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Satellite™ PEEK Nucleus Replacement Retrospective Analysis

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: 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):

Study Description
Brief Summary:

The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.

The purpose of this study is to evaluate number of adverse device effects (ADEs), serious adverse device effects (SADEs) and serious adverse event (SAEs) and early clinical effectiveness for the Satellite™ Nucleus Replacement in a standard clinical practice. Data collection will include information on health related quality of life (QoL), physical functioning and adverse event after nucleus replacement surgery. Radiographic measures will also be assessed to evaluate changes in disc height at the operated level and changes in segmental range of motion.

All patients who were implanted with a Satellite™ Nucleus Replacement Prosthesis in the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.


Condition or disease
Degenerative Disc Disease, Lumbar Disc Herniation, Lumbar

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Satellite™ PEEK Nucleus Replacement Retrospective Analysis
Study Start Date : April 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Health-related Quality of Life Using the Visual Analogue Scale for Back Pain [ Time Frame: Up to 12 months follow up visit ]
    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.

  2. Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain [ Time Frame: Up to 12 months follow up visit ]
    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.

  3. Physical Functioning Using the Oswestry Disability Index (ODI) [ Time Frame: Up to 12 months follow up visit ]
    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'.

  4. Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs) [ Time Frame: Patients were followed up according to the local practice, up to 1 year ]

Secondary Outcome Measures :
  1. Range of Motion (ROM) at Implanted Level [ Time Frame: Up to 12 months follow up visit ]
    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).

  2. Intervertebral Disc Space (IVD) at Implanted Level [ Time Frame: Up to 12 months follow up visit ]
    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.

  3. Device Subsidence Measured as Interbody Height Ratio (IBHR) [ Time Frame: Up to 12 months follow up visit ]
    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.

  4. Changes in Device Placement [ Time Frame: Up to 12 months follow up visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who were implanted with a Satellite™ Nucleus Replacement device at the participating sites are eligible for participation in the Satellite ™ Retrospective Analysis.
Criteria

Inclusion Criteria:

  • Patient must have signed a Patient Data Release Form
  • Age of at least 18 years and skeletally mature at the time of surgery

Exclusion Criterion:

  • Patient has not reached the age of legal consent according to local laws
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110967


Locations
Czech Republic
Masaryk Hospital
Usti nad Labem, Czech Republic
Slovakia
ÚVN SNP
Ružomberok, Slovakia
Venezuela
Instituto de Columna de Caracas
Caracas, Venezuela
Sponsors and Collaborators
Medtronic Spinal and Biologics
More Information

Responsible Party: Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier: NCT01110967     History of Changes
Other Study ID Numbers: Satellite Retrospective
First Posted: April 27, 2010    Key Record Dates
Results First Posted: August 7, 2014
Last Update Posted: January 28, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases