- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
- 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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Improvement in Oswestry Disability Index (ODI) score
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disc Height
Zeitfenster: at 6 months
|
measurement of overall lumbar lordosis and segmental disc height
|
at 6 months
|
Mitarbeiter und Ermittler
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20-CL-027
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur FLXfit Cage for fusion
-
Expanding Orthopedics Ltd.Rush University Medical CenterUnbekanntDegenerative Bandscheibenerkrankungen | Spondylolisthese | RetrolisthesisVereinigte Staaten