Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery
Department of Neurosurgery, Chi-Mei Medical Center
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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
Opintotyyppi
Ilmoittautuminen (Odotettu)
Vaihe
- Ei sovellettavissa
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale
Aikaikkuna: 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)
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Fusion Rates
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
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