FLXfit Post Market Outcome Study Protocol

NCT02882243 | Completed

• 1 other identifier: 20-CL-027
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Degenerative Disc Disease Lumbar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disc Height

  at 6 months

Interventions

FLXfit Cage for fusion DEVICE

Evaluating patient outcomes and radiographic outcomes

Also known as: Transforaminal Interbody Fusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• CoreLink, LLC: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 29, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07