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PRESTIGE Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00875810
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : March 17, 2015
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Tracking Information
First Submitted Date April 1, 2009
First Posted Date April 3, 2009
Results First Submitted Date December 19, 2014
Results First Posted Date March 17, 2015
Last Update Posted Date January 28, 2016
Study Start Date April 2008
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2015)
  • EQ-5D [ Time Frame: 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.
  • Neck Disability Index (NDI) Score [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: April 2, 2009)
EQ-5D, NDI, VAS [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT00875810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 3, 2015)
  • Duration of Pain Prior to Enrollment [ Time Frame: Baseline visit ]
    Documentation of duration of pain prior to enrollment
  • Intervertebral Disc Space [ Time Frame: 2 years ]
Original Secondary Outcome Measures
 (submitted: April 2, 2009)
  • Duration of Pain Prior to Enrollment [ Time Frame: at Baseline visit ]
  • Drug regimen [ Time Frame: throughout the course of the study ]
  • Range of Motion [ Time Frame: 2 years ]
  • Heterotopic Ossification [ Time Frame: 2 years ]
  • Implantation measurements [ Time Frame: at surgery visit ]
  • Adverse Events [ Time Frame: ongoing throughout the course of the study ]
  • Economic considerations (e.g. days in hospital, return-to-work) [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PRESTIGE Observational Study
Official Title PRESTIGE Observational Study
Brief Summary

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).

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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.
Condition Degenerative Cervical Disc Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 12, 2013)
194
Original Estimated Enrollment
 (submitted: April 2, 2009)
250
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czech Republic,   Greece,   Hungary,   Kuwait,   Poland,   Saudi Arabia,   Serbia,   Slovakia
Removed Location Countries Estonia
 
Administrative Information
NCT Number NCT00875810
Other Study ID Numbers PRESTIGE Observational Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medtronic Spinal and Biologics
Study Sponsor Medtronic Spinal and Biologics
Collaborators Not Provided
Investigators
Principal Investigator: Jan Štulik, MUDr University Clinic Motol
PRS Account Medtronic Spinal and Biologics
Verification Date January 2016