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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Rush University Medical Center; Department of Orthopedic Surgery
Chicago, Illinois, United States
Safety/Adverse Events
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.
Time frame: Up to 24 months
Disability
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
Time frame: 24 months
Change in Disability
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
Time frame: Up to 24 months
Pain
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
Time frame: 24 months
Change in Pain
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
Time frame: Up to 24 months
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Health-Related Quality of Life Questionnaire
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
Time frame: 24 months
Change in Health-Related Quality of Life Questionnaire
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
Time frame: Up to 24 months
Arthrodesis (Fusion)
CT based fusion assessment at 6 months, 12 months, and 24 months
Time frame: 6 months, 12 months, 24 months
Radiographic Analysis (Global Lumbar Lordosis)
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.
Time frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits
Radiographic Analysis (Segmental Lumbar Lordosis)
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.
Time frame: Immediate Postoperative, 6-week, 12-week, 6-month, 12-month, 24-month follow-up visits