Degenerative Disc DiseaseNCT00758719
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
An observational study of Degenerative Disc Disease, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- How many people
- 53 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2008to Aug 2012
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is open to all patients with one or two level Degenerative Disease who are between the ages of 18 and 75.
Who may be able to join
- The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
- Subjects must be between 18 and 75 years of age.
- The patient must be skeletally mature (epiphyses closed).
Who cannot join
- Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
- Any active litigation.
- Subject is currently involved in another investigational study.
- Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- Subject is incarcerated.
- More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated.
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- Traumatic instability.
- Any parathyroid or metabolic bone disease.
- Any active malignancy.
- Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of 6. All subjects with a SCORE value greater than 6 will be referred for Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Orthopedics and Neurological Consultants, Inc
Columbus, Ohio, 43212
Family Orthopedic Associates
Flint, Michigan, 48507
Union Hospital Neurosurgical
Terre Haute, Indiana, 47807
Neurological Associates of Waukesha
Waukesha, Wisconsin, 53188
About this study
Official title: A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
Read the detailed description
All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer
- Conditions
- Degenerative Disc Disease
- Keywords
- Spinal Fusion, Degenerative Disc Disease
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion
Measured: 12 Month
Secondary outcomes (7)
Visual Analog Scale (VAS) change from baseline
Mean VAS % change from baseline
Measured: 24 Months
Oswestry Disability Index change from baseline
Oswestry Disability Index % change from baseline
Measured: 24 Month
Neurologic Assessment, Maintenance or improvement from baseline
Measured: 12 Month
Short Form Health Survey (SF-36) % change from baseline
Measured: 24 Month
Time to return to work
Measured: 24 month
Time to return to normal activity
Measured: 24 month
Narcotic Use
pre and post-operatively
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 posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2012
- Study completionAug 2012
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
- Other
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Batts, Study director, Biomet Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758719
- Sponsor's protocol ID
- CS-045
- Status last verified
- Feb 2020
- First submitted
- 9 Sep 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
- A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
- ClinicalTrials.gov ID
- NCT00758719
- Acronym / sponsor ID
- CS-045
- Conditions
- Degenerative Disc Disease
- Keywords
- Spinal Fusion, Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Sep 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 study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
Detailed description
All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is open to all patients with one or two level Degenerative Disease who are between the ages of 18 and 75.
Key inclusion criteria (4 listed)
- The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.
- The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion.
- Subjects must be between 18 and 75 years of age.
- The patient must be skeletally mature (epiphyses closed).
Key exclusion criteria (10 listed)
- Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study.
- Any active litigation.
- Subject is currently involved in another investigational study.
- Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
- Subject is incarcerated.
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
Radiographic Fusion
Time frame: 12 Month
7 secondary outcomes
Visual Analog Scale (VAS) change from baseline
Time frame: 24 Months
Oswestry Disability Index change from baseline
Time frame: 24 Month
Neurologic Assessment, Maintenance or improvement from baseline
Time frame: 12 Month
Short Form Health Survey (SF-36) % change from baseline
Time frame: 24 Month
Time to return to work
Time frame: 24 month
Time to return to normal activity
Time frame: 24 month
Narcotic Use
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
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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.
Joel Batts study director
Biomet Spine
4 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, run by Zimmer Biomet at 4 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 4 inclusion and 10 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 4 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?
Radiographic Fusion (time frame: 12 Month). 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; AzTrials last refreshed its copy on 7 Nov 2026.