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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

Tracking Information
First Submitted Date September 6, 2019
First Posted Date December 23, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date October 15, 2018
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2019)
  • Fusion [ Time Frame: through study completion; 2 year ]
    Did patient achieve fusion?
  • Visual Analogue Pain Scale: Back [ Time Frame: 6-week ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Back [ Time Frame: 12- week ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Back [ Time Frame: 6-month ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Back [ Time Frame: 1-year ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Back [ Time Frame: 2-year ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Leg [ Time Frame: 6-week ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Leg [ Time Frame: 12- week ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Leg [ Time Frame: 6-month ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Leg [ Time Frame: 1-year ]
    0 to 10 score; higher score means worse pain
  • Visual Analogue Pain Scale: Leg [ Time Frame: 2-year ]
    0 to 10 score; higher score means worse pain
  • Oswestry Disability Index [ Time Frame: 6-week ]
    0 to 100 score; higher score means greater patient disability
  • Oswestry Disability Index [ Time Frame: 12- week ]
    0 to 100 score; higher score means greater patient disability
  • Oswestry Disability Index [ Time Frame: 6-month ]
    0 to 100 score; higher score means greater patient disability
  • Oswestry Disability Index [ Time Frame: 1-year ]
    0 to 100 score; higher score means greater patient disability
  • Oswestry Disability Index [ Time Frame: 2-year ]
    0 to 100 score; higher score means greater patient disability
  • Short Form-12 Health Survey [ Time Frame: 6-week ]
    0 to 100 score; higher score means less patient disability
  • Short Form-12 Health Survey [ Time Frame: 12-week ]
    0 to 100 score; higher score means less patient disability
  • Short Form-12 Health Survey [ Time Frame: 6-month ]
    0 to 100 score; higher score means less patient disability
  • Short Form-12 Health Survey [ Time Frame: 1-year ]
    0 to 100 score; higher score means less patient disability
  • Short Form-12 Health Survey [ Time Frame: 2-year ]
    0 to 100 score; higher score means less patient disability
  • Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 6-week ]
    20 to 80 score; higher score means higher reported self-capability
  • Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 12- week ]
    20 to 80 score; higher score means higher reported self-capability
  • Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 6-month ]
    20 to 80 score; higher score means higher reported self-capability
  • Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 1-year ]
    20 to 80 score; higher score means higher reported self-capability
  • Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 2-year ]
    20 to 80 score; higher score means higher reported self-capability
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FLXfitTM 15 TLIF Interbody Fusion Device
Official Title Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Degenerative Disc Disease
Intervention 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.
Study Groups/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.
Intervention: Device: FLXfit 15TM device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 18, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04208048
Other Study ID Numbers 18073011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Kern Singh, Rush University Medical Center
Study Sponsor Rush University Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Rush University Medical Center
Verification Date December 2019