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

NCT00948532 | Completed

• 1 other identifier: NUVA.OC.0801
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 13

Brief 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. 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).

Conditions

Degenerative Disc Disease; Back Pain

Keywords

degenerative disc disease; lumbar spine; XLIF; Degenerative conditions

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with radiographically apparent fusion.

  6-months, 12-months and 24-months

Secondary Outcomes (6)

• The evaluation of angular displacement on flexion/extension films.

  Post-op, 6-week, 3-month, 6-month, 12-month, 24-month

• The evaluation of bridging bone on CT.

  6-month, 12-month

• Preservation of interbody height over time.

  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.

  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).

  from baseline through post-operation follow-up (visits at post-op, 6-week, 3-month, 6-month, 12-month and 24-months)

Interventions

biologic, Osteocel Plus BIOLOGICAL

Osteocel® Plus

Also known as: Osteocel® Plus

Eligibility Criteria

• Age: 18 Years - 80 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 L5)
• 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 (13)

Shiley Center for Orthopaedic, Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Broward Spine Institute

Hollywood, Florida, 33021, United States

Location

South Florida Spine Institute, Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Southeastern Spine Center, Doctors Hospital of Sarasota

Sarasota, Florida, 34232, United States

Location

USF, Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Pinnacle Orthopaedics, Wellstone Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

The Spine Center of DuPage Medical Group, Edward Hospital

Naperville, Illinois, 60540, United States

Location

Indiana Center for Neurosurgery

Indianapolis, Indiana, 46219, United States

Location

Columbia Orthopaedic Group, Boone Hospital Center

Columbia, Missouri, 65205, United States

Location

Spine Midwest, St. Mary's Health Center

Jefferson City, Missouri, 65101, United States

Location

Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada

Las Vegas, Nevada, 89109, United States

Location

Buffalo Spine Surgery, Kenmore Mercy

Lockport, New York, 14094, United States

Location

Duke University Medical Center

Chapel Hill, North Carolina, 27710, United States

Location

Related Links

• NuVasive, Inc.

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Kelli Howell, MS

  NuVasive

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 29, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (13)