- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02882243
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Oswestry Disability Index (ODI) score
Time Frame: Baseline, 6 week, 3 month, 6 month, 12 month, 24 month follow-up
|
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
Time Frame: at 6 months
|
measurement of overall lumbar lordosis and segmental disc height
|
at 6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-CL-027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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