PRESTIGE Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier:
NCT00875810
First received: April 1, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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).


Condition
Degenerative Cervical Disc Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PRESTIGE Observational Study

Further study details as provided by Medtronic Spinal & Biologics ECA:

Primary Outcome Measures:
  • EQ-5D, NDI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Duration of pain prior to enrollment [ Time Frame: at Baseline visit ] [ Designated as safety issue: No ]
    Documentation of duration of pain prior to enrollment


Enrollment: 194
Study Start Date: April 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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.

Tthe results of the study demonstrate that PRESTIGE® artificial disc surgery is statistically superior for the following clinically and economically important outcomes measures: Overall success, neurological status, revisions, supplemental fixations and earlier return to work.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with DDD who are scheduled to receive a cervical arthroplasty.

Criteria

Inclusion Criteria:

  • Patient must be willing to sign a Patient Data Release Form.
  • Patient with 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875810

Locations
Czech Republic
Hospital Plzen - Lochotin
Plzen, Czech Republic
Hospital Plzen - Lochotin
Plzen, Czech Republic, 32318
University Clinic Motol
Prague, Czech Republic
Greece
Agia Olga Hospital
Athens, Greece
Hungary
National Center for Spinal Disorders
Budapest, Hungary
National Center for Spinal Disorders
Budapest, Hungary, 1126
Kuwait
Al-Salam International Hospital
Kuwait, Kuwait
Razi Hospital for Orthopedic Surgery
Kuwait City, Kuwait
Al-Salam International Hospital
Kuwait City, Kuwait
Poland
Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
Konstancin, Poland
Centrum Ksztalcenia I Rehabilitcji
Konstancin, Poland, 05-510
Centrum Ksztalcenia I Rehabilitcji
Konstancin, Poland
Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
Konstancin-Jeziorna, Poland, 05-510
State Hospital- Wojewodzkie Centrum
Opole, Poland, 45-418
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin, Poland
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin, Poland, 70-891
Orthopaedic University Hospital in Zakopane
Zakopane, Poland
Orthopaedic University Hospital in Zakopane
Zakopane, Poland, 34-500
State Hospital- Szpital Wojewodzki
Zielona Gora, Poland, 65-046
Saudi Arabia
King Faisal Specialist Hospital & Research Center
Jeddah, Saudi Arabia
Serbia
Neurosurgical Clinic KCS
Belgrade, Serbia, 11000
Neurosurgical Clinic KCS
Belgrade, Serbia
Clinical Center Nis Neurosurgical Clinic
Nis, Serbia, 18000
Clinical Center Niš
Niš, Serbia
Clinical Center of Vojvodina
Novi Sad, Serbia
Clinical Center of Vojvodina Neurosurgical Clinic
Novi Sad, Serbia, 21000
Slovakia
NsP Nové Zámky Hospital
Nové Zamky, Slovakia
Sponsors and Collaborators
Medtronic Spinal & Biologics ECA
Investigators
Principal Investigator: Jan Štulik, MUDr University Clinic Motol
  More Information

No publications provided

Responsible Party: Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier: NCT00875810     History of Changes
Other Study ID Numbers: PRESTIGE Observational Study
Study First Received: April 1, 2009
Last Updated: April 1, 2014
Health Authority: Czech Republic: Ethics Committee
Hungary: Institutional Ethics Committee
Kuwait:Local Ethics Committee
Poland: Ethics Committee
Saudi Arabia: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovak Republic: Ethics Committee

ClinicalTrials.gov processed this record on October 20, 2014