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PRESTIGE Observational Study

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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

Study Type Observational
Study Design Time Perspective: Prospective
Condition Degenerative Cervical Disc Disease
Enrollment 194
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description 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.
Period Title: Overall Study
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
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             3
Lost to Follow-up             39
Patient enroled but not implanted             2
Device explanted             1
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants
43.9  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants
Female
127
  66.8%
Male
63
  33.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 190 participants
Serbia 10
Saudi Arabia 11
Hungary 13
Czech Republic 44
Slovakia 28
Poland 83
Kuwait 1
1.Primary Outcome
Title EQ-5D
Hide Description

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.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.59  (0.22)
3 months Follow up 0.78  (0.16)
6 months Follow up 0.77  (0.20)
12 months Follow up 0.80  (0.19)
24 months Follow up 0.76  (0.21)
2.Primary Outcome
Title Neck Disability Index (NDI) Score
Hide Description

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.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 24.1  (8.6)
3 months Follow up 13.2  (8.9)
6 months Follow up 12.6  (10.2)
12 months Follow up 12.3  (10.0)
24 months 13.4  (10.3)
3.Secondary Outcome
Title Duration of Pain Prior to Enrollment
Hide Description Documentation of duration of pain prior to enrollment
Time Frame Baseline visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 190
Measure Type: Number
Unit of Measure: percentage of patients with pain
patients with pain for 3-6 months before surgery 22.1
patients with pain for 6-12 months before surgery 21.3
patients with pain for >12 months before surgery 37.4
4.Secondary Outcome
Title Intervertebral Disc Space
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow.
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: millimiters
Baseline 0.22  (0.07)
3 months Follow up 0.41  (0.15)
6 months Follow up 0.42  (0.16)
12 months Follow up 0.40  (0.14)
24 months Follow up 0.39  (0.13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervical Arthroplasty + Prestige LP
Hide Arm/Group Description 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.
All-Cause Mortality
Cervical Arthroplasty + Prestige LP
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cervical Arthroplasty + Prestige LP
Affected / at Risk (%) # Events
Total   7/190 (3.68%)    
General disorders   
Wound hematoma  1/190 (0.53%)  1
Musculoskeletal and connective tissue disorders   
Lumbar pain  2/190 (1.05%)  3
Arm pain  1/190 (0.53%)  1
Quervain syndrome  1/190 (0.53%)  1
Nervous system disorders   
syndroma carpi radialis  1/190 (0.53%)  1
Thoracic spine discopathy  1/190 (0.53%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervical Arthroplasty + Prestige LP
Affected / at Risk (%) # Events
Total   40/190 (21.05%)    
General disorders   
Neck, shoulder and arm pain  24/190 (12.63%)  25
Lumbar pain  16/190 (8.42%)  18
Low patient compliance at the 6 and 12 months follow up visits
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 sponsor can review results communications prior to public release. The sponsor will limit its review to the determination of whether Confidential Information is disclosed and to check for technical correctness.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cristina Faria
Organization: MedtronicSpineECA
Phone: +41 21 802 70 00
EMail: cristina.faria@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT00875810     History of Changes
Other Study ID Numbers: PRESTIGE Observational Study
First Submitted: April 1, 2009
First Posted: April 3, 2009
Results First Submitted: December 19, 2014
Results First Posted: March 17, 2015
Last Update Posted: January 28, 2016