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Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy

18. april 2016 opdateret af: Yuntao Lu, Southern Medical University, China

Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection

The lesion located inside the spinal canal caused big trouble for clinical treatment. Traditional laminectomy will destroy the biomechanics and influent the vertebral stability, which might cause kyphosis or other deformity. So in some centers, neurosurgeries praised laminoplasty to make the intactness of posterior column. They thought the laminoplasty can maintain the vertebral stability, and meanwhile the range of motion won't change so much. However, some other scholars thought laminoplasty had no helps for stability because of the pseudarthrosis. They preferred screw and stick system for internal fixation. And we did meet several patients after laminectomy suffered with spinal deformity. So we thought it is necessary for investigating the benefit of patients from laminoplasty and internal fixation.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

After laminectomy for removal of the cervical, thoracic and lumbar lesions, the recruited cases were randomly divided into two groups.

  1. The cases in group of laminoplasty, the lamina and spinous process was replanted to maintain the anatomical intactness of spinal canal.
  2. On the other hand, the cases in internal fixation group, the pedicle screws were implanted, and tickets were used to complete the internal fixation.

During 3 years follow up, the vertebral deformity and the range of motion were investigated and evaluated. And in the meantime, the patient's age will also be analyzed to detect it's influence for the prognosis.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Yuntao Lu, M.D., Ph.D
  • Telefonnummer: +8613632101002
  • E-mail: lllu2000@163.com

Undersøgelse Kontakt Backup

  • Navn: Yiping Mo, Bachelor
  • Telefonnummer: +8620-61641806

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Nan fang hospital, Southern medical university
        • Kontakt:
          • Chongyuan Xu, Ph.D
          • Telefonnummer: +8620-62787238
        • Ledende efterforsker:
          • Yuntao Lu, M.D., Ph.D
        • Underforsker:
          • Lin Pen, M.D.
        • Underforsker:
          • Hai Wang, M.D., Ph.D
        • Underforsker:
          • Jin Shi, Master

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

  1. Adult patients (>18 years) were enrolled.
  2. The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
  3. The cases with pathological malignant tumors were excluded from this study.
  4. Health condition of patients (KPS) > 70.

Beskrivelse

Inclusion Criteria:

- 1. Adult patients (>=18 years) were enrolled. 2. The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.

3. Pathology proved benign lesion. 4. Health condition of patients (KPS) >= 70.

Exclusion Criteria:

  • 1. Children cases (<18 years) were excluded.
  • 2.The cases with pathological malignant tumors were excluded from this study.
  • 3. KPS of patients < 70.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Surgical perfomance (Laminoplasty)
After the lesions inside the spinal canal were surgical removed by laminectomy, the lamina and spinous process were replanted with titanium plates and screws.
Procedure: Surgical performance
Two different surgical performances
Surgical perfomance (Internal fixation)
After the lesions inside the spinal canal were surgical removed by laminectomy, the pedicle screws (Thoracic and lumbar vertebra) or lateral mass (Cervical vertebra) and sticks were used for internal fixation.
Procedure: Surgical performance
Two different surgical performances

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Vertebral deformity
Tidsramme: 3 years
3 years

Sekundære resultatmål

Resultatmål
Tidsramme
The influence of age on the vertebral deformity
Tidsramme: 3 years
3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Southern Medical University, China

Efterforskere

  • Ledende efterforsker: Yuntao Lu, M.D., Ph.D, Nanfang neurosurgery research institution

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Forventet)

1. december 2018

Studieafslutning (Forventet)

1. juli 2019

Datoer for studieregistrering

Først indsendt

4. maj 2015

Først indsendt, der opfyldte QC-kriterier

6. maj 2015

Først opslået (Skøn)

7. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • SMU-spine-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Japan

Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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