Satellite™ PEEK Nucleus Replacement Retrospective Analysis

NCT01110967 | Completed Results

• 1 other identifier: Satellite Retrospective
• Study Type: observational
• Target: 40
• Locations: 3 countries
• Sites: 3

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.

Conditions

Degenerative Disc Disease, Lumbar; Disc Herniation, Lumbar

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Range of Motion (ROM) at Implanted Level

  Up to 12 months follow up visit

• Intervertebral Disc Space (IVD) at Implanted Level

  Up to 12 months follow up visit

• Device Subsidence Measured as Interbody Height Ratio (IBHR)

  Up to 12 months follow up visit

• Changes in Device Placement

  Up to 12 months follow up visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient must have signed a Patient Data Release Form
• Age of at least 18 years and skeletally mature at the time of surgery
• Patient has not reached the age of legal consent according to local laws

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (3)

Masaryk Hospital

Ústí nad Labem, Czechia

Location

ÚVN SNP

Ružomberok, Slovakia

Location

Instituto de Columna de Caracas

Caracas, Venezuela

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Cristina Faria
• Organization: Medtronic Spinal & Biologics

cristina.faria@medtronic.com

+41 (0)21 802 70 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 27, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 28, 2016
• Results First Posted: August 7, 2014

Record last verified: 2016-01

Locations

VE (1); SL (1); CZ (1)