- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05190055
Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery
Department of Neurosurgery, Chi-Mei Medical Center
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fusion Rates
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 10508-J01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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M.C. Kruyt, MD, PhDKuros BioSciences B.V.AfsluttetSpinal FusionHolland
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Montefiore Medical CenterAfsluttetSpinal FusionForenede Stater
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Taipei Veterans General Hospital, TaiwanAfsluttet
Kliniske forsøg med bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system
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Benvenue Medical, Inc.UkendtSmerter i lænden | Degenerativ diskussygdom (DDD)Tyskland, Belgien