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Completed

NCT Number: NCT01110967

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.

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Key information

Conditions

Degenerative Disc Disease, Lumbar Bone Diseases Disc Herniation, Lumbar Hernia Intervertebral Disc Degeneration Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Masaryk Hospital, Ústí nad Labem, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2010
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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