Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
1 other identifier
observational
19
1 country
1
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 TLIF procedure. Due to the unique processing conditions, Osteocel Plus retains a high concentration of stem cells in conjunction with the allograft bone matrix, so it is hypothesized that the fusion rate with Osteocel Plus will be comparable to published data for autograft. The Osteocel product family has already been used in approximately 15,000 cases worldwide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 24, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedDecember 24, 2025
December 1, 2025
3.4 years
July 24, 2009
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for TLIF subjects.
from pre-op to 24-month follow-up
Secondary Outcomes (3)
To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
from pre-op to 24-month follow-up
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
from pre-op to 24-month follow-up
To evaluate and compare each outcome with respect to surgical time and blood loss.
from pre-op to 24-month follow-up
Interventions
biologic
Eligibility Criteria
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 S1)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NuVasivelead
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2009
First Posted
July 28, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 24, 2025
Record last verified: 2025-12