Degenerative Disc Disease in Cervical SpineNCT00942045
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
An observational study of Degenerative Disc Disease in Cervical Spine, run by NuVasive at 17 sites in United States.
Trial summary
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Degenerative Disc Disease in Cervical Spine
- What is being tested?
- Biologic - Osteocel Plus
- How many people
- 182 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2009to Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Existing clinic patients
Who may be able to join
- Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
- Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-70 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
- Expected to survive at least 2 years beyond surgery
- Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
- Signed and dated Informed Consent Form
Who cannot join
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Cervical spine abnormality requiring treatment at more than two levels
- Systemic or local infection; active or latent
- Previous failed fusion at the operative level
- Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
- Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
Show all 11Show fewer
- Pregnant, or plans to become pregnant during the study
- Subject is a prisoner
- Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
- A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents that decrease the probability of survival to the two-year endpoint of the study
- Participating in another clinical study at any time during the study participation that would confound study data
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
NWREI (for Ortho Montana)
Billings, Montana, 59101
The Center for Advanced Orthopaedics, Adena Bone and Joint Center
Chillicothe, Ohio, 45601
Columbia Orthopaedic Group, Boone Hospital Center
Columbia, Missouri, 65201
Duke University Medical Center
Durham, North Carolina, 27708
Indiana Center for NeuroSurgery, Indiana Surgery Center East
Indianopolis, Indiana, 46219
Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
Joliet, Illinois, 60435
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, 92037
Buffalo Spine Surgery, Kenmore Mercy
Lockport, New York, 14094
Pinnacle Orthopaedics, Wellstone Kennestone Hospital
Marietta, Georgia, 30060
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Stanford University
Redwood City, California, 94063
UCSD Department of Orthpaedic Surgery, UCSD Medical Center
San Diego, California, 92103
The Spine Institute, St. John's Health Center
Santa Monica, California, 90404
Swedish Medical Center
Seattle, Washington, 98122
Spine Team Texas, Texas Health Harris Methodist Hospital Southlake
Southlake, Texas, 76092
University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, 33606
Winchester Medical Center
Winchester, Virginia, 22601
About this study
Official title: Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
Read the detailed description
A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
- Being tested
- Biologic - Osteocel Plus
- Keywords
- cervical spine, ACDF, biologics, fusion rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic - Osteocel PlusBiological
Osteocel Plus
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
Measured: from pre-op to 24-month follow-up
Secondary outcomes (3)
To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
Measured: from pre-op to 24-month follow-up
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
Measured: from pre-op to 24-month post-op
To evaluate and compare each outcome with respect to surgical time and blood loss.
Measured: from pre-op to 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc Disease in Cervical SpineStudies 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
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelli Howell, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942045
- Sponsor's protocol ID
- NUVA.OC.0802
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2009
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF): Evaluation of Radiographic and Patient Outcomes
- ClinicalTrials.gov ID
- NCT00942045
- Acronym / sponsor ID
- NUVA.OC.0802
- Keywords
- cervical spine, ACDF, biologics, fusion rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Jul 2009 (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.
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ACDF surgery at one or two levels. These subjects will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any other biologic product, during their ACDF operation. The ACDF procedure will be conducted with a radiolucent graft containment device such that progression of fusion can be adequately assessed via radiograph. Subjects will be followed for 24-months following surgery to determine the number of study subjects that are solidly fused at or before 24 months postoperatively, and to determine the mean time to fusion. This data will be compared to published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic Protein (BMP).
Detailed description
A total of 175 subjects will be selected for enrollment in this study from multiple centers. The subjects will have degenerative conditions in the cervical spine and will be undergoing ACDF surgery as treatment at one or two levels. The following eligibility criteria are designed to select subjects for whom protocol treatment is considered appropriate. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing clinic patients
Key inclusion criteria (8 listed)
- Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner
- Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-70 years of age at the date of written informed consent
- Able to undergo surgery based on physical exam, medical history and surgeon judgment
Key exclusion criteria (11 listed)
- Patient has a mental or physical condition that would limit the ability to comply with study requirements
- Cervical spine abnormality requiring treatment at more than two levels
- Systemic or local infection; active or latent
- Previous failed fusion at the operative level
- Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic - Osteocel PlusOsteocel Plus | Biological | – |
Primary outcome
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects.
Time frame: from pre-op to 24-month follow-up
3 secondary outcomes
To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
Time frame: from pre-op to 24-month follow-up
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
Time frame: from pre-op to 24-month post-op
To evaluate and compare each outcome with respect to surgical time and blood loss.
Time frame: from pre-op to 24-month follow-up
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 Dec 2025.
- NuVasive, Inc.Link provided by the sponsor.
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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.
Kelli Howell, MS study director
NuVasive
17 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 in Cervical Spine, run by NuVasive at 17 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 8 inclusion and 11 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ACDF subjects. (time frame: from pre-op to 24-month follow-up). 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 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.