FLXfit Post Market Outcome Study Protocol

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

NCT02882243•Foundation for Orthopaedic Research and Education

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.

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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,
+7 more criteria

Key Dates

Start Date

July 1, 2016

Primary Completion Date

January 1, 2022

Completion Date

July 1, 2022

Last Updated

July 27, 2022

Enrollment

ACTUAL participants

Conditions

Degenerative Disc Disease Lumbar

Interventions

FLXfit Cage for fusion

DEVICE

CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

NCT07137559

Chronic Back PainDegenerative Disc Disease Lumbar

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COMPLETEDNA

A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine

NCT03928041

Degenerative Disc Disease LumbarSpondylolisthesis, Grade 1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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