- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947583
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
January 7, 2014 updated by: NuVasive
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF): Evaluation of Radiographic and Patient Outcomes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus in subjects who receive TLIF 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 TLIF 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 BMP.
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Existing clinic patients
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the fusion rates of Osteocel Plus in one or two level(s) for TLIF subjects.
Time Frame: from pre-op to 24-month follow-up
|
from pre-op to 24-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the rate of complications for Osteocel Plus and compare to published and/or retrospective data for autograft or bone morphogenetic protein (BMP).
Time Frame: from pre-op to 24-month follow-up
|
from pre-op to 24-month follow-up
|
To evaluate and compare radiographic outcome with respect to clinical outcome (function and pain).
Time Frame: from pre-op to 24-month follow-up
|
from pre-op to 24-month follow-up
|
To evaluate and compare each outcome with respect to surgical time and blood loss.
Time Frame: from pre-op to 24-month follow-up
|
from pre-op to 24-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
July 24, 2009
First Submitted That Met QC Criteria
July 27, 2009
First Posted (Estimate)
July 28, 2009
Study Record Updates
Last Update Posted (Estimate)
January 8, 2014
Last Update Submitted That Met QC Criteria
January 7, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUVA.OC-0804
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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