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

Not Applicable

• Conditions: Degenerative Disc Disease; Spondylolisthesis; Retrolisthesis
• Interventions: Device: FLXfit™ TLIF Interbody Fusion Device

• Registration Number: NCT02805985
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-25
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLXfit™ TLIF Interbody Fusion 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

Name	Time	Method
Safety/Adverse Events	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

Name	Time	Method
Disability	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
Pain	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
Change in Pain	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
Health-Related Quality of Life Questionnaire	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
Arthrodesis (Fusion)	6 months, 12 months, 24 months	CT based fusion assessment at 6 months, 12 months, and 24 months
Radiographic Analysis (Global Lumbar Lordosis)	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.
Radiographic Analysis (Segmental Lumbar Lordosis)	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.
Change in Disability	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
Change in Health-Related Quality of Life Questionnaire	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

Trial Locations

Locations (1)

Rush University Medical Center; Department of Orthopedic Surgery; 🇺🇸 Chicago, Illinois, United States