Degenerative Disc Disease, LumbarNCT01110967

Satellite™ PEEK Nucleus Replacement Retrospective Analysis

An observational study of Degenerative Disc Disease, Lumbar and Disc Herniation, Lumbar, run by Medtronic Spinal and Biologics at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
How many people: 40 participants
Where: 3 sitesin 3 countries
Study dates: Apr 2010to Oct 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

Patient has not reached the age of legal consent according to local laws

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

Czechia1 site

Masaryk Hospital
Ústí nad Labem

Other trials in Czechia

Slovakia1 site

ÚVN SNP
Ružomberok

Other trials in Slovakia

Venezuela1 site

Instituto de Columna de Caracas
Caracas

Other trials in Venezuela

About this study

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
Medical subject headings: Intervertebral Disc Degeneration, Intervertebral Disc Displacement

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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'.
Measured: 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)
Measured: Patients were followed up according to the local practice, up to 1 year

Secondary outcomes (4)

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).
Measured: 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.
Measured: 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.
Measured: Up to 12 months follow up visit
Changes in Device Placement
Measured: Up to 12 months follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Oct 2011

First posted27 Apr 2010 (estimated)
Study startApr 2010
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Disc Disease, LumbarStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01110967
Sponsor's protocol ID: Satellite Retrospective
Status last verified: Jan 2016
First submitted: 15 Apr 2010
Last updated: 28 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Satellite™ PEEK Nucleus Replacement Retrospective Analysis
ClinicalTrials.gov ID: NCT01110967
Acronym / sponsor ID: Satellite Retrospective
Conditions: Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 27 Apr 2010 (estimated)
Results: Posted 7 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Patient has not reached the age of legal consent according to local laws

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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'.
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

4 secondary outcomes

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

Results and safety

Results posted to the registry on 7 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Implanted With a Satellite Device	40	31

Primary outcome: Health-related Quality of Life Using the Visual Analogue Scale for Back Pain

Time frame: Up to 12 months follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Implanted With a Satellite Device n = 32
Back pain pre-operative (n = 32)	5.5 (2.7)
Back pain at 1 month Follow up (n = 25)	2.6 (2.2)
Back pain at 3 months Follow up (n = 25)	2.2 (2.3)
Back pain at 6 months Follow up (n = 18)	1.9 (1.8)
Back pain at 12 months Follow up (n = 26)	1.3 (1.6)

Primary outcome: Health-related Quality of Life Using the Visual Analogue Scale for Leg Pain

Time frame: Up to 12 months follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Implanted With a Satellite Device n = 30
Leg pain pre-operative (n = 30)	7.2 (2.0)
Leg pain at 1 month Follow up (n = 25)	1.8 (2.1)
Leg pain at 3 months Follow up (n = 25)	1.0 (1.3)
Leg pain at 6 months Follow up (n = 18)	0.3 (0.8)
Leg pain at 12 months Follow up (n = 26)	0.3 (0.8)

Primary outcome: Physical Functioning Using the Oswestry Disability Index (ODI)

Time frame: Up to 12 months follow up visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Implanted With a Satellite Device n = 38
ODI pre-operative (n = 38)	48.2 (19.6)
ODI at 1 month Follow up (n = 26)	23.2 (16.0)
ODI at 3 months Follow up (n = 30)	18.6 (12.4)
ODI at 6 months Follow up (n = 23)	17.5 (13.0)
ODI at 12 months Follow up (n = 29)	11.4 (9.2)

Primary outcome: 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. Number. Unit: events

Measure	Patients Implanted With a Satellite Device n = 40
Value	7

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were followed up according to the local practice, up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Implanted With a Satellite Device	1 of 40 (2.5%)	6 of 40 (15%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, Lumbar and Disc Herniation, Lumbar, run by Medtronic Spinal and Biologics at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Czechia, Slovakia, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related Quality of Life Using the Visual Analogue Scale for Back Pain (time frame: Up to 12 months follow up visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01110967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.