Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)

Completed

Conditions studied: Degenerative Disc Disease, Lumbar

In brief

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.

Key facts

Study ID

NCT00948831

Run by

NuVasive

People needed

51

Starts

2009-04-01

Expected to finish

2012-10-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• OrthoIndy, Indiana Orthopedic Hospital — Indianapolis, Indiana, United States
• Indiana Spine Group, St. Joseph's Hospital — Kokomo, Indiana, United States
• Twin Cities Orthopaedics, University of Minnesota Medical Center — Edina, Minnesota, United States
• Ortho Montana — Billings, Montana, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Central Texas Spine Institute, Northwest Hills Surgical Hospital — Austin, Texas, United States

Full record on ClinicalTrials.gov

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