Status:
COMPLETED
Osteocel® Plus in Posterior Lumbar Interbody Fusion (PLIF)
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Eligibility:
FEMALE
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 a PLIF procedure. Due to the unique processing conditions, Ost...
Detailed Description
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive PLIF 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 :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00941980
Start Date
June 1 2009
End Date
October 1 2012
Last Update
December 24 2025
Active Locations (1)
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1
Spine, Orthopaedic Rehabilitation Center, Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102