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Completed

NCT Number: NCT04208048

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLXfit 15TM device

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.

Primary outcomes

  1. Fusion

    Time frame: through study completion; 2 year

    Did patient achieve fusion?

  2. Visual Analogue Pain Scale: Back

    Time frame: 6-week

    0 to 10 score; higher score means worse pain

  3. Visual Analogue Pain Scale: Back

    Time frame: 12- week

    0 to 10 score; higher score means worse pain

  4. Visual Analogue Pain Scale: Back

    Time frame: 6-month

    0 to 10 score; higher score means worse pain

  5. Visual Analogue Pain Scale: Back

    Time frame: 1-year

    0 to 10 score; higher score means worse pain

  6. Visual Analogue Pain Scale: Back

    Time frame: 2-year

    0 to 10 score; higher score means worse pain

  7. Visual Analogue Pain Scale: Leg

    Time frame: 6-week

    0 to 10 score; higher score means worse pain

  8. Visual Analogue Pain Scale: Leg

    Time frame: 12- week

    0 to 10 score; higher score means worse pain

  9. Visual Analogue Pain Scale: Leg

    Time frame: 6-month

    0 to 10 score; higher score means worse pain

  10. Visual Analogue Pain Scale: Leg

    Time frame: 1-year

    0 to 10 score; higher score means worse pain

  11. Visual Analogue Pain Scale: Leg

    Time frame: 2-year

    0 to 10 score; higher score means worse pain

  12. Oswestry Disability Index

    Time frame: 6-week

    0 to 100 score; higher score means greater patient disability

  13. Oswestry Disability Index

    Time frame: 12- week

    0 to 100 score; higher score means greater patient disability

  14. Oswestry Disability Index

    Time frame: 6-month

    0 to 100 score; higher score means greater patient disability

  15. Oswestry Disability Index

    Time frame: 1-year

    0 to 100 score; higher score means greater patient disability

  16. Oswestry Disability Index

    Time frame: 2-year

    0 to 100 score; higher score means greater patient disability

  17. Short Form-12 Health Survey

    Time frame: 6-week

    0 to 100 score; higher score means less patient disability

  18. Short Form-12 Health Survey

    Time frame: 12-week

    0 to 100 score; higher score means less patient disability

  19. Short Form-12 Health Survey

    Time frame: 6-month

    0 to 100 score; higher score means less patient disability

  20. Short Form-12 Health Survey

    Time frame: 1-year

    0 to 100 score; higher score means less patient disability

  21. Short Form-12 Health Survey

    Time frame: 2-year

    0 to 100 score; higher score means less patient disability

  22. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 6-week

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

  23. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 12- week

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

  24. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 6-month

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

  25. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 1-year

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

  26. Patient Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 2-year

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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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