- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05190055
Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery
Department of Neurosurgery, Chi-Mei Medical Center
Aperçu de l'étude
Statut
Les conditions
Description détaillée
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel. In the case of device group, a novel filler tube with integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling (Figure 1). A polyethyletherketone (PEEK) interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws. The treatment efficacy was assessed by clinical analysis based on the visual analogue scale (VAS) for radicular pain and the Oswestry Disability Index (ODI) questionnaire for low back pain. The VAS back and leg pain scores were measured preoperatively and postoperatively at 1, 3, 6, 12, and 24 months. The ODI questionnaires were taken preoperatively and postoperatively at 3, 6, 12, and 24 months. The bone graft delivery volume and the filling time during the surgery were measured to compare the efficiency of the two approaches.
The X-ray and computed tomography were performed prior to surgery and at 3-, 6-, 12-, and 24-monthspost-surgery for bone fusion assessment. The degree of bone fusion was classified into three grades. Grade I was defined as a complete fusion, union case, and grade II and III was defined as a partial union and a non-union case, respectively. Bone fusion volume was further determined by three-dimensional reconstruction images using ITK-SNAP software
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Exclusion Criteria:
- Patients unsuitable for anesthesia
- Active systemic infection, infection or suspected latent infection localized to the site of the proposed implantation
- Excessive local inflammation
- Rapid joint disease, bone absorption, osteopenia
- Severe osteoporosis or osteopenia
- Morbid obesity
- Pregnancy
- Open wounds
- Patients have demonstrated allergy or foreign body sensitivity to any of the implant materials
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count
- Patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
- Any condition not described in the indications for use
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Minimally invasive spinal fusion surgery
A filler tube with an integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling.
|
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position.
Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints.
The facet joints were removed, and decompression was performed.
The diseased disc nucleus was then excised before filling in the bone substitutes.
In the case of the device group, a novel filler tube with an integrated threaded rod, which can be connected to a surgical drill, A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws.
|
Comparateur actif: traditional spinal fusion surgery
Bone substitutes were filled in the disc space manually using a bone grafting funnel.
|
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position.
Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints.
The facet joints were removed, and decompression was performed.
The diseased disc nucleus was then excised before filling in the bone substitutes.
For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel.
A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale
Délai: Preoperation and 24month post operation
|
The back pain intensity on 100-mm VAS will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
|
Preoperation and 24month post operation
|
Change of function at 24 months from baseline as measured by the 100 points Oswestry Disability Index (ODI)
Délai: Preoperation and 24month post operation
|
The level of function on 100-point ODI will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
|
Preoperation and 24month post operation
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Fusion Rates
Délai: 3, 6, 12, and 24 months
|
Fusion rates for each product as evidenced by bridging bone via x-ray radiograph
|
3, 6, 12, and 24 months
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 10508-J01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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