FLXfitTM 15 TLIF Interbody Fusion Device

Post-market Surveillance Study of FLXfitTM 15 TLIF Interbody Fusion Device

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: FLXfit 15TM device

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
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	Did patient achieve fusion?	through study completion; 2 year
Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	6-week
Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	12- week
Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	6-month
Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	1-year
Visual Analogue Pain Scale: Back	0 to 10 score; higher score means worse pain	2-year
Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	6-week
Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	12- week
Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	6-month
Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	1-year
Visual Analogue Pain Scale: Leg	0 to 10 score; higher score means worse pain	2-year
Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	6-week
Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	12- week
Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	6-month
Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	1-year
Oswestry Disability Index	0 to 100 score; higher score means greater patient disability	2-year
Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	6-week
Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	12-week
Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	6-month
Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	1-year
Short Form-12 Health Survey	0 to 100 score; higher score means less patient disability	2-year
Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	6-week
Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	12- week
Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	6-month
Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	1-year
Patient Reported Outcomes Measurement Information System (PROMIS)	20 to 80 score; higher score means higher reported self-capability	2-year

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): August 22, 2022

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 18073011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All study related documents will be shared through a password protected and encrypted program managed by Midwest Orthopedics IT department.
• IPD Sharing Time Frame: The data will become available after the participant has signed the informed consent and will remain available until the study is closed.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• 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