Clinical trial NCT02805985: Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
Official title: Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis
Retrolisthesis
Keywords: Degenerative Disc Disease
Spondylolisthesis
Retrolisthesis
Lead sponsor: Expanding Orthopedics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Rush University Medical Center
First posted: 2016-06-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Safety/Adverse Events
timeFrame: Up to 24 months
Secondary outcomes:
measure: Disability
timeFrame: 24 months
measure: Change in Disability
timeFrame: Up to 24 months
measure: Pain
timeFrame: 24 months
measure: Change in Pain
timeFrame: Up to 24 months
measure: Health-Related Quality of Life Questionnaire
timeFrame: 24 months
measure: Change in Health-Related Quality of Life Questionnaire
timeFrame: Up to 24 months
measure: Arthrodesis (Fusion)
timeFrame: 6 months, 12 months, 24 months
measure: Radiographic Analysis (Global Lumbar Lordosis)
timeFrame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
measure: Radiographic Analysis (Segmental Lumbar Lordosis)
timeFrame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center; Department of Orthopedic Surgery
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Dustin H Massel, BS
role: STUDY_DIRECTOR
affiliation: Rush University Medical Center
name: Benjamin C Mayo, BA
role: STUDY_DIRECTOR
affiliation: Rush University Medical Center
name: Fady Hijji, BS
role: STUDY_DIRECTOR
affiliation: Rush University Medical Center
name: Kern Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: