- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02171169
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Study Objective:
The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.
Study Design, Endpoints:
Primary Endpoint:
Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.
Secondary Endpoints:
Health Economic: Operative measures, including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge, as applicable.
Health Economic: Comparative hospital data (from time of admission through time of discharge)
Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).
Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment:
Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.
Study Design, Analyses:
The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
California
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Fullerton, California, États-Unis, 92835
- St. Joseph Heritage Healthcare
-
-
Michigan
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Waterford, Michigan, États-Unis, 48328
- Michigan Spine Institute
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Ohio
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Cleveland, Ohio, États-Unis, 44106
- University Hospitals Case Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adult aged 18 years or older
- Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
- Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons
Exclusion Criteria:
- Subject had history of previous back operations at the time of the index procedure
- Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
- Severe scoliosis in the lumbar region
- Subject was or is currently involved in active litigation
- Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
Transsacral lumbar interbody fusion
|
Transforaminal lumbar interbody fusion
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Safety
Délai: 3 months post-operative
|
Incidence of reported adverse events, including those requiring medical intervention.
|
3 months post-operative
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Health Economic
Délai: Up to 3 months post-operative
|
Operative measures including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge. Comparative hospital data |
Up to 3 months post-operative
|
Clinical Effectiveness
Délai: 3 months post-operative
|
A decrease in back pain compared to baseline at 3 months as measured by Visual Analog Scale A decrease in disability compared to baseline at 3 months as measure by the Oswestry Disability Index
|
3 months post-operative
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Peter Whang, MD, Yale School of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PR-07875
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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