Degenerative Cervical Disc DiseaseNCT00875810
PRESTIGE Observational Study
An observational study of Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics at 26 sites in 8 countries.
Trial summary
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Cervical Disc Disease
- How many people
- 194 participants
- Where
- 26 sitesin 8 countries
- Study dates
- Apr 2008to Nov 2013
- 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: Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.
Who may be able to join
- Patient must be willing to sign a Patient Data Release Form.
- Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Who cannot join
- Patient fulfills any contraindication according to the product description.
- Patient has not reached the age of legal consent according to local laws.
- Patient has diabetes.
- Patient has Body Mass Index (BMI) > 35.
- Patient has affected disc not between C3/C4 and C6/C7.
- Patient with instability of cervical spine.
- Patients who will receive extensive decompression.
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
Poland10 sites
Centrum Ksztalcenia I Rehabilitcji
Konstancin, 05-510
Centrum Ksztalcenia I Rehabilitcji
Konstancin
Centrum Rehabilitacji im.prof. M.Weissa "STOCER"
Konstancin
Centrum Rehabilitacji im.prof.M.Weissa "STOCER"
Konstancin-Jeziorna, 05-510
State Hospital- Wojewodzkie Centrum
Opole, 45-418
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin, 70-891
Specialist Hospital Prof. Alfreda Sokolowskiego
Szczecin
Orthopaedic University Hospital in Zakopane
Zakopane, 34-500
Orthopaedic University Hospital in Zakopane
Zakopane
State Hospital- Szpital Wojewodzki
Zielona Góra, 65-046
Serbia6 sites
Neurosurgical Clinic KCS
Belgrade, 11000
Neurosurgical Clinic KCS
Belgrade
Clinical Center Nis Neurosurgical Clinic
Niš, 18000
Clinical Center Niš
Niš
Clinical Center of Vojvodina Neurosurgical Clinic
Novi Sad, 21000
Clinical Center of Vojvodina
Novi Sad
Czechia3 sites
Hospital Plzen - Lochotin
Pilsen, 32318
Hospital Plzen - Lochotin
Pilsen
University Clinic Motol
Prague
Hungary2 sites
National Center for Spinal Disorders
Budapest, 1126
National Center for Spinal Disorders
Budapest
Kuwait2 sites
Al-Salam International Hospital
Kuwait City
Razi Hospital for Orthopedic Surgery
Kuwait City
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Jeddah
About this study
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.
The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
Read the detailed description
Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.
Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.
The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.
Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.
Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.
The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.
- Conditions
- Degenerative Cervical Disc Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).
EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.
Measured: 2 years
Neck Disability Index (NDI) Score
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI).
The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.
Measured: 2 years
Secondary outcomes (2)
Duration of Pain Prior to Enrollment
Documentation of duration of pain prior to enrollment
Measured: Baseline visit
Intervertebral Disc Space
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionNov 2013
- Study completionNov 2013
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 Cervical Disc DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Štulik, MUDr, Principal investigator, University Clinic Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875810
- Sponsor's protocol ID
- PRESTIGE Observational Study
- Status last verified
- Jan 2016
- First submitted
- 1 Apr 2009
- Last updated
- 28 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- PRESTIGE Observational Study
- ClinicalTrials.gov ID
- NCT00875810
- Acronym / sponsor ID
- PRESTIGE Observational Study
- Conditions
- Degenerative Cervical Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 17 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.
The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
Detailed description
Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.
Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.
The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.
Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.
Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.
The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.
Key inclusion criteria (2 listed)
- Patient must be willing to sign a Patient Data Release Form.
- Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Key exclusion criteria (7 listed)
- Patient fulfills any contraindication according to the product description.
- Patient has not reached the age of legal consent according to local laws.
- Patient has diabetes.
- Patient has Body Mass Index (BMI) > 35.
- Patient has affected disc not between C3/C4 and C6/C7.
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
EQ-5D
Time frame: 2 years
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death.
Neck Disability Index (NDI) Score
Time frame: 2 years
The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation.
2 secondary outcomes
Duration of Pain Prior to Enrollment
Time frame: Baseline visit
Intervertebral Disc Space
Time frame: 2 years
Results and safety
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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PMCF Study Fortilink-SC
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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.
Jan Štulik, MUDr principal investigator
University Clinic Motol
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Cervical Disc Disease, run by Medtronic Spinal and Biologics at 26 sites in 8 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 7 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 26 sites in Poland, Serbia, Czechia, Hungary, Kuwait and 3 more countries. 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 17 Mar 2015). 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?
EQ-5D (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.