- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
- 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.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement in Oswestry Disability Index (ODI) score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Disc Height
Tidsramme: at 6 months
|
measurement of overall lumbar lordosis and segmental disc height
|
at 6 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-CL-027
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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