- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
- 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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement in Oswestry Disability Index (ODI) score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Disc Height
Tidsram: at 6 months
|
measurement of overall lumbar lordosis and segmental disc height
|
at 6 months
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20-CL-027
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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