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Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device (FLXFit)

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ClinicalTrials.gov Identifier: NCT02805985
Recruitment Status : Unknown
Verified January 2017 by Expanding Orthopedics Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2016
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
Rush University Medical Center
Information provided by (Responsible Party):
Expanding Orthopedics Ltd.

Brief Summary:
This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spondylolisthesis Retrolisthesis Device: FLXfit™ TLIF Interbody Fusion Device Not Applicable

Detailed Description:

As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.

The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FLXfit™ TLIF Interbody Fusion Device
The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
Device: FLXfit™ TLIF Interbody Fusion Device
The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.




Primary Outcome Measures :
  1. Safety/Adverse Events [ Time Frame: Up to 24 months ]
    All adverse events will be assessed by incidence and time to resolution of postoperative device-related complications and serious adverse events/incidence and time to reoperation/incidence and time to revision. All perioperative adverse events will be noted. Information will be obtained from the operative note regarding blood loos, length of surgery, procedural details and complications. Postoperative events including nausea, vomiting, wound complications, thromboembolic events will be assessed.


Secondary Outcome Measures :
  1. Disability [ Time Frame: 24 months ]
    Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline to 24 months postoperatively

  2. Change in Disability [ Time Frame: Up to 24 months ]
    Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline to 24 months postoperatively

  3. Pain [ Time Frame: 24 months ]
    Obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the VAS from baseline to 24 months postoperatively

  4. Change in Pain [ Time Frame: Up to 24 months ]
    Obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the VAS from baseline to 24 months postoperatively

  5. Health-Related Quality of Life Questionnaire [ Time Frame: 24 months ]
    Obtaining improvement in Short Form-12 health survey up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the SF-12 from baseline to 24 months postoperatively

  6. Change in Health-Related Quality of Life Questionnaire [ Time Frame: Up to 24 months ]
    Obtaining improvement in Short Form-12 health survey up to 24 months following the procedure as compared to patient's baseline. Mean change in score of the SF-12 from baseline to 24 months postoperatively

  7. Arthrodesis (Fusion) [ Time Frame: 6 months, 12 months, 24 months ]
    CT based fusion assessment at 6 months, 12 months, and 24 months

  8. Radiographic Analysis (Global Lumbar Lordosis) [ Time Frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits ]
    Immediate Postoperative, and at the 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits assessing global lumbar lordosis (LL) at the level treated with the FLXfit device.

  9. Radiographic Analysis (Segmental Lumbar Lordosis) [ Time Frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits ]
    Immediate Postoperative, and at the 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits assessing segmental lumbar lordosis (LL) at the level treated with the FLXfit device.



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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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): NCT02805985


Contacts
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Contact: Kern Singh, MD 312-432-2373 kern.singh@rushortho.com

Locations
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United States, Illinois
Rush University Medical Center; Department of Orthopedic Surgery Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Kern Singh, MD    312-432-2373    kern.singh@rushortho.com   
Sponsors and Collaborators
Expanding Orthopedics Ltd.
Rush University Medical Center
Investigators
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Study Director: Dustin H Massel, BS Rush University Medical Center
Study Director: Benjamin C Mayo, BA Rush University Medical Center
Study Director: Fady Hijji, BS Rush University Medical Center
Principal Investigator: Kern Singh, MD Rush University Medical Center

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Responsible Party: Expanding Orthopedics Ltd.
ClinicalTrials.gov Identifier: NCT02805985     History of Changes
Other Study ID Numbers: FLXFit
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Expanding Orthopedics Ltd.:
Degenerative Disc Disease
Spondylolisthesis
Retrolisthesis

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