PRESTIGE Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT00875810
First received: April 1, 2009
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: December 19, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Degenerative Cervical Disc Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cervical Arthroplasty + Prestige LP All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.

Participant Flow:   Overall Study
    Cervical Arthroplasty + Prestige LP  
STARTED     194  
Implanted     190  
Discharged     177  
3 Months Follow up     175  
6 Months Follow up     80  
12 Months Follow up     112  
24 Months Follow up     148  
COMPLETED     148  
NOT COMPLETED     46  
Withdrawal by Subject                 1  
Physician Decision                 3  
Lost to Follow-up                 39  
Patient enroled but not implanted                 2  
Device explanted                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cervical Arthroplasty + Prestige LP All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.

Baseline Measures
    Cervical Arthroplasty + Prestige LP  
Number of Participants  
[units: participants]
  190  
Age  
[units: years]
Mean (Standard Deviation)
  43.9  (8.6)  
Gender  
[units: participants]
 
Female     127  
Male     63  
Region of Enrollment  
[units: participants]
 
Serbia     10  
Saudi Arabia     11  
Hungary     13  
Czech Republic     44  
Slovakia     28  
Poland     83  
Kuwait     1  



  Outcome Measures
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1.  Primary:   EQ-5D   [ Time Frame: 2 years ]

2.  Primary:   Neck Disability Index (NDI) Score   [ Time Frame: 2 years ]

3.  Secondary:   Duration of Pain Prior to Enrollment   [ Time Frame: Baseline visit ]

4.  Secondary:   Intervertebral Disc Space   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low patient compliance at the 6 and 12 months follow up visits


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Cristina Faria
Organization: MedtronicSpineECA
phone: +41 21 802 70 00
e-mail: cristina.faria@medtronic.com



Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00875810     History of Changes
Other Study ID Numbers: PRESTIGE Observational Study
Study First Received: April 1, 2009
Results First Received: December 19, 2014
Last Updated: January 26, 2016
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