Degenerative Disc DiseaseSPONCT00726284
Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by Zimmer Biomet at 5 sites in United States.
Trial summary
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis
- How many people
- 651 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2004to 6 Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This is an open cohort prospective patient registry conducted at multiple clinical centers
Who may be able to join
- N/A
Who cannot join
- N/A
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CNS Healthcare
Akron, Ohio, 44333
Neurological Surgery Associates
Little Rock, Arkansas, 72205
Florida Orthopedics Association
Orange City, Florida, 32763
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464
Oklahoma Spine and Brain
Tulsa, Oklahoma, 74132
About this study
Official title: BIOMET/EBI (Electro-Biology, Inc) Spine Patient Outcomes Registry
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
Read the detailed description
A patient registry to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis
- Keywords
- Herniated nucleus pulposus (HNP)
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Status
The primary outcome measure for this trial will be the percentage of successful fusions achieved.
Measured: 24 Months
Secondary outcomes (4)
Mean VAS (Visual Analog Scale) Score Change from baseline
Measured: 24 Month
Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline
Measured: 24 Month
neurologic Assessment - maintenance or Improvement
Measured: 24 Month
SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startApr 2004
- Primary completion6 Dec 2007
- Study completion6 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Evangelsita, MD, Study director, EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726284
- Sponsor's protocol ID
- CS-006
- Acronym
- SPO
- Status last verified
- Feb 2020
- First submitted
- 29 Jul 2008
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOMET/EBI (Electro-Biology, Inc) Spine Patient Outcomes Registry
- ClinicalTrials.gov ID
- NCT00726284
- Acronym / sponsor ID
- SPO / CS-006
- Conditions
- Degenerative Disc Disease, Spinal Stenosis
- Keywords
- Herniated nucleus pulposus (HNP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- 6 Dec 2007 (actual)
- Study completion
- 6 Dec 2007 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
Detailed description
A patient registry to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is an open cohort prospective patient registry conducted at multiple clinical centers
Key inclusion criteria (1 listed)
- N/A
Key exclusion criteria (1 listed)
- N/A
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
Fusion Status
Time frame: 24 Months
The primary outcome measure for this trial will be the percentage of successful fusions achieved.
4 secondary outcomes
Mean VAS (Visual Analog Scale) Score Change from baseline
Time frame: 24 Month
Oswestry Disability Index / Neck Disability Index (which ever is appropriate for the subject) change from baseline
Time frame: 24 Month
neurologic Assessment - maintenance or Improvement
Time frame: 24 Month
SF-36 (Short Form Survey-36) Health Outcomes - Change from Baseline
Time frame: 24 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Degenerative Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
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.
John Evangelsita, MD study director
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Spinal Stenosis, run by Zimmer Biomet at 5 sites in United States.
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 1 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fusion Status (time frame: 24 Months). 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 24 Feb 2020.