Status:
COMPLETED
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease, Lumbar
Eligibility:
All Genders
18-70 years
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, Os...
Detailed Description
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive ALIF surgery at one or two levels. These subjects will present with degenerative co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00948831
Start Date
April 1 2009
End Date
October 1 2012
Last Update
December 24 2025
Active Locations (7)
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1
University of California at San Francisco
San Francisco, California, United States, 94143
2
OrthoIndy, Indiana Orthopedic Hospital
Indianapolis, Indiana, United States, 46278
3
Indiana Spine Group, St. Joseph's Hospital
Kokomo, Indiana, United States, 46901
4
Twin Cities Orthopaedics, University of Minnesota Medical Center
Edina, Minnesota, United States, 55435