Status:
COMPLETED
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
Lead Sponsor:
NuVasive
Conditions:
Degenerative Disc Disease
Back Pain
Eligibility:
All Genders
18-80 years
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 subje...
Detailed Description
Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells (MSCs) which is intended to mimic the biologic performance of autograft without the morbidity associated wit...
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 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
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 :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00948532
Start Date
March 1 2009
End Date
October 1 2012
Last Update
December 24 2025
Active Locations (13)
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1
Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, United States, 92037
2
Broward Spine Institute
Hollywood, Florida, United States, 33021
3
South Florida Spine Institute, Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
4
Southeastern Spine Center, Doctors Hospital of Sarasota
Sarasota, Florida, United States, 34232