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

Completed

Conditions studied: Degenerative Disc Disease, Back Pain

In brief

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).

Key facts

Study ID

NCT00948532

Run by

NuVasive

People needed

104

Starts

2009-03-01

Expected to finish

2012-10-01

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older, up to 80. 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 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

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

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

Full record on ClinicalTrials.gov

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