Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)

December 17, 2025 updated by: NuVasive

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Shiley Center for Orthopaedic, Scripps Green Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Broward Spine Institute
      • Miami Beach, Florida, United States, 33140
        • South Florida Spine Institute, Mount Sinai Medical Center
      • Sarasota, Florida, United States, 34232
        • Southeastern Spine Center, Doctors Hospital of Sarasota
      • Tampa, Florida, United States, 33606
        • USF, Tampa General Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Pinnacle Orthopaedics, Wellstone Kennestone Hospital
    • Illinois
      • Naperville, Illinois, United States, 60540
        • The Spine Center of DuPage Medical Group, Edward Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Indiana Center for Neurosurgery
    • Missouri
      • Columbia, Missouri, United States, 65205
        • Columbia Orthopaedic Group, Boone Hospital Center
      • Jefferson City, Missouri, United States, 65101
        • Spine Midwest, St. Mary's Health Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
    • New York
      • Lockport, New York, United States, 14094
        • Buffalo Spine Surgery, Kenmore Mercy
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Existing clinic patients

Description

Inclusion Criteria:

  1. Persistent back and/or leg pain unresponsive to conservative treatment for at least six (6) months, unless clinically indicated earlier
  2. Indicated for interbody fusion of one or two contiguous lumbar segments (L1 to L5)
  3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
  4. 18-80 years of age at the date of written informed consent
  5. Able to undergo surgery based on physical exam, medical history and surgeon judgment
  6. Expected to survive at least 2 years beyond surgery
  7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol
  8. Signed and dated Informed Consent Form

Exclusion Criteria:

  1. Patient has a mental or physical condition that would limit the ability to comply with study requirements
  2. Lumbar spine abnormality requiring treatment at more than two levels
  3. Systemic or local infection; active or latent
  4. Previous failed fusion at the operative level
  5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease)
  6. 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)
  7. Pregnant, or plans to become pregnant during the study
  8. Subject is a prisoner
  9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended)
  10. 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
  11. Participating in another clinical study that would confound study data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of subjects with radiographically apparent fusion.
Time Frame: 6-months, 12-months and 24-months
6-months, 12-months and 24-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The evaluation of angular displacement on flexion/extension films.
Time Frame: Post-op, 6-week, 3-month, 6-month, 12-month, 24-month
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
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
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
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)
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)
from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NuVasive

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kelli Howell, MS, NuVasive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2009

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NUVA.OC.0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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