FLXfit Post Market Outcome Study Protocol (TLIF)

Post Market Study on the Safety and Efficiency of FLXfit™ TLIF Interbody Fusion Device (Cage)

This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating:

• Safety as measured by the rate of serious operative and post-operative complications.
• Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease Lumbar
• Intervention / Treatment: Device: FLXfit Cage for fusion

Detailed Description

Interbody fusion in 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

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Up to 50 subjects participating in this post market study will be consecutively recruited from the Clinical Investigators standard patient populations.
• The Principal Investigator is responsible for assessing the eligibility of their potential subjects.

Description

Inclusion Criteria:

• Adult (age 18 - 70 years) patient (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
• Failure of at least 6 month 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.

Exclusion Criteria:

• This device is not intended for cervical spine use. PI may exclude patient from study

Contraindications include, but are not limited to:

• Infection, local to the operative site
• Signs of local inflammation,
• Fever or leukocytosis,
• Morbid obesity,
• Pregnancy,
• Mental illness,
• 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,
• Suspected or documented allergy or intolerance to implant's materials,
• Any case not described in the indications,
• Any patient unwilling to cooperate with postoperative instructions.
• These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
• Any case where the implant components selected for use would be too large or too small to achieve a successful result.
• Any 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Oswestry Disability Index (ODI) score	Oswestry Disability Index is a measure of disability due to back and leg pain	Baseline, 6 week, 3 month, 6 month, 12 month, 24 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disc Height	measurement of overall lumbar lordosis and segmental disc height	at 6 months

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: CoreLink, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: 20-CL-027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not at this time