Degenerative Disc DiseaseNCT00948532
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
An observational study of Degenerative Disc Disease and Back Pain, run by NuVasive at 13 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 XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Disc Disease, Back Pain
- What is being tested?
- biologic, Osteocel Plus
- How many people
- 104 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Existing clinic patients
Who may be able to join
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
- Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-80 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
- Lumbar 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
- Participating in another clinical study that would confound study data
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Duke University Medical Center
Chapel Hill, North Carolina, 27710
Columbia Orthopaedic Group, Boone Hospital Center
Columbia, Missouri, 65205
Broward Spine Institute
Hollywood, Florida, 33021
Indiana Center for Neurosurgery
Indianapolis, Indiana, 46219
Spine Midwest, St. Mary's Health Center
Jefferson City, Missouri, 65101
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, 92037
Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
Las Vegas, Nevada, 89109
Buffalo Spine Surgery, Kenmore Mercy
Lockport, New York, 14094
Pinnacle Orthopaedics, Wellstone Kennestone Hospital
Marietta, Georgia, 30060
South Florida Spine Institute, Mount Sinai Medical Center
Miami Beach, Florida, 33140
The Spine Center of DuPage Medical Group, Edward Hospital
Naperville, Illinois, 60540
Southeastern Spine Center, Doctors Hospital of Sarasota
Sarasota, Florida, 34232
USF, Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®): 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 XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. 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
Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
- Conditions
- Degenerative Disc Disease, Back Pain
- Being tested
- biologic, Osteocel Plus
- Keywords
- degenerative disc disease, lumbar spine, XLIF, Degenerative conditions
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic, Osteocel PlusBiological
Also called Osteocel® Plus
Osteocel® Plus
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with radiographically apparent fusion.
Measured: 6-months, 12-months and 24-months
Secondary outcomes (6)
The evaluation of angular displacement on flexion/extension films.
Measured: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The evaluation of bridging bone on CT.
Measured: 6-month, 12-month
Preservation of interbody height over time.
Measured: All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The rate of complications attributable to the use of Osteocel Plus requiring intervention.
Measured: All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The change in subject self-reported pain ratings (VAS scores).
Measured: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
The change in Oswestry Disability Index scores.
Measured: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startMar 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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 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
- NCT00948532
- Sponsor's protocol ID
- NUVA.OC.0801
- 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 eXtreme Lateral Interbody Fusion (XLIF®): Evaluation of Radiographic and Patient Outcomes
- ClinicalTrials.gov ID
- NCT00948532
- Acronym / sponsor ID
- NUVA.OC.0801
- Conditions
- Degenerative Disc Disease, Back Pain
- Keywords
- degenerative disc disease, lumbar spine, XLIF, Degenerative conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 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 XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels. These subjects will present with degenerative conditions in the lumbar spine that are amenable to surgical treatment and will be screened prior to study enrollment. Subjects will receive Osteocel Plus during their XLIF operation. 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
Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated with the autograft harvest. Mesenchymal stem cells, like those found in Osteocel Plus, are naturally occurring in the body and can differentiate into a variety of tissue types, depending on the local environment. Once implanted, MSCs can differentiate into osteoblasts, which produce new bone matrix. MSCs also naturally secrete bone-inducing growth factors that signal the patient's endogenous cells to migrate and participate in the bone formation process. Osteocel Plus is different from other orthobiologic products such as DBM and allograft cancellous bone because it contains living stem cells, which provide osteogenic potential. The cells include mesenchymal stem cells from an adult human donor; they are not from an embryonic source.
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel in an XLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Existing clinic patients
Key inclusion criteria (8 listed)
- Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
- Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
- Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
- 18-80 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
- Lumbar 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 PlusAlso: Osteocel® PlusOsteocel® Plus | Biological | – |
Primary outcome
The proportion of subjects with radiographically apparent fusion.
Time frame: 6-months, 12-months and 24-months
6 secondary outcomes
The evaluation of angular displacement on flexion/extension films.
Time frame: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The evaluation of bridging bone on CT.
Time frame: 6-month, 12-month
Preservation of interbody height over time.
Time frame: All post-operative follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The rate of complications attributable to the use of Osteocel Plus requiring intervention.
Time frame: All study follow-up visits: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
The change in subject self-reported pain ratings (VAS scores).
Time frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
The change in Oswestry Disability Index scores.
Time frame: from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)
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
13 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 Back Pain, run by NuVasive at 13 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 13 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?
The proportion of subjects with radiographically apparent fusion. (time frame: 6-months, 12-months and 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 Dec 2025.