Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

PRESTIGE Observational Study

26. januar 2016 opdateret af: Medtronic Spinal and Biologics

Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.

The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.

Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.

The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.

Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.

Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.

The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

194

Kontakter og lokationer

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

Studiesteder

  • Grækenland
      • Athens, Grækenland
        • Agia Olga Hospital
  • Kuwait
      • Kuwait, Kuwait
        • Al-Salam International Hospital
      • Kuwait City, Kuwait
        • Al-Salam International Hospital
      • Kuwait City, Kuwait
        • Razi Hospital for Orthopedic Surgery
  • Polen
      • Konstancin, Polen, 05-510
        • Centrum Ksztalcenia I Rehabilitcji
      • Konstancin, Polen
        • Centrum Ksztalcenia I Rehabilitcji
      • Konstancin, Polen
        • Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
      • Konstancin-Jeziorna, Polen, 05-510
        • Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
      • Opole, Polen, 45-418
        • State Hospital- Wojewodzkie Centrum
      • Szczecin, Polen, 70-891
        • Specialist Hospital Prof. Alfreda Sokolowskiego
      • Szczecin, Polen
        • Specialist Hospital Prof. Alfreda Sokolowskiego
      • Zakopane, Polen, 34-500
        • Orthopaedic University Hospital in Zakopane
      • Zakopane, Polen
        • Orthopaedic University Hospital in Zakopane
      • Zielona Gora, Polen, 65-046
        • State Hospital- Szpital Wojewodzki
  • Saudi Arabien
      • Jeddah, Saudi Arabien
        • King Faisal Specialist Hospital & Research Center
  • Serbien
      • Belgrade, Serbien, 11000
        • Neurosurgical Clinic KCS
      • Belgrade, Serbien
        • Neurosurgical Clinic KCS
      • Nis, Serbien, 18000
        • Clinical Center Nis Neurosurgical Clinic
      • Niš, Serbien
        • Clinical Center Nis
      • Novi Sad, Serbien
        • Clinical Center of Vojvodina
      • Novi Sad, Serbien, 21000
        • Clinical Center of Vojvodina Neurosurgical Clinic
  • Slovakiet
      • Nové Zamky, Slovakiet
        • NsP Nové Zámky Hospital
  • Tjekkiet
      • Plzen, Tjekkiet, 32318
        • Hospital Plzen - Lochotin
      • Plzen, Tjekkiet
        • Hospital Plzen - Lochotin
      • Prague, Tjekkiet
        • University Clinic Motol
  • Ungarn
      • Budapest, Ungarn
        • National Center for Spinal Disorders
      • Budapest, Ungarn, 1126
        • National Center for Spinal Disorders

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

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.

Beskrivelse

Inclusion Criteria:

  • Patient must be willing to sign a Patient Data Release Form.
  • Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.

Exclusion Criteria:

  • Patient fulfills any contraindication according to the product description.
  • Patient has not reached the age of legal consent according to local laws.
  • Patient has diabetes.
  • Patient has Body Mass Index (BMI) > 35.
  • Patient has affected disc not between C3/C4 and C6/C7.
  • Patient with instability of cervical spine.
  • Patients who will receive extensive decompression.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EQ-5D
Tidsramme: 2 years

The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).

EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.
2 years
Neck Disability Index (NDI) Score
Tidsramme: 2 years

The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).

The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.

NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Pain Prior to Enrollment
Tidsramme: Baseline visit
Documentation of duration of pain prior to enrollment
Baseline visit
Intervertebral Disc Space
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Spinal and Biologics

Efterforskere

  • Ledende efterforsker: Jan Štulik, MUDr, University Clinic Motol

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. april 2008

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

1. april 2009

Først indsendt, der opfyldte QC-kriterier

2. april 2009

Først opslået (Skøn)

3. april 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PRESTIGE Observational Study

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 .

Kliniske forsøg med Degenerativ cervikal diskussygdom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Netherlands

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner