Satellite™ PEEK Nucleus Replacement Retrospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease, Lumbar; Disc Herniation, Lumbar

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czech Republic
  • Usti nad Labem, Czech Republic
    • Masaryk Hospital
• Slovakia
  • Ružomberok, Slovakia
    • ÚVN SNP
• Venezuela
  • Caracas, Venezuela
    • Instituto de Columna de Caracas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life Using the Visual Analogue Scale for Back Pain	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.	Up to 12 months follow up visit
Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain	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.	Up to 12 months follow up visit
Physical Functioning Using the Oswestry Disability Index (ODI)	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'.	Up to 12 months follow up visit
Safety by Evaluating the Number of Serious Adverse Device Effects (SADEs), Adverse Device Effects (ADEs) and Serious Adverse Events (SAEs)		Patients were followed up according to the local practice, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion (ROM) at Implanted Level	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).	Up to 12 months follow up visit
Intervertebral Disc Space (IVD) at Implanted Level	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.	Up to 12 months follow up visit
Device Subsidence Measured as Interbody Height Ratio (IBHR)	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.	Up to 12 months follow up visit
Changes in Device Placement		Up to 12 months follow up visit

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration
• Other Study ID Numbers: Satellite Retrospective