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FLXfitTM 15 TLIF Interbody Fusion Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208048
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kern Singh, Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Device: FLXfit 15TM device

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208048


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Kern Singh, Rush University Medical Center:
Informed Consent Form  [PDF] October 15, 2018

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Responsible Party: Kern Singh, Attending Orthopedic Surgeon, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04208048    
Other Study ID Numbers: 18073011
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will become available after the participant has signed the informed consent and will remain available until the study is closed.
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.

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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
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases