PRESTIGE Observational Study

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).

Study Overview

• Status: Completed
• Conditions: Degenerative Cervical Disc Disease

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.

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.

• Study Type: Observational
• Enrollment (Actual): 194

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Pain Prior to Enrollment	Documentation of duration of pain prior to enrollment	Baseline visit
Intervertebral Disc Space		2 years

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics
• Investigators: Principal Investigator: Jan Štulik, MUDr, University Clinic Motol

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 1, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PRESTIGE Observational Study