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Satellite™ PEEK Nucleus Replacement Retrospective Analysis

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ClinicalTrials.gov Identifier: NCT01110967
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : August 7, 2014
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Degenerative Disc Disease, Lumbar
Disc Herniation, Lumbar
Enrollment 40

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 40
Surgery 40
1 Month Follow up 26
3 Months Follow up 28
6 Months Follow up 24
12 Months Follow up 31
Completed 31
Not Completed 9
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
41  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
15
  37.5%
Male
25
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Czech Republic 2
Slovakia 8
Venezuela 30
1.Primary Outcome
Title Health-related Quality of Life Using the Visual Analogue Scale for Back Pain
Hide Description The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Back pain pre-operative (n = 32) 5.5  (2.7)
Back pain at 1 month Follow up (n = 25) 2.6  (2.2)
Back pain at 3 months Follow up (n = 25) 2.2  (2.3)
Back pain at 6 months Follow up (n = 18) 1.9  (1.8)
Back pain at 12 months Follow up (n = 26) 1.3  (1.6)
2.Primary Outcome
Title Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain
Hide Description The Visual Analogue Scale (VAS) is a tool widely used to measure pain. It is a 10 cm scale, 0cm means 'no pain' and 10cm means 'worst possible pain'. The patients mark the location corresponding to the amount of back pain they experienced on the 10cm line.
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Leg pain pre-operative (n = 30) 7.2  (2.0)
Leg pain at 1 month Follow up (n = 25) 1.8  (2.1)
Leg pain at 3 months Follow up (n = 25) 1.0  (1.3)
Leg pain at 6 months Follow up (n = 18) 0.3  (0.8)
Leg pain at 12 months Follow up (n = 26) 0.3  (0.8)
3.Primary Outcome
Title Physical Functioning Using the Oswestry Disability Index (ODI)
Hide Description The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 50; 0 meaning 'no disability' and 50 meaning 'maximum disability'.
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
ODI pre-operative (n = 38) 48.2  (19.6)
ODI at 1 month Follow up (n = 26) 23.2  (16.0)
ODI at 3 months Follow up (n = 30) 18.6  (12.4)
ODI at 6 months Follow up (n = 23) 17.5  (13.0)
ODI at 12 months Follow up (n = 29) 11.4  (9.2)
4.Primary Outcome
Title Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Patients were followed up according to the local practice, up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: events
7
5.Secondary Outcome
Title Range of Motion (ROM) at Implanted Level
Hide Description The range of motion (ROM) was calculated as the angle of the segment on the flexion radiograph minus the angle of the segment on the extension radiograph, expressed in degrees (absolute value).
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: degrees
ROM pre-operative (n = 22) 10.0  (7.9)
ROM at 3 month Follow up (n = 20) 14.3  (5.8)
ROM at 6 month Follow up (n = 16) 12.1  (9.8)
ROM at 12 month Follow up (n = 16) 14.9  (6.1)
6.Secondary Outcome
Title Intervertebral Disc Space (IVD) at Implanted Level
Hide Description The Intervertebral Disc Space (IVD) was measured as average disc height, calculated as [(A+B)/2]/H, where A is the posterior intervertebral disc height, B is the anterior intervertebral disc height and H is the anterior height of upper vertebral body.
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: mm
IVD pre-operative (n = 35) 0.30  (0.08)
IVD post-operative (n = 29) 0.29  (0.07)
IVD at 3 months Follow up (n = 21) 0.28  (0.07)
IVD at 6 months Follow up (n = 18) 0.26  (0.06)
IVD at 12 months Follow up (n = 19) 0.26  (0.06)
7.Secondary Outcome
Title Device Subsidence Measured as Interbody Height Ratio (IBHR)
Hide Description Interbody Height Ratio (IBHR) is calculated as the total vertical height of the two vertebral bodies directly superior and inferior to the implant divided by the anteroposterior diameter of the superior vertebral body.
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 34
Mean (Standard Deviation)
Unit of Measure: ratio
IBHR at surgery (n = 34) 1.9  (0.2)
IBHR at 3 months Follow up (n = 20) 1.9  (0.2)
IBHR at 6 months Follow up (n = 18) 1.7  (0.2)
IBHR at 12 months Follow up (n = 21) 2.0  (0.7)
8.Secondary Outcome
Title Changes in Device Placement
Hide Description [Not Specified]
Time Frame Up to 12 months follow up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participant
1
Time Frame Patients were followed up according to the local practice, up to 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Implanted With a Satellite Device
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Patients Implanted With a Satellite Device
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Implanted With a Satellite Device
Affected / at Risk (%) # Events
Total   1/40 (2.50%)    
Musculoskeletal and connective tissue disorders   
Residual Radiculopathy  1/40 (2.50%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients Implanted With a Satellite Device
Affected / at Risk (%) # Events
Total   6/40 (15.00%)    
Musculoskeletal and connective tissue disorders   
Residual Radiculopathy  1/40 (2.50%)  1
Back pain and Sciatica  3/40 (7.50%)  3
Low back pain  2/40 (5.00%)  2
Due to the retrospective design, it was not possible to report on SF-36 results and Modic endplate changes results as limited data was available in the patient records.
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.
Confidential Information shall not be disclosed and shall be sole property of sponsor during the term of the agreement and for 3 years after agreement termination. Results might be published or presented, however sponsor should receive publication for review at least 7 days prior to submittal. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed, to allow sponsor to protect its rights in copyrightable material, and to check for technical correctness.
Results Point of Contact
Name/Title: Cristina Faria
Organization: Medtronic Spinal & Biologics
Phone: +41 (0)21 802 70 00
Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01110967     History of Changes
Other Study ID Numbers: Satellite Retrospective
First Submitted: April 15, 2010
First Posted: April 27, 2010
Results First Submitted: May 13, 2014
Results First Posted: August 7, 2014
Last Update Posted: January 28, 2016