Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

PRESTIGE Observational Study

26 januari 2016 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

194

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Grekland
      • Athens, Grekland
        • 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
  • Saudiarabien
      • Jeddah, Saudiarabien
        • 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
  • Slovakien
      • Nové Zamky, Slovakien
        • NsP Nové Zámky Hospital
  • Tjeckien
      • Plzen, Tjeckien, 32318
        • Hospital Plzen - Lochotin
      • Plzen, Tjeckien
        • Hospital Plzen - Lochotin
      • Prague, Tjeckien
        • University Clinic Motol
  • Ungern
      • Budapest, Ungern
        • National Center for Spinal Disorders
      • Budapest, Ungern, 1126
        • National Center for Spinal Disorders

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
EQ-5D
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Pain Prior to Enrollment
Tidsram: Baseline visit
Documentation of duration of pain prior to enrollment
Baseline visit
Intervertebral Disc Space
Tidsram: 2 years
2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medtronic Spinal and Biologics

Utredare

  • Huvudutredare: Jan Štulik, MUDr, University Clinic Motol

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 november 2013

Avslutad studie (Faktisk)

1 november 2013

Studieregistreringsdatum

Först inskickad

1 april 2009

Först inskickad som uppfyllde QC-kriterierna

2 april 2009

Första postat (Uppskatta)

3 april 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

28 januari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 januari 2016

Senast verifierad

1 januari 2016

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PRESTIGE Observational Study

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Degenerativ cervikal disksjukdom

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Moldova

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera