Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

NCT00948831 | Completed

• 1 other identifier: NUVA.OC-0803
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF 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, Lumbar

Keywords

biologics; fusion rates; lumbar fusion; ALIF

Outcome Measures

Primary Outcomes (1)

• To evaluate the fusion rates of Osteocel Plus in one or two level(s) for ALIF subjects.

  from pre-op to 24-months 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).

  from pre-op to 24-month follow-up

• To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).

  from pre-op to 24-months post-op

• To evaluate and compare each outcome with respect to surgical time and blood loss.

  pre-op to 24-month follow-up

Interventions

Osteocel Plus BIOLOGICAL

biologic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing clinic patients

You may qualify if:

• 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 S1)
• Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (7)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

OrthoIndy, Indiana Orthopedic Hospital

Indianapolis, Indiana, 46278, United States

Location

Indiana Spine Group, St. Joseph's Hospital

Kokomo, Indiana, 46901, United States

Location

Twin Cities Orthopaedics, University of Minnesota Medical Center

Edina, Minnesota, 55435, United States

Location

Ortho Montana

Billings, Montana, 59101, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Central Texas Spine Institute, Northwest Hills Surgical Hospital

Austin, Texas, 78731, United States

Location

Related Links

• NuVasive, Inc.

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 29, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (7)