Study Results
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View full resultsBasic Information
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COMPLETED
194 participants
OBSERVATIONAL
2008-04-30
2013-11-30
Brief Summary
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The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
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Detailed Description
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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.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Medtronic Spinal and Biologics
INDUSTRY
Responsible Party
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Principal Investigators
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Jan Štulik, MUDr
Role: PRINCIPAL_INVESTIGATOR
University Clinic Motol
Locations
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Hospital Plzen - Lochotin
Pilsen, , Czechia
Hospital Plzen - Lochotin
Pilsen, , Czechia
University Clinic Motol
Prague, , Czechia
Agia Olga Hospital
Athens, , Greece
National Center for Spinal Disorders
Budapest, , Hungary
National Center for Spinal Disorders
Budapest, , Hungary
Al-Salam International Hospital
Kuwait City, , Kuwait
Razi Hospital for Orthopedic Surgery
Kuwait City, , Kuwait
Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
Konstancin-Jeziorna, , Poland
Centrum Ksztalcenia I Rehabilitcji
Konstancin, , Poland
Centrum Ksztalcenia I Rehabilitcji
Konstancin, , Poland
Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
Konstancin, , Poland
State Hospital- Wojewodzkie Centrum
Opole, , Poland
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin, , Poland
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin, , Poland
Orthopaedic University Hospital in Zakopane
Zakopane, , Poland
Orthopaedic University Hospital in Zakopane
Zakopane, , Poland
State Hospital- Szpital Wojewodzki
Zielona Góra, , Poland
King Faisal Specialist Hospital & Research Center
Jeddah, , Saudi Arabia
Neurosurgical Clinic KCS
Belgrade, , Serbia
Neurosurgical Clinic KCS
Belgrade, , Serbia
Clinical Center Nis Neurosurgical Clinic
Niš, , Serbia
Clinical Center Niš
Niš, , Serbia
Clinical Center of Vojvodina Neurosurgical Clinic
Novi Sad, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
NsP Nové Zámky Hospital
Nové Zamky, , Slovakia
Countries
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Other Identifiers
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PRESTIGE Observational Study
Identifier Type: -
Identifier Source: org_study_id
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