center
Responsible party
Kern Singh, MD (Attending Orthopedic Surgeon, Rush University Medical Center) — Principal investigator
First posted
Dec 23, 2019
Start date
Oct 15, 2018
Primary completion
Mar 1, 2022
Completion
Aug 22, 2022
Last update
Mar 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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