Satellite™ PEEK Nucleus Replacement Retrospective Analysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier:
NCT01110967
First received: April 15, 2010
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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
Degenerative Disc Disease, Lumbar
Disc Herniation, Lumbar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Satellite™ PEEK Nucleus Replacement Retrospective Analysis

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal & Biologics ECA:

Primary Outcome Measures:
  • Health-related Quality of Life Using the Visual Analogue Scale for Back Pain [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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.

  • Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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.

  • Physical Functioning Using the Oswestry Disability Index (ODI) [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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'.

  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Range of Motion (ROM) at Implanted Level [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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).

  • Intervertebral Disc Space (IVD) at Implanted Level [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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.

  • Device Subsidence Measured as Interbody Height Ratio (IBHR) [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]
    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.

  • Changes in Device Placement [ Time Frame: Up to 12 months follow up visit ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 & Biologics ECA
  More Information

No publications provided

Responsible Party: Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier: NCT01110967     History of Changes
Other Study ID Numbers: Satellite Retrospective
Study First Received: April 15, 2010
Results First Received: May 13, 2014
Last Updated: July 14, 2014
Health Authority: Venezuela: Ministry of Health and Social Development
Czech Republic: Ethics Committee
Slovak Republic: Ethics Committee

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Degeneration
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 21, 2014